Hazard
580 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 580 sterilization failure recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 38 (7%) 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 sterilization failure 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.
Covidien is recalling Situate Laparotomy Sponges because some packs may contain improperly sterilized units lacking required RF detection features. Non-sterile sponges could cause infection, tissue trauma, and sepsis during surgery.
Synthes recalls 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails (5 units) due to failed sterilization. These surgical implants were distributed worldwide and pose infection risk if implanted.
Paragon 28 is recalling Phantom TTC Nails distributed before sterilization. Non-sterile surgical devices pose a potential infection risk if implanted.
Synthes is recalling 30 Opal intervertebral cage spinal implants (Lot 427P153) because sterility cannot be confirmed. Patients with these devices should contact their surgeon immediately.
Paragon 28 has recalled the Phantom TTC Nail (11.5 X 250mm, RIGHT, REF: P31-615-250R) distributed in California prior to sterilization. Non-sterilized surgical implants pose a risk of infection.
Synthes (USA) Products LLC is recalling 11 TFNA Femoral Nails (Lot 3744P37) because the products are not sterilized or sterility cannot be confirmed, posing infection risk.
American Contract Systems is recalling 7,881 surgical procedure kits nationwide because components were sterilized without proper validation, risking loss of functionality or elevated chemical residue.
American Contract Systems, Inc. recalls surgical convenience kits whose added components may lack proper sterilization validation, potentially resulting in loss of functionality or retained sterilant residue.
American Contract Systems is recalling 804 custom ear, nose and throat surgical kits nationwide because components were sterilized without validation that they could tolerate the process, potentially affecting functionality or drug efficacy.
American Contract Systems recalled 144 custom OB/GYN procedural kits after discovering components were sterilized without proper documentation, potentially losing functionality or efficacy. Affected units were distributed nationwide.
American Contract Systems is recalling 12,291 cardiac procedure kits nationwide. Components were exposed to sterilization without documented assessment of suitability, potentially causing loss of functionality or efficacy.
Atrium Oasis surgical drain recalled due to sterilization nonconformance that shortened the product's shelf life. Affected units were distributed nationwide and may not maintain sterility if used after November 17, 2025.
Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.
Atrium Medical Corporation is recalling 2,460 units of the Atrium Firm PVC Thoracic Catheter 36FR Straight due to sterilization nonconformance that caused premature product aging and inaccurate expiration dating. Facilities in 14 U.S. states are affected.
Aizu Olympus is recalling 24 colonoscopes with defective repairs to the light guide connector. The defect may prevent proper imaging, reduce suction, and impair device cleaning, potentially exposing patients to contamination.
Aizu Olympus choleodochoscopes with unvalidated air drying processes may retain water in the channel after repair, risking microbial contamination and patient infection. Affected models: CHF-BP30, CHF-CB30L, CHF-P60.
Olympus Corporation is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope nationwide due to sterilization failures that may occur when devices are reprocessed without adequate drying time in the endoscope channel.
American Contract Systems recalled 1260 units of Cath Cardiac Pack due to improper sterilization exposure that may cause loss of functionality or higher ethylene oxide residuals.
Moody Dunbar Inc recalls HEB and Sysco brand sweet potatoes because a sterilization monitoring chart malfunctioned during production, preventing verification of adequate heat treatment.
Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially revision surgery.
Encore Medical is recalling 15 orthopedic implants (DJO Surgical Altivate Reverse) due to sterilization failure. If implanted, unsterilized components may cause infection requiring treatment, monitoring, or revision surgery.
Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.
DJO Surgical orthopedic implants (lot 878B1171) were shipped without sterilization and may cause infection if implanted, potentially requiring treatment, monitoring, or revision surgery. Contact your healthcare provider to verify your lot number.
Reverse shoulder implant components were shipped without final sterilization, potentially leading to infection and possible revision surgery if implanted. Encore Medical is recalling 64 units distributed across the US and internationally.
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of validated sterilization processes used during its manufacture.