Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
ACCESS TRAY/ASK-04001-JHH;
ACCESS TRAY/ASK-04001-LMDTG;
PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1;
3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2;
MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDT1;
MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDTG1;
MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PVH;
1L CVC KIT: 16 GA X 8 IN (20CM)/ASK-24301-JHH1;
CVC KIT: 16 GA X 16 CM/CDC-24306-1A;
CVC KIT: 3-L 7 FR X 30 CM ANTIMICROBIAL/CDC-24703-X1A;
LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-1A;
CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL3;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-ACH;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-BJC1;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-DU1;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-EMC;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-LMDT1;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-LMDTG1;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-MCY1;
MULTILUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-NS1;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAGP1;
PI CVC KIT: 3L 7 FR X 6 IN (16 CM)/ASK-42703-PAM1;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAMC2;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAU1;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 16/ASK-42703-PB1;
PI CVC KIT: 3L 7 FR X 16CM AGB+/ASK-42703-PBSWH2;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 IN/ASK-42703-PCAM1;
MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-PCSJ2;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PECL2;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PGM4;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHHN1;
MULTI LUMEN CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PLC;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMEM;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMHC1;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS1;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-POHU2;
MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU2;
MULTILUMEN CVC KIT 7 FR X 6 IN (16 CM)/ASK-42703-PTJH;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUCH2;
PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-PUCI1;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUHC2;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUMH;
MULTI-LUMEN PI CVC KIT: 3-L 7 FR/ASK-42703-PUPM1;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-SHUF2;
MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-SL1;
CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-42703-UMC;
PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-WHH;
CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-CHM;
CVC KIT: 2L 8 FR X 16 CM/ASK-42802-LMDT1;
PI CATHETER 2L: 8FR X 16CM AGB+/ASK-42802-MCY1;
PI CVC KIT: 2L 8FR X 16CM AGB+/ASK-42802-PBSWH2;
MULTILUMEN CVC KIT: 2L 8 FR X 6/ASK-42802-POSU2;
PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUNCC2;
PI CVC KIT: 2-L 8 FR/ASK-42802-PUPM1;
PI CVC KIT: 2L 8 FR/ASK-42802-TGH1;
PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-BJC1;
CVC KIT: 4L 8.5 FR X (16CM) AGB+/ASK-42854-PBMH;
PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-PMM;
PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-PUCH2;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-ACH;
3L CVC KIT: 7 FR X 20 CM AGB+/ASK-45703-ARM;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BJC1;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BLH;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-DU1;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-HHC4;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDT1;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDTG1;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-MCY1;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NO;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NS1;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PADV1;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PAGP1;
MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAMC1;
MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAU1;
PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PBSWH2;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PCAM1;
MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCSJ2;
PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PDM1;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PECL2;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/A
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: I.V. Start KitDistribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.Recall #Z-2384-2026
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
ACCESS TRAY/GU-04020;
PSI KIT: 8.5 FR/AK-09803-CDC;
PSI KIT: 9 FR/AK-09903-CDC;
PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1;
PSI KIT: 9 FR X 10 CM/ASK-09903-KH;
PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1;
PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA;
PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-YNH;
PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09907-SL;
PSI KIT: 8.5 FR X 4-1/8IN (10 CM)/NA-09803-CDC;
PSI KIT: 9 FR X 4-1/8IN (10 CM)/NA-09903-CDC;
PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL4;
PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-MGH3;
MULTI-LUMEN/PSI KIT/AK-11142-SPCS;
MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/CDC-11242-1A;
MULTI-LUMEN/PSI KIT/AK-11142-D;
MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-11142-MGH4;
MULTI-LUMEN/PSI KIT/NA-11242-CDC;
MULTI-LUMEN/PSI KIT/AK-21142-SK;
MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDTG;
MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-RH;
MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-IMC;
MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDTG;
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMD;
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UU3;
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-VCU;
MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-1A;
MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-X1A;
MULTI-LUMEN/PSI KIT/AK-21242-CDC;
2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH4;
MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-GH1;
2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-SUU;
2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC4;
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UKL;
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMF;
MULTILUMEN/PSI KIT: 9 FR X 4 1/2 IN/ASK-21242-UR1;
PSI KIT: 8.5 FR/AK-29803-CDC;
PSI KIT: 9 FR/AK-29903-CDC;
PSI KIT: 9 FR/AK-29907-CDC;
PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-UN1;
PSI KIT: 9 FR/ASK-09903-UM;
PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDT;
PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDTG;
PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-BID1;
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDTG;
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UMD;
PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UR1;
PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-X1A;
PSI KIT: 8.5 FR X 10 CM/ASK-29803-ECL;
PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM3;
PSI KIT: 9 FR X 10 CM/ASK-29903-ECL;
PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM3;
PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09907-TG1
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
PARACENTESIS KIT/ASK-00376-JHH
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Kit, Surgical Instrument, DisposableDistribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.Recall #Z-2386-2026
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Midline CatheterDistribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.Recall #Z-2387-2026
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F,
AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1,
AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM,
AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1,
AHDC KIT: 3-L 12 FR X 20 CM/ASK-15123-UPM,
AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-P1A,
AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XP1A,
AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPCN1A,
AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPN1A,
AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-P1A,
AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPCN1A,
AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPN1A,
AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPCN1A,
HEMODIALYSIS KIT 2L: 12 FR X 20CM AGB/AK-25122-CDC,
HEMODIALYSIS KIT: 2-LUMEN 14 FR X 20 CM/AK-25142-F,
HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM1,
HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM2,
AHDC KIT: 2L 14 FR X 15 CM/ASK-22142-UOC1,
AHDC AGB KIT: 2-L 14 FR X 15 CM/ASK-22142-UPM,
HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UNC1,
AHDC KIT: 2L 14 FR X 20 CM/ASK-25142-UOC1,
AHDC AGB KIT: 2L 14 FR X 20 CM/ASK-25142-UPM,
HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/ASK-26142-UNC1,
HEMODIALYSIS KIT: 2LUMEN 12 FR X 16 CM/AU-22122-F,
HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-1A,
AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A-U,
AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A,
AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A-U,
HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB/CDC-22142-1A,
HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-XC1A,
AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A,
AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A-C,
AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A,
AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A-C,
AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XCN1A-U,
AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XN1A-U,
HEMODIALYSIS KIT: 2L 12 FR X 13 CM AGB/CDC-23122-XU1A,
HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-1A,
HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-X1A,
AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A,
AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A-U,
AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A,
HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-XU1A,
HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/CDC-25142-1A,
HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB/CDC-25142-XC1A,
AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A,
AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A-C,
AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A,
AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A-C,
HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-1A,
AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XCN1A,
AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XN1A,
HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/CDC-26142-1A,
HEMODIALYSIS KIT: 2L 14 FR X 25 CM AGB/CDC-26142-X1A,
AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XCN1A,
AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XN1A,
HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-25122-F,
AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A,
LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XCN1A,
LBCVC AGB KIT: 3-L 12 FR X 20 CM/CDC-25123-XCN1A,
LBCVC AGB KIT:3-L 12 FR X 20 CM/CDC-25123-XN1A
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
SPINAL ANESTHESIA KIT/ASA-24090-SB;
SPINAL ANESTHESIA KIT/ASA-24103-SB;
SPINAL ANESTHESIA KIT/ASA-25090-SB;
SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA;
SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH;
SPINAL ANESTHESIA KIT/ASK-25090-BIDMC;
SPINAL ANESTHESIA KIT/ASK-25090-UF
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Needle, Conduction, Anesthetic (W/Wo Introducer)Distribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.Recall #Z-2389-2026
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B;
SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C;
SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Percutaneous Atrial Catheter KitDistribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.Recall #Z-2390-2026
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC;
RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW;
ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5;
CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH;
CATH S-L 20 GA X 5 CM HYDROPHILIC/ASK-00520-UHC;
ARTERIAL LINE KIT: 20 GA x 5IN/ASK-00820-CL;
RA CATH KIT: 20 GA X 8 CM X 12 CM/ASK-00820-WC;
ARTERIAL CATHETERIZATION KIT/ASK-01218-HM;
SAC KIT: 20 GA X 12CM/ASK-01220-HMH;
ARTERIAL CATH KIT: 20GA X 12CM/ASK-01220-NWM;
ARTERIAL CATH KIT: 20 GA X 12 CM/ASK-01220-UH;
ARTERIAL CATH: 18 GA X 6 1/2IN/ASK-01618-AU;
RA CATH KIT: 18 GA X 6 IN/ASK-01618-CL;
ARTERIAL CATH KIT: 18 GA X 6 1/2 IN/ASK-01618-JH;
ARTERIAL CATHETERIZATION KIT/ASK-01618-PH;
ARTERIAL CATH KIT: 18 GA X 6 1/2IN/ASK-01618-RU;
ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HF;
ARTERIAL CATH KIT: 18 GA X 6 IN (16 CM)/ASK-04018-NS;
ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-ST;
RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04120-BGH;
ART/VESS CATH KIT:20GAX4.45CM/20GAX12CM/ASK-04500-SM;
ARTERIAL LINE KIT/ASK-04500-UCH;
ARTERIAL LINE KIT/ASK-04510-EUH2;
ARTERIAL LINE KIT: 20GA X 5IN (12CM)/ASK-04510-MS4;
ARTERIAL LINE KIT/ASK-04510-UPM;
ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-1A;
ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-X1A;
ARTERIAL CATH KIT: 22GA X 5CM/SAC-00522-1A
ARTERIAL CATH KIT: 22 GA X 5CM/SAC-00522-X1A;
ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-1A;
ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-X1A;
SAC KIT: 18 GA X 12CM/SAC-01218-1A;
SAC KIT: 18 GA X 12CM/SAC-01218-X1A;
SAC KIT: 20 GA X 12CM/SAC-01220-1A;
SAC KIT: 20 GA X 12CM/SAC-01220-X1A;
SAC KIT: 18 GA X 16CM/SAC-01618-1A;
SAC KIT: 18 GA X 16CM/SAC-01618-X1A;
ACCESS TRAY/UM-04018;
RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-ABM;
RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-BGH;
RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LOL;
RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MHS;
RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-MIB3;
RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC1;
RA CATH SET: 20 GA X 1 3/4 IN/ASK-04020-URMC;
RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04220-FMH1;
RA CATH KIT: 20 GA X 4.45 CM/NA-04020-1A;
RA CATH KIT: 20 GA X 4.45 CM W BIO/NA-04020-B;
RA CATH KIT: 20 GA X 4.45 CM W CHG/NA-04020-C;
VESSEL CATH KIT: 20 GA X 5IN (12 CM)/ASK-04550-NYP;
CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04300-PHP1;
CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04301-TJ;
ARTERIAL ACCESS KIT/ASK-04001-VAMC1;
RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-WBH
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
ACCESS TRAY/ASK-04001-MC3
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Percutaneous Introducer KitDistribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.Recall #Z-2392-2026
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
PSI KIT: 7 FR X 4 IN/ASK-09701-UP;
PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5;
PSI KIT: 8.5 FR/ASK-09807-UC;
PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2;
PSI KIT: 9 FR X 10 CM/ASK-09903-LMDTG;
PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU5;
PSI KIT: 9 FR X 10 CM/CDC-09903-1A;
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-KSF2;
MAC TWO LUMEN/PSI KIT: 9 FR X 11.5 CM/ASK-11242-KSF1
AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-MCY1;
MULTI LUMEN PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU4;
MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/ASK-21242-UCD1;
2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-HHC
MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDT;
PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-CCH;
PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-MM2;
PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29903-DU1;
PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-HHC;
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDT;
PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-NWM;
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-SL1;
PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XCN1A;
PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-HF6;
PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-HHN1;
MULTI LUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-YWH;
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Percutaneous Sheath Introducer KitDistribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.Recall #Z-2393-2026
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A;
AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A;
AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A;
AGBA PI MIDLINE 1L: 4.5FR X 15CM/ASK-41541-VFHM;
AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPK;
AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKB;
AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKC;
AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPK;
AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKB;
AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKC;
PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPK;
PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPKB;
PI MIDLINE 1L: 4FR X 20CM/CDC-32041-MPKC;
PI MIDLINE 2-L: 5FR X 20CM/CDC-32052-MPKB;
PI PICC NaviCurve: 1L 4FR x 55CM w BP/DLX-35541-CURVB;
PI PICC: 1L 4FR x 55CM w Biopatch/DLX-35541-HPKB;
PI PICC: 1L 4FR x 55CM w CHG/DLX-35541-HPKC;
PI PICC: 2L 5FR x 55CM w Biopatch/DLX-35552-HPKB;
PI PICC: 2L 5FR X 55CM w CHG/DLX-35552-HPKC;
PI PICC: 3L 6FR x 55CM w Biopatch/DLX-35563-HPKB;
AGBA PICC/DELTA KIT: 1L 4.5 FR X 40 CM/ASK-44041-NS;
AGBA PICC/DELTA FG: 2L 5.5 FR X 40 CM/ASK-44052-NS;
AGBA PICC/DELTA KIT: 1L 4.5 FR X 50 CM/ASK-45041-NS;
PI PICC KIT: 2L 5.5 FR X 50 CM/ASK-45052-TG;
PI AGBA PICC KIT: 3L 6 FR X 50 CM W/VPS/ASK-45063-NS;
PICC KIT: 1L 4.5 FR X 55 CM CG+ VPS/ASK-45541-RH;
AGBA PICC: 1L 4.5FR x 55CM w Teg CHG/DLX-45541-HPKC;
AGBA PICC: 2L 5.5FR x 55CM w Teg CHG/DLX-45552-HPKC;
AGBA PICC NaviCurve: 3L 6FR x 55CM TCG/DLX-45563-CURVC;
AGBA PICC: 3L 6FR x 55CM w Biopatch/DLX-45563-HPKB;
AGBA PICC: 3L 6FR x 55CM w Teg CHG/DLX-45563-HPKC;
PI PICC KIT: 1-L 4 FR X 55 CM TIPTRACKER/CDC-35541-TTS;
PI PICC NaviCurve: 1L 4FR x 55CM w CHG/DLX-35541-CURVC;
PI PICC G4 Stylet: 1L 4FR x 55CM w BP/DLX-35541-VPSB;
PI PICC NaviCurve: 2L 5FR x 55CM w CHG/DLX-35552-CURVC;
PI PICC G4 Stylet: 2L 5FR x 55CM w BP/DLX-35552-VPSB;
PI PICC G4 Stylet: 2L 5FR x 55CM w CHG/DLX-35552-VPSC;
PI PICC NaviCurve: 3L 6FR x 55CM w CHG/DLX-35563-CURVC;
PI PICC G4 Stylet: 3L 6FR x 55CM w CHG/DLX-35563-VPSC;
AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM/CDC-44041-VPS2;
PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UWH1;
PI AGBA PICC KIT: 2L 5.5FR X 55CM W/ VPS/ASK-45552-UWH1;
AGBA PICC G4 Stylet: 1L 4.5FR x 55CM BP/DLX-45541-VPSB;
ACCESS TRAY/ASK-04001-NWM;
ACCESS TRAY/ASK-04001-VCUH3;
PI PICC:1L 4FR X 40CM PRELOAD VPS STYLET/CDC-34041-VPS;
PI PICC:2L 5FR X 50CM PRELOAD VPS STYLET/CDC-35052-VPS;
ACCESS KIT/ASK-04001-BWK2;
ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU11;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PVD;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 16CM/ASK-12703-LMDTG1;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 8IN/ASK-15703-ECMC4;
MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-15703-PNM;
CVC KIT: 3 LUMEN 12 FR X 6IN/ASK-22123-UAB;
2-L CVC KIT: 4 FR X13 CM/CDC-24402-X1A;
LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-X1A;
CVC KIT: 3L 7 FR X 16 CM/ASK-42703-CPR;
CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-DMC2;
CVC KIT: 2 LUMEN 8 FR X 8 IN (20 CM)/ASK-45802-PCMH1;
PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-MM1;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHUMC1;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMSG1;
MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU3;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PSAU1;
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-RHR1;
PI CATHETER 2L: 8 FR X 16 CM AGB+/ASK-42802-DU1;
PI CVC KIT: 2L 8 FR X 6 IN/ASK-42802-PHF4;
PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PHHN1;
MULTILUMEN CVC KIT: 2L 8 FR X 6 IN/ASK-42802-POSU3;
PI CVC KIT: 2-L 8 FR X 16 CM AGB+/ASK-42802-PUCD1;
MULTI-LUMEN CVC KIT:2-L 8FR X 6IN (16CM)/ASK-42802-PWHC1;
PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UHC;
PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-MCY1;
PI CVC KIT: 3L 7FR X 8IN (20 CM) AGB+/ASK-45703-BCH;
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-EMC;
PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-MHMC1;
PI CVC KIT: 3-L 7 FR X 20 CM AGB+/ASK-45703-NWM;
MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCOR;
MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PIMH;
MULTI LUMEN CVC KIT: 3L
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
PICC ACCESS TRAY/ASK-04001-CG1
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.Recall #Z-2395-2026
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
CVC KIT: 16 GA X 8IN/AK-04210,
CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300,
CVC KIT: 14 GA X 6 IN/CK-04711
