Hazard

Sterilization Failure recalls

249 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

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.

51–75 of 249

HighFDA (Devices)·Z-0176-2026·2025-10-22
Medical Surgical Packs Recalled for Improper Sterilization Validation
American Contract Systems Inc. is recalling 32,433 medical surgical kits due to improper sterilization validation. Products were re-sterilized and have not been validated for multiple sterilization cycles.
Product
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0179-2026·2025-10-22
Gynecological surgical convenience kits recalled for unvalidated ethylene oxide re-sterilization
American Contract Systems' gynecological surgical kits were re-sterilized with ethylene oxide after initial sterilization failed. The products were not validated for multiple sterilization cycles, so quality, safety, and effectiveness cannot be confirmed.
Product
Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0180-2026·2025-10-22
Medical Convenience Kits Recalled for Unvalidated Re-sterilization Process
American Contract Systems Inc. is recalling 32,433 medical convenience kits used in angiography procedures because they were re-sterilized after an initial failure without validation for multiple sterilization cycles.
Product
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2608-2025·2025-10-01
Voyant 1-Day Premium Toric Contact Lenses Recalled for Invalid Sterilization
CooperVision is recalling one lot of Voyant 1-Day Premium Toric contact lenses manufactured with an invalid sterilization cycle. Affected lenses are identified by carton lot 20735504301008 and blister lot 6450505898.
Product
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2607-2025·2025-10-01
Sofmed Breathables contact lens recall due to invalid sterilization cycle
CooperVision is recalling one lot of Sofmed Breathables contact lenses due to manufacturing with an invalid sterilization cycle. The affected lenses may not be properly sterilized and could pose a risk to eye health.
Product
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2606-2025·2025-10-01
CooperVision MyDay Toric contact lenses recalled for invalid sterilization
CooperVision is recalling one lot of MyDay Toric contact lenses distributed in four U.S. states. One manufacturing lot was processed with an invalid sterilization cycle, