Hazard
574 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 574 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 34 (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 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.
American Contract Systems Inc is recalling C-Section PPS positioning systems due to inability to confirm sterilization assurance requirements were met. The failure could lead to loss of functionality and delayed treatment.
American Contract Systems Inc recalls HIP SCOPE orthopedic surgical kits due to inability to confirm sterilization assurance requirements were met. Unsterilized instruments could increase infection risk during surgical procedures.
American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.
American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.
American Contract Systems Inc is recalling 106 SPINE LUMBAR PACK kits (Models UTSL72AA, UTSL72AB) because the manufacturer cannot confirm sterilization assurance requirements were met, potentially causing functionality loss and treatment delays.
American Contract Systems Inc is recalling 170 Diagnostic Neuro IR Tray kits due to inability to confirm sterilization assurance requirements were met. The units may lose functionality and cause treatment delays.
American Contract Systems Inc is recalling 630 laparoscopy pack kits due to unconfirmed sterilization assurance. This could cause loss of functionality and treatment delays.
American Contract Systems is recalling 725 Labor & Delivery Packs because the manufacturer cannot confirm sterilization requirements were met. Devices may lack functionality and could delay or prolong patient treatment.
American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.
American Contract Systems Inc is recalling 134 CV Basic Pump Pack kits because the manufacturer cannot confirm sterilization requirements were met. Possible loss of functionality could delay or prolong patient treatment.
American Contract Systems is recalling PICC line catheters because sterilization assurance requirements could not be confirmed. Unsterilized devices may lose functionality and delay patient treatment.
American Contract Systems Inc is recalling CYSTO PACK cystoscopy kits because the company cannot confirm sterilization assurance requirements were met. Possible loss of functionality could delay or prolong patient treatment.
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.
American Contract Systems Inc recalls 41 URO Robotic Pack surgical kits distributed in Ohio because sterilization assurance requirements could not be confirmed. Non-sterile equipment may lead to delayed treatment.
American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.
American Contract Systems Inc is recalling Delivery Pack medical devices (Models SGDV22D-01 and SGDV22E) because sterilization assurance requirements were not confirmed. Unsterilized devices may not function properly and could delay treatment.
American Contract Systems Inc is recalling 17 MAJOR DIEP surgical kits because sterilization assurance requirements cannot be confirmed. This creates a risk of device malfunction and treatment delays.
American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.
Karl Storz Endoscopy is recalling 285 units of optical biopsy and grasping forceps (REF 723400) distributed across 31 US states due to failure of manual cleaning validation, which compromises sterility assurance.
Folsom Metal Products recalls 42 sets of DKS Disposable Kerrison System surgical instruments inadvertently distributed without commercial distribution approval. Four units were not sterilized.
American Contract Systems is recalling 12 Open Shoulder medical convenience kits because a faulty chart recorder prevented verification of sterilization requirements.
American Contract Systems, Inc. is recalling the Hand Pack AKHD97C medical convenience kit because an inoperable chart recorder caused humidity readings to fall outside specifications, preventing confirmation of sterilization assurance.
American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.
American Contract Systems is recalling 66 ENT medical convenience kits because humidity readings were out of specification, preventing confirmation of sterilization.