Hazard
471 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 471 sterility breach recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (6%) 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 breach 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.
The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.
The FDA is recalling Vistec X-Ray Detectable Sponges because a breach in the packaging barrier may have compromised their sterility.
Zimmer Manufacturing B.V. is recalling specific lots of VersaFx Femoral Fixation System screws because a small hole may be present in the inner tray, potentially compromising sterility.
Zimmer Manufacturing B.V. is recalling 49 units of sterile I/B II Knee Fluted Rods due to insufficient sealer calibration data.
Zimmer Manufacturing B.V. is recalling NexGen Option Stemmed Tibia components due to insufficient sealer calibration data, raising concerns about the sterility of the devices.
Zimmer Manufacturing B.V. is recalling NexGen All-Poly Patella implants due to insufficient sealer calibration data affecting sterility.
Stryker is recalling AccuPlace Straight Level Needle Guides because packaging defects may compromise sterility. The recall affects 5,800 units distributed nationwide.
Stryker is recalling AccuPlace Round Level Needle Guides because packaging defects may compromise sterility. The recall affects 5,800 units distributed nationwide.
Stryker is recalling AccuPlace Drace Stereotaxic Needle Guides because packaging defects may breach sterility. The recall covers 5,800 units distributed nationwide.
Stryker is recalling 5,800 AccuPlace Drace Stereotaxic Needle Guides due to a potential breach in sterility caused by packaging damage.
Medtronic is recalling 496 Perfusion Tubing Packs due to a potential breach in the header bag seal. The affected lots were distributed nationwide in the US.
Medtronic is recalling 64 units of Achieve Electrical Cables (Model 990066) due to a potential sterility breach. The sterile, single-use cables were distributed to facilities in 16 states and DC.
Olympus is recalling MAJ-1606 Instrument Channel Adaptors due to small puncture marks in sterile packaging that may compromise sterility.
Intuitive Surgical is recalling 1,200 Fluorescence Imaging Procedure Kits because shipping damage may have compromised the sterile packaging of the stopcocks.
Stryker is recalling Woundcare Replacement Kits used for wound debridement due to a potential sterility breach in the packaging.
Zimmer, Inc. is recalling 352 Natural Knee II Revision Femoral Stems because a breach in the sterile barrier could lead to periprosthetic infection.
DeRoyal Industries is recalling custom surgical kits containing Medtronic Devon Light Gloves due to splits or holes.
Vidacare Corporation is recalling T.A.L.O.N intraosseous needles due to a potential breach in sterility. The recall affects 2,104 boxes distributed in the US and internationally.
The FDA is recalling VenaSeal vascular closure systems because a possible sterility breach in the outer packaging may compromise the device's sterility.
Stryker Instruments is voluntarily recalling Ambulating Bulbs used with wound drains because of a potential sterility breach in the packaging.
Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.
Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.
Stryker Instruments is voluntarily recalling specific trocar wound drains and ambulating bulbs because of a potential sterility breach in the packaging.
Stryker Instruments is voluntarily recalling specific wound drain devices because of a potential sterility breach in the packaging.
Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.