Hazard
2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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 compromise 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.
Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent Systems due to seal defects in product packaging that could compromise sterility. Affected lot B644679 had national distribution.
Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.
Integra LifeSciences is recalling 1,639 units of its Cranial Access Kits because the outer packaging may split without additional external force, potentially compromising device sterility.
Integra LifeSciences recalled the Integra Cranial Access Kit (160 units) due to a defect in the outer packaging that can split and compromise device sterility, creating an infection risk for neurosurgical procedures.
Integra LifeSciences is recalling 510 units of Cranial Access Kits due to a defect in outer packaging that can split spontaneously, compromising device sterility and increasing infection risk in neurosurgery.
Integra LifeSciences is recalling a cranial access kit due to a packaging defect that can cause the sterile outer packaging to split without additional force, potentially compromising device sterility.
Integra LifeSciences is recalling 485 Cranial Access Kits (Catalog INS7250) due to a packaging defect that can cause spontaneous splitting, compromising device sterility. The kits are used for surgical access to the brain.
Integra LifeSciences Corp. is recalling 173 units of its Cranial Access Kit due to a packaging defect that can split and compromise device sterility. No illnesses have been reported.
Integra LifeSciences is recalling 180 Cranial Access Kits due to a packaging defect that can cause splits, compromising the sterility of the surgical device.
Integra LifeSciences is recalling 59 Integra Cranial Access Kits due to outer packaging that can split without external force, compromising device sterility. Affected units (Lot 6837706, exp. 1-Mar-25) should be discontinued immediately.
Integra LifeSciences is recalling the Integra Cranial Access Kit due to a defect in the outer packaging that can split and compromise device sterility. A total of 173 units are affected.
B.Braun NORM-JECT Luer Lock Solo 10ml sterile syringes are being recalled because the sterile blister packaging may be damaged, potentially compromising sterility. The recall affects 604,800 units distributed nationwide.
B. Braun NORM-JECT Luer Solo 10 ml sterile syringes are recalled because blister packaging may be damaged, potentially compromising sterility. Approximately 534,000 units are affected; lot numbers 22M28C8 and 23A09C8 are included.
Medline is recalling 324,451 sterile iris scissors because the tip protector may detach, exposing a sharp point that could puncture sterile packaging and compromise instrument sterility.
Cook Vandergrift is recalling approximately 15,951 Cook Lead Clipper devices due to potential sterility compromise from packaging seal breaches. The surgical tool is used for cardiac lead retrieval procedures.
Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The recall affects 22,112 bags nationwide.
Medicrea International is recalling 4,489 IMPIX MANTA intervertebral fusion devices due to potential pinholes in product packaging that could compromise device sterility.
Medicrea International is recalling IMPIX DLIF intervertebral fusion devices due to potential pinholes in product packaging that could compromise sterility.
Medicrea is recalling IMPIX C+ cervical intervertebral fusion devices due to a potential packaging non-conformity that presents as a pinhole in the product pouch. The defect could affect product integrity for this implantable device.
Medline is recalling approximately 189,221 surgical scissors because they were manufactured without a tip protector, allowing them to break through sterile packaging and compromise product sterility.
Medline is recalling probe cover kits with ultrasound gel due to inadequate barriers at the seams that may compromise sterility during diagnostic ultrasound procedures.
Medline probe cover kits used in ultrasound-guided medical procedures may have inadequate barriers at the seams, posing a contamination risk. Approximately 270,000 units distributed worldwide since December 2017 are affected.
Medline is recalling 2739 units of probe cover kits used in diagnostic ultrasound and catheter insertion procedures due to inadequate barriers at seams that could compromise sterility.
DeRoyal Industries is recalling 328 surgical procedure packs because outer package seals could be open or compromised, affecting product sterility. The affected packs are used in operating rooms nationwide.
DeRoyal Industries is recalling 40 units of STURDI STRAINER TRAY STANDARD procedure packs nationwide due to potentially compromised outer package seals that could affect sterility.