Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline convenience kits:
20CM CVC INSERTION KIT
ECVC6805B
2L 8.5FR 16CM CVC INSERTION KIT
ECVC8055A
VANTEX PI CVC 7F, 3L, 20CM BUNDLE
ECVC6915A
ECVC6985B
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: General Surgery TrayDistribution: US Nationwide distribution. OUS distribution pending.Recall #Z-2439-2026
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline convenience kits:
DRIVELINE MANAGEMENT KIT
EBSI1688
PORT DRESSING CHANGE KIT
EBSI1328A
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: General Surgery TrayDistribution: US Nationwide distribution. OUS distribution pending.Recall #Z-2440-2026
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline convenience kits:
ACL PACK
DYNJ64161C
ARTHROSCOPY PACK
DYNJ47103D
DYNJ67197G
DYNJ85197A
DYNJT4007
BASIC ACCESS PACK-LF
DYNJ36698B
BASIC BACK TRAY
DYNJ89037
BASIC PEDI PACK-LF
DYNJ0171446I
DYNJ0171446J
BASIC SPINE
DYNJ910915A
BREAST PACK
DYNJ87587A
BREAST PLASTIC PACK
DYNJ84482C
C SECTION
DYNJ49172I
CAROTID ENDARTERECTOMY PACK
DYNJ48013L
CENTRAL LINE PACK-LF
DYNJ0220136S
CERVICAL FUSION
DYNJ908135B
CERVICAL SPINE PACK
DYNJ53044G
C-SECTION
DYNJ909099F
DAVINCI PROSTATE PACK
DYNJ61711C
DEPAUL FOOT & ANKLE-LF
DYNJ20010L
DIEP PACK
DYNJ64964J
DYNJ43210K
DYNJ61787F
DYNJ87065
EAR CUSTOM PACK
DYNJ82564A
ENT FREE FLAP PACK SAFETY
DYNJ54720D
EP PACEMAKER SAFETY #1
DYNJ54722F
EPCH EXTREMITY PACK
DYNJ83095B
EXTREMITY PACK
DYNJ32934F
EXTREMITY PACK-LF
DYNJ68935B
FISTULA PACK
DYNJ66502B
GENDER AFFIRMING SURGERY
DYNJ66252F
GYN LAPAROSCOPY PACK AHSC
DYNJT8381
HAND PACK WATCHMAKER-LF
DYNJ34580D
HEAD & NECK PACK-LF
DYNJ0282388T
DYNJ88308
HIP SCOPE
DYNJ907120D
KNEE ARTHRO PACK
DYNJ58404F
KNEE ARTHROSCOPY PACK
DYNJ84740A
LAMI OVERHEAD PACK
DYNJ46531Q
LAMINECTOMY NEURO MPH
DYNJT5271
LAMINECTOMY PACK
DYNJ68785D
LAP APPY PACK
DYNJT6005
LAP CHOLE PACK
DYNJ82087A
LEVY PACK
DYNJ83939C
MAJOR LAP VCH
DYNJ39217P
MAJOR NEURO PACK-LF
DYNJ0578916AA
MAJOR PACK
DYNJ58528J
MINOR GEN PACK
DYNJ61661B
MINOR LAPAROTOMY PACK-LF
DYNJ0753436P
MINOR PACK
DYNJ54968B
NEURO PACK
DYNJ67628D
NEURO SHUNT PACK-LF
DYNJ0578815W
OMFS PACK
DYNJ54400C
OPEN HEART PACK
DYNJT5008
OPEN HEART-LF
DYNJ48260F
OPEN LAPAROTOMY PACK
DYNJ39247I
DYNJ39247J
PACEMAKER PACK
DYNJ31461I
DYNJ61411C
PACK,ORTHO FLIP
DYNJ65471B
PED OPEN HEART PACK
DYNJ45373G
PLASTIC PACK
DYNJ82495D
PLASTICS PK - NO SYR
DYNJ62433F
PODIATRY PACK
OP7809M
PPE BUNDLE KIT
DT13351A
PROSTATE ROBOTIC PACK
DYNJ84120C
RADIAL ART LINE INSERTION
ARTNC234
ROBOTIC GENERAL WHH
DYNJT5376
ROBOTIC PACK
DYNJ47978G
RR-SPINE PACK
DYNJ62643B
SHOULDER ARTH PACK
DYNJ58410D
SHOULDER ARTHROSCOPY PACK
DYNJ54477C
DYNJT8391
SHOULDER PACK
DYNJ61052B
DYNJT3266
SHOULDER PACK-LF
DYNJ0122428K
PHS656414I
SPINE PACK
DYNJ64949C
DYNJ83649B
SPINE SHOULDER PACK
DYNJ47104D
STERILE ACCESS KIT
DYNDA2664
TOTAL KNEE PACK
DYNJ84741B
TUBAL PACK
DYNJ68253F
UNIVERSAL PACK
DYNJ83246B
VA TAMPA GENERAL ROBOTIC PACK
DYNJT6993
W.C. MINOR LAPAROTOMY PK-LF
DYNJ0509186J
ZALE OTOLOGY CDS
CDS983181G
Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Process control
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline convenience kits:
FEMORAL BLOCK TRAY
DYNJRA1739B
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-2442-2026
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline convenience kits:
PORT A CATH
DYNJ906818A
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-2443-2026
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline convenience kits:
BIB AV FISTULA PACK
DYNJ58304B
CARDIAC MINOR SURGICOUNT PACK
DYNJ56573B
ENDOVASCULAR PACK
DYNJ29135N
EP DEVICE
DYNJ65916B
FULL LINE ANEURYSM CDS
CDS983672P
GEN FEM POP #14-RF
DYNJ21877W
IMPLANT PACK
DYNJ39316D
OPEN HEART MRNGSD
DYNJ58354F
PACEMAKER PACK-LF
DYNJ0618174N
PACEMAKER SETUP PACK
DYNJ35761D
PACER / CATH LAB PACK-LF
DYNJ0972604A
PACER CDS
CDS983686I
PACER PACK
DYNJ52059D
PK, EP LAB PACEMAKER
DYNJ43663A
VENOUS ACCESS PACK
DYNJ45640B
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-2444-2026
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline convenience kits:
ADD-A-CATH ARTERIAL INSERTION
ARTNC185
PED SCHOOL AGE PICC DRSG TRAY
DYNDC3291
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: Central Venous Catheter TrayDistribution: US Nationwide distribution. OUS distribution pending.Recall #Z-2445-2026
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline convenience kits:
C SECTION
CDS985505G
C SECTION PACK
DYNJ68260D
C-SECTION
DYNJ905094B
C-SECTION RECOVERY #2
CDS820091P
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: Cesarean Section TrayDistribution: US Nationwide distribution. OUS distribution pending.Recall #Z-2446-2026
Open, ClassifiedPosted Jun 12, 2026·Initiated Apr 27, 2026
Medline convenience kits:
HYSTERECTOMY PACK-LF
DYNJ20485L
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: Hysterectomy KitDistribution: US Nationwide distribution. OUS distribution pending.Recall #Z-2447-2026
Open, ClassifiedPosted Jun 11, 2026·Initiated Apr 15, 2026
Fresh Roast Systems ColorTrack.
