Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 3, 2024
ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A;
2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353;
3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A;
4) ECONO STERILE OLSEN-HEGAR NH DEL 5.5 STER 25, Model Number 96-2356A;
5) ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25, Model Number 96-2358A;
6) ECONO STERILE WEBSTER NH SERR JAW5.25" CS/25, Model Number 96-2417;
7) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/50, Model Number 96-2580;
8) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581;
9) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581A;
10) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583;
11) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583A;
12) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585;
13) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585A;
14) ECONO STERILE WEBSTER NH SMO 5.25" STER CS50, Model Number 96-2586;
15) ECONO STERILE WEBSTER NH SMO 5.25" STER CS25, Model Number 96-2587;
16) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/50, Model Number 96-2590;
17) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591;
18) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591A;
19) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/50, Model Number 96-2594;
20) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595;
21) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595A;
22) ECONO STERILE MAYO-HEGAR NH 5" STERILE CS/25, Model Number 96-2599;
23) ECONO STERILE WEBSTER NH SMO 5 1/4 STRL C100, Model Number 96-2659;
24) ECONO STERILE MAYO-HEGAR NH 7" STERILE CS/50, Model Number 96-2710;
25) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711;
26) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711A;
27) ECONO STERILE MAYO-HEGAR NH 8" STERILE CS/50, Model Number 96-2712;
28) ECONO STERILE WEBSTER NH FINE 5.25" STER 25, Model Number 96-2740A;
29) ECONO STERILE WEBSTER NH X-FIN LG 5" STER 25, Model Number 96-2741A;
30) ECONO STERILE WEBSTER NH X-FN SMO 5" STER 25, Model Number 96-2742A;
31) ECONO STERILE HALSEY NH SERR TC 5" STER CS25, Model Number 96-2745A; general orthopedic surgery
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Sklar InstrumentsType: Holder, Needle; OrthopedicDistribution: Domestic: Nationwide DistributionRecall #Z-0954-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Nov 27, 2024
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Reason: Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Root cause: Labeling Change Control
Recalling firm: IsoTis OrthoBiologics, Inc.Type: Filler, Bone Void, Calcium CompoundDistribution: US Nationwide distribution in the states of IN, TN & TX.Recall #Z-0955-2025
CompletedPosted Jan 16, 2025·Initiated Jun 21, 2021
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Reason: During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.
Root cause: Device Design
Recalling firm: Murata Vios, Inc.Type: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Distribution: Worldwide - US Nationwide distribution in the states of NY, LA and the country of India.Recall #Z-0956-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 2, 2024
McKesson Cardiology Hemo software
Reason: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Root cause: Software design
Recalling firm: A L I Technologies LtdType: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PA, SC, SD, TN, TX, WA, WI and the countries of Australia, Israel, Canada, Germany, Ireland, United Kingdom.Recall #Z-0957-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 2, 2024
Change Healthcare Cardiology Hemo software
Reason: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Root cause: Software design
Recalling firm: A L I Technologies LtdType: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PA, SC, SD, TN, TX, WA, WI and the countries of Australia, Israel, Canada, Germany, Ireland, United Kingdom.Recall #Z-0958-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 2, 2024
Change Healthcare Cardiology Hemodynamics software
Reason: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Root cause: Software design
Recalling firm: A L I Technologies LtdType: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PA, SC, SD, TN, TX, WA, WI and the countries of Australia, Israel, Canada, Germany, Ireland, United Kingdom.Recall #Z-0959-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 2, 2024
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Reason: Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
Root cause: Process control
Recalling firm: Accriva Diagnostics, Inc.Type: System, Automated Platelet AggregationDistribution: US Nationwide distribution in the state of VA.Recall #Z-0961-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 16, 2024
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30.
Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Reason: Potential for distal tip tearing of the Mechanical Lithotriptor V.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Lithotriptor, Biliary MechanicalDistribution: US Nationwide distribution.Recall #Z-0962-2025
Open, ClassifiedPosted Jan 15, 2025·Initiated Dec 16, 2024
Medline Fluid Delivery Set with Drip Chamber:
1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069;
2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222;
3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224;
4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, Item Number 949000221;
5) FDS,135,NV,MICRO-CHAMBER,W/FILTER,YELLOW, Item Number 949000223
Reason: Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Set, Administration, IntravascularDistribution: US Nationwide DistributionRecall #Z-0764-2025
Open, ClassifiedPosted Jan 15, 2025·Initiated Dec 16, 2024
Medline Fluid Delivery Set with Drip Chamber:
1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527;
2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341;
3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Number: 65232486;
4) MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM, Item Number: 65071193;
5) MTO,NEURO,FLUSH,SPIKE,KIT,BLUE,FLORIDA, Item Number: 600604422;
6) MTO,NEURO,KIT,-,JERSEY,SHORE PG, Item Number: 60100045;
7) MTO,RADIOLOGY,KIT,HAMOT MED CEN, Item Number: 650801715;
8) MTS,135,CDS,IV,TUBE-JEFFERSON UNIV., Item Number: 60232481;
9) MTS,135,YELLOW,MICRO,SPIKE,LUTHERAN MED, Item Number: 60120583;
10) MTS,ANGIO,NEURO,KIT,NORTH SHORE UNIV, Item Number: 601403920;
11) MTS,CUST. FILTER-NEWYORK UNIVERSITY, Item Number: 62140602;
12) MTS,INTERV,NEURO,KIT-WESTCHESTER,MC, Item Number: 602301614;
13) MTS,NEU,NORTH SHORE HOSPITAL, Item Number: 6010771601;
14) MTS,NEURO,KIT, Item Number: 600602914;
15) MTS,NEURO,KIT,2,NEWENGLAND MED CTR, Item Number: 601400111;
16) MTS,NEURO,KIT,YLW&RED,FLORIDA HOSP, Item Number: 600604423;
17) MTS,NEURO,KIT-JOHN,F,KENNEDY MED CENTER, Item Number: 60110552;
18) MTS,NEURO,KIT-OVERLOOK HOSPITAL PG, Item Number: 60150035;
19) MTS,NEURO,SPIKE,KIT,CAPITAL HLTHSYS-FULD, Item Number: 60182723;
20) MTS,NEURO-RADIOLOGY,KIT-YALE-NEWHAVEN, Item Number: 602500214;
21) MTS,STROKE/EMBO,KIT,NORTH SHORE UNIV, Item Number: 601403921;
22) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601305210;
23) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601400110;
Reason: Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cardiovascular Procedure KitDistribution: US Nationwide DistributionRecall #Z-0765-2025
Open, ClassifiedPosted Jan 15, 2025·Initiated Dec 12, 2024
Impella RP with SmartAssist; Product Number: 0046-0035;
Reason: Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Right Heart Support Blood PumpDistribution: Domestic: Nationwide Distribution
International: CanadaRecall #Z-0829-2025 Open, ClassifiedPosted Jan 15, 2025·Initiated Dec 12, 2024
Impella RP Flex with SmartAssist; Product Number: 1000323;
Reason: Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Right Heart Support Blood PumpDistribution: Domestic: Nationwide Distribution
International: CanadaRecall #Z-0830-2025 Open, ClassifiedPosted Jan 15, 2025·Initiated Dec 10, 2024
Medtronic NanoCross Elite PTA catheter,
REF numbers amd sizes:
1) AB14W050020090, Size: 5MM X 20MM X 90CM;
2) AB14W050020150, Size: 5MM X 20MM X 150CM;
3) AB14W050040090, Size: 5MM X 40MM X 90CM;
4) AB14W050040150, Size: 5MM X 40MM X 150CM;
5) AB14W050060150, Size: 5MM X 60MM X 150CM;
6) AB14W050080090, Size: 5MM X 80MM X 90CM;
7) AB14W050080150, Size: 5MM X 80MM X 150CM;
8) AB14W050100150, Size: 5MM X 100MM X 150CM;
9) AB14W050120150, Size: 5MM X 120MM X 150CM;
10) AB14W050150150, Size: 5MM X 150MM X 150CM;
11) AB14W050200090, Size: 5MM X 200MM X 90CM;
12) AB14W050200150, Size: 5MM X 200MM X 150CM;
13) AB14W060040090, Size: 6MM X 40MM X 90CM;
14) AB14W060040150, Size: 6MM X 40MM X 150CM;
15) AB14W060060150, Size: 6MM X 60MM X 150CM;
16) AB14W060080150, Size: 6MM X 80MM X 150CM;
17) AB14W060100150, Size: 6MM X 100MM X 150CM;
18) AB14W060120150, Size: 6MM X 120MM X 150CM;
19) AB14W060150150, Size: 6MM X 150MM X 150CM;
20) AB14W060200150, Size: 6MM X 200MM X 150CM;
Balloon Dilatation Catheter
Reason: There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Root cause: Process change control
Recalling firm: ev3 IncType: Catheter, Angioplasty, Peripheral, TransluminalDistribution: Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen.Recall #Z-0904-2025
Open, ClassifiedPosted Jan 15, 2025·Initiated Nov 8, 2024
Cardinal Health Presource Kits:
1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951;
2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952;
3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910;
4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911;
5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912;
6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913;
7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914;
8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951;
9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952;
10) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT953;
11) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT954;
12) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT955;
13) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT956;
14) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT957;
15) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT958;
16) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT959;
17) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95A;
18) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95C;
19) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95F;
20) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95G;
21) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV1;
22) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV2;
23) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVB;
24) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVC;
25) MAXILLO FACIAL PACK,Catalog Number SBA11CMCPD;
26) DIEP PACK,Catalog Number SBA11DPS10;
27) DIEP PACK,Catalog Number SBA11DPS11;
28) DIEP PACK,Catalog Number SBA11DPS12;
29) DIEP PACK,Catalog Number SBA11DPS13;
30) DIEP PACK,Catalog Number SBA11DPS14;
31) DIEP PACK,Catalog Number SBA11DPS15;
32) DIEP PACK,Catalog Number SBA11DPS16;
33) DIEP PACK,Catalog Number SBA11DPS17;
34) DIEP PACK,Catalog Number SBA11DPS18;
35) DIEP PACK,Catalog Number SBA11DPS19;
36) DIEP PACK,Catalog Number SBA11DPS20;
37) DIEP PACK,Catalog Number SBA11DPS21;
38) DIEP PACK,Catalog Number SBA11DPS22;
39) DIEP PACK,Catalog Number SBA11DPSB4;
40) DIEP PACK,Catalog Number SBA11DPSB5;
41) DIEP PACK,Catalog Number SBA11DPSB6;
42) DIEP PACK,Catalog Number SBA11DPSB7;
43) DIEP PACK,Catalog Number SBA11DPSB8;
44) DIEP PACK,Catalog Number SBA11DPSB9;
45) DIEP PACK,Catalog Number SBA11DPSBD;
46) DIEP PACK,Catalog Number SBA11DPSBE;
47) DIEP PACK,Catalog Number SBA11DPSBF;
48) DIEP PACK,Catalog Number SBA11DPSBG;
49) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP1;
50) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP2;
51) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP3;
52) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP4;
53) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP5;
54) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP6;
55) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPB;
56) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPC;
57) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPD;
58) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPE;
59) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH10;
60) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH11;
61) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH12;
62) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH13;
63) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH14;
64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3;
65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4;
66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5;
67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6;
68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7;
69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8;
70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9;
71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB;
72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC;
73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF;
74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG;
75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C;
76) DIEP SIEP PACK,Catalo
Open, ClassifiedPosted Jan 15, 2025·Initiated Nov 8, 2024
Cardinal Health Presource Kits:
1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:;
2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:;
3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:;
4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:;
5 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMP:;
Reason: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Root cause: Nonconforming Material/Component
Recalling firm: Cardinal Health 200, LLCType: Endoscope Introducer KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.Recall #Z-0909-2025 Open, ClassifiedPosted Jan 15, 2025·Initiated Nov 8, 2024
Cardinal Health Presource Kits:
1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1;
2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3;
3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5;
4 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM6;
5 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM7
Reason: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Root cause: Nonconforming Material/Component
Recalling firm: Cardinal Health 200, LLCType: Cardiovascular Procedure KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.Recall #Z-0910-2025 Open, ClassifiedPosted Jan 15, 2025·Initiated Nov 8, 2024
Cardinal Health Presource Kits:
1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE;
2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH;
3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
Reason: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Root cause: Nonconforming Material/Component
Recalling firm: Cardinal Health 200, LLCType: General Purpose Dental TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.Recall #Z-0911-2025 Open, ClassifiedPosted Jan 15, 2025·Initiated Nov 8, 2024
