Hazard
663 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 663 sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 261 (39%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility assurance recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Arrow Biopsy System Comprehensive Kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 14,840 units affected.
Arrow PICC and PICC/Delta kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 3,481 units affected.
Arrow central venous catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 35,540 units are affected.
Arrow access trays and StimuCath safety kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 205,685 units affected.
The Arrow PI Midline two-lumen 5 Fr x 20 cm kit is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 90 units affected.
The Arrow Access Tray, REF ASK-04001-MC3, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 8,265 units affected.
Arrow PI JACC and AGBA PI JACC catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,516 units affected.
Arrow two-lumen hemodialysis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,425 units affected.
The Arrow peritoneal lavage catheter kit, 8 Fr, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 7,560 units affected.
Arrow paracentesis kits, REF AK-00376 and ASK-00376-VCU, are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 50,724 units affected.
Arrow radial artery catheter and arterial line kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 785,999 units affected.
The Arrow paracentesis kit, REF ASK-00376-JHH, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 180 units affected.
Arrow access trays and PSI kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 426,041 units are affected.
Arrow hemodialysis and AHDC catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 62,719 units affected.
Halyard Eye Bag Packs, kit code UIEB48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 60 kits affected.
Boston Scientific Clik X Anchors, model SC-4318, are being recalled because the sterile anchors may lack sterility assurance. 43 units are affected.
Halyard Drape Packs, kit code LMDP36-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 72 kits affected.
Halyard Pain Packs, kit code AMPK48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 120 kits affected.
Halyard Towel Six Packs, kit code AMTS70-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 224 kits affected.
Lidocaine HCl Injection USP in 5 mL single-dose ampules distributed by Spectra Medical Devices is being recalled for lack of assurance of sterility. 210,625 ampules affected.
UCB Biosciences is recalling CIMZIA (certolizumab pegol) prefilled syringes nationwide because of a lack of assurance of sterility. Affected lots are distributed across the US.
Medline Industries is recalling multiple convenience kit models due to calibration issues with equipment used to sterilize and package the devices, which could affect sterility assurance levels.
Medline Industries is recalling six models of medical device convenience kits due to calibration issues with sterilization and packaging equipment that may have reduced sterility assurance levels. The recall affects 553 units distributed nationwide.
Medline Industries is recalling approximately 29,192 labor and delivery kits and OB packs due to calibration issues in sterilization equipment that may impact sterility assurance. The products were exposed to validated sterilization cycles, but the calibration problems potentially compromise sterile status.
Medline Industries is recalling three models of medical trays due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects LVAD Driveline Trays and Central Line Dressing Change Trays distributed nationwide.