Model Name: ColorTrack. Model Number: BENCH R-100
Reason: A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Fresh Roast Systems IncType: General Purpose Laser ProductsDistribution: U.S.Recall #Z-2280-2026
Open, ClassifiedPosted Jun 11, 2026·Initiated May 7, 2026
Bicarby Dialysate; Model number: RFP-400-G;
Reason: There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
Root cause: Process control
Recalling firm: Fresenius Medical Care Holdings, Inc.Type: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)Distribution: Domestic: TX.Recall #Z-2401-2026
Open, ClassifiedPosted Jun 11, 2026·Initiated Apr 29, 2026
Boston Scientific CSK Electrodes:
REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm)
REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm);
REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm);
REF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 15 cm x 28 ga (0.36 mm)
REF: CSK-TC20, CSK Electrode, STAINLESS STEEL, 20 cm x 28 ga (0.36 mm)
REF: CSK-TC5,CSK Electrode, STAINLESS STEEL, 5 cm x 28 ga (0.36 mm);
REF: CSK-TC5-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 5 cm x 28 ga (0.36 mm)
Reason: Reusable electrodes may not meet expected performance levels.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific Neuromodulation CorporationType: Probe, Radiofrequency LesionDistribution: Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.Recall #Z-2402-2026
Open, ClassifiedPosted Jun 11, 2026·Initiated Apr 29, 2026
Boston Scientific TCN Electrodes:
REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in);
REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in)
REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in);
REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45 mm (0.0175 in)
REF: TCN-5-3m, TCN Electrode, NITINOL, 3M CABLE, 5 cm x 0.45 mm (0.0175 in)
REF: TCN-10-3M, TCN Electrode, NITINOL, 3M CABLE, 10 cm x 0.45 mm (0.0175 in);
REF: TCN-15-3M, TCN Electrode, NITINOL, 3M CABLE, 15 cm x 0.45 mm (0.0175 in)
REF: TCN-20-3M, TCN Electrode, NITINOL, 3M CABLE, 20 cm x 0.45 mm (0.0175 in)
Reason: Reusable electrodes may not meet expected performance levels.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific Neuromodulation CorporationType: Probe, Radiofrequency LesionDistribution: Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.Recall #Z-2403-2026
Open, ClassifiedPosted Jun 11, 2026·Initiated Apr 29, 2026
Boston Scientific Model SC-4318, Clik X Anchor
REF: M365SC43180
Reason: Sterile anchors my lack sterility assurance.
Root cause: Packaging process control
Recalling firm: Boston Scientific Neuromodulation CorporationType: Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefDistribution: US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.Recall #Z-2404-2026
Open, ClassifiedPosted Jun 11, 2026·Initiated May 12, 2026
Merlin" Patient Care System (PCS) software
Merlin" PCS 3650 programmer Model 3330 software
Reason: Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Root cause: Software Design Change
Recalling firm: Abbott MedicalType: Leadless PacemakerDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: Not provided yetRecall #Z-2405-2026
Open, ClassifiedPosted Jun 11, 2026·Initiated May 21, 2026
MOSAIQ Oncology Information System
Reason: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Root cause: Software design
Recalling firm: Elekta, Inc.Type: Accelerator, Linear, MedicalDistribution: Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY, NJ, KS, FL, IA, NM, TX and the countries of Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Pakistan, Panama, Poland, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.Recall #Z-2406-2026
Open, ClassifiedPosted Jun 11, 2026·Initiated Apr 30, 2026
Halyard, Pain Pack. Kit Code: AMPK48-01.
Reason: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Root cause: Process control
Recalling firm: AVID Medical, Inc.Type: Orthopedic TrayDistribution: US Nationwide distribution in the state of Iowa.Recall #Z-2407-2026
Open, ClassifiedPosted Jun 11, 2026·Initiated Apr 30, 2026
Halyard, Towel Six Pack. Kit Code: AMTS70-01.
Reason: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Root cause: Process control
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the state of Iowa.Recall #Z-2408-2026
Open, ClassifiedPosted Jun 11, 2026·Initiated Apr 30, 2026
Halyard, Drape Pack. Kit Code: LMDP36-01.
Reason: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Root cause: Process control
Recalling firm: AVID Medical, Inc.Type: Orthopedic TrayDistribution: US Nationwide distribution in the state of Iowa.Recall #Z-2409-2026
Open, ClassifiedPosted Jun 11, 2026·Initiated Apr 30, 2026
Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
Reason: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Root cause: Process control
Recalling firm: AVID Medical, Inc.Type: Orthopedic TrayDistribution: US Nationwide distribution in the state of Iowa.Recall #Z-2410-2026