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Syringe, PistonDistribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.Recall #Z-2396-2026
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
Description/REF:
RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A;
RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A;
ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA;
ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM;
RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC;
ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC;
RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC;
RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV;
ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1;
ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS;
RADIAL ARTERY KIT/ASK-04500-AH;
RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S;
ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA;
ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF;
ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1;
ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2;
ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS;
ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S;
ARTERIAL LINE KIT/HF-04510-1;
RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM;
RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1;
RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1;
RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS;
RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC;
RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT;
RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI;
RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS;
RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC;
RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB;
RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC;
RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH;
RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM;
RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1;
RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A;
RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1;
CVC KIT: 20 GA X 12CM/ASK-04510-UCLA;
ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Wire, Guide, Catheter
Open, ClassifiedPosted Jun 12, 2026·Initiated May 14, 2026
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes:
1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU.
2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.
3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.
4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN.
5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP.
6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.
7. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU.
9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.
10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN.
11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK.
12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US.
13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA.
14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU.
15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP.
16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.
17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK.
18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.
Reason: Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.Recall #Z-2360-2026 Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline EBSI Kit
EBSI1534
Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Root cause: Process control
Recalling firm: Medline Industries, LPType: Tray, SurgicalDistribution: US Nationwide distribution. OUS distribution pending.Recall #Z-2414-2026
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline CCI Nerve Block Tray
DYNJRA2742
Medline CPNB
DYNJRA2716
Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Root cause: Process control
Recalling firm: Medline Industries, LPType: Spinal Epidural Anesthesia KitDistribution: US Nationwide distribution. OUS distribution pending.Recall #Z-2415-2026
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
BLOCK TRAY
DYNJRA2119A
INDWELLING NERVE BLOCK
DYNJRA1011A
Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Root cause: Process control
Recalling firm: Medline Industries, LPType: Nasal Endotracheal Tube Holder KitDistribution: US Nationwide distribution. OUS distribution pending.Recall #Z-2416-2026
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
MINOR CATH LAB PACK
DYNJ84775A
OR VASCULAR ANGIO PACK
DYNJ47269D
PORT-A-CATH
DYNJ63276G
Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Root cause: Process control
Recalling firm: Medline Industries, LPType: Cardiac Catheterization KitDistribution: US Nationwide distribution. OUS distribution pending.Recall #Z-2417-2026
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline convenience kits:
LOOP PACK
DYNJ61460C
OPEN HEART
CDS840150Y
PACEMAKER
DYNJ56297C
PACEMAKER PK
DYNJT3454
PACEMAKER/ICD PACK
DYNJ33822L
PAD OPEN HEART
DYNJ900962O
PEDIATRIC OPEN HEART
DYNJ54238L
DYNJT6766
STAZ BASIC VASCULAR
DYNJ909794C
VASCULAR ACCESS KIT
CVI5323A
VASCULAR CDS
CDS983040M
Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Root cause: Process control
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: US Nationwide distribution. OUS distribution pending.Recall #Z-2418-2026