Cardinal Health Presource Kits:
1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ;
2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ;
3 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH4 ;
4 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH5 ;
5 ) STERILE LARYNGOSCOPY PACK, Catalog Number: SEN11LGUHB
Reason: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Root cause: Nonconforming Material/Component
Recalling firm: Cardinal Health 200, LLCType: Laryngoscope KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.Recall #Z-0912-2025 Open, ClassifiedPosted Jan 15, 2025·Initiated Nov 8, 2024
Cardinal Health Presource Kits:
0 ) DESCRIPTION Catalog Number: CATALOG #;
1 ) KIT, NASAL , Catalog Number: PE23NSMEA;
2 ) KIT, NASAL , Catalog Number: PE23NSMEC;
3 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLA;
4 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLC;
5 ) KIT, EAR , Catalog Number: PE30EAGT6;
6 ) KIT, EAR , Catalog Number: PE30EAGT7;
7 ) KIT, EAR , Catalog Number: PE30EAGT8;
8 ) KIT, EAR , Catalog Number: PE30EAGT9;
9 ) KIT, EAR , Catalog Number: PE30EAGTB;
10 ) KIT, EAR , Catalog Number: PE30EAGTC;
11 ) KIT, EAR , Catalog Number: PE30EAGTD;
12 ) KIT, NASAL , Catalog Number: PE35NSB10;
13 ) KIT, NASAL , Catalog Number: PE35NSB11;
14 ) KIT, NASAL , Catalog Number: PE35NSB12;
15 ) KIT, NASAL , Catalog Number: PE35NSB13;
16 ) KIT, NASAL , Catalog Number: PE35NSB14;
17 ) KIT, NASAL , Catalog Number: PE35NSB15;
18 ) KIT, NASAL , Catalog Number: PE35NSB16;
19 ) KIT, NASAL , Catalog Number: PE35NSB17;
20 ) KIT, NASAL , Catalog Number: PE35NSB18;
21 ) KIT NASAL , Catalog Number: PE35NSB19;
22 ) KIT, NASAL , Catalog Number: PE35NSBL1;
23 ) KIT, NASAL , Catalog Number: PE35NSBL2;
24 ) KIT, NASAL , Catalog Number: PE35NSBL3;
25 ) KIT, NASAL , Catalog Number: PE35NSBL4;
26 ) KIT, NASAL , Catalog Number: PE35NSBL5;
27 ) KIT, NASAL , Catalog Number: PE35NSBL6;
28 ) KIT, NASAL , Catalog Number: PE35NSBL7;
29 ) KIT, NASAL , Catalog Number: PE35NSBL8;
30 ) KIT, NASAL , Catalog Number: PE35NSBL9;
31 ) KIT, NASAL , Catalog Number: PE35NSBLA;
32 ) KIT, NASAL , Catalog Number: PE35NSBLB;
33 ) KIT, NASAL , Catalog Number: PE35NSBLC;
34 ) KIT NASAL , Catalog Number: PE35NSBLD;
35 ) KIT, NASAL , Catalog Number: PE35NSBLF;
36 ) KIT, SINUS , Catalog Number: PE3ESKSG1;
37 ) KIT, SINUS , Catalog Number: PE3ESKSG2;
38 ) KIT, SINUS , Catalog Number: PE3ESKSGA;
39 ) KIT, SINUS , Catalog Number: PE3ESKSGB;
40 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU4;
41 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU5;
42 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU6;
43 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU7;
44 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAUH;
45 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAUI;
46 ) KIT, SEPTOPLASTY , Catalog Number: PEDHSPNH3;
47 ) KIT, SEPTOPLASTY , Catalog Number: PEDHSPNHE;
48 ) KIT,ORP MAJOR EAR , Catalog Number: PEHDMJVCG;
49 ) KIT,ENT, SW , Catalog Number: PEMHETMHA;
50 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMH1;
51 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMH2;
52 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHA;
53 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSB10;
54 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSB11;
55 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH4;
56 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH5;
57 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH6;
58 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH7;
59 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH8;
60 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH9;
61 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHP;
62 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHQ;
63 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHR;
64 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL011;
65 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL012;
66 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL01A;
67 ) KIT,NASAL SINUS ,PRESBYTERIAN , Catalog Number: PEV2CL102;
68 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL103;
69 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL104;
70 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL105;
71 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL106;
72 ) KIT,NASAL SINUS , PRESBYTERIAN , C
Open, ClassifiedPosted Jan 15, 2025·Initiated Nov 8, 2024
Cardinal Health Presource Kits:
1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10
2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5
3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6
4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7
5 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH8
6 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH9
7 ) KIT, FETAL SURGERY , Catalog Number PB11FSCHR
Reason: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Root cause: Nonconforming Material/Component
Recalling firm: Cardinal Health 200, LLCType: Gynecological Laparoscopic KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.Recall #Z-0914-2025