Hazard
664 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 664 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 262 (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.
SI-BONE, Inc. is recalling 100 units of iFuse TORQ Implant System screws because packaging seal integrity testing failed, preventing assurance of sterility.
Arrowhead DE LLC is recalling 4,171 Arrow-LOK Implants because they did not undergo a required gamma radiation dose audit, which could reduce sterility assurance and lead to patient infection.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators nationwide because affected units may have open or incomplete seals on the packaging, which could compromise sterility assurance.
Somerset Therapeutics is recalling Pemetrexed for Injection 100mg/Vial due to lack of sterility assurance. The recall affects approximately 12,000 vials distributed nationwide.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, lacking sterility assurance.
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.
Arrow epidural catheter and catheterization kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,525,831 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. 37,738 units are affected.
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 radial and arterial catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 310,606 units affected.
Arrow AGBA PICC G4 Stylet kits and VPS access kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 11,358 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 PI CVC kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall.
Arrow access trays and multilumen PI CVC kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,061,069 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 spinal anesthesia kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 79,614 units are 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 radial artery, arterial line and hydrophilic catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall.
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.
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 arterial line, radial artery and vessel catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall.
A further group of Arrow PSI kits is being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 72,354 units are affected.
Arrow PSI and PSI/CVC kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 348,684 units are affected.
Arrow midline catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 177,014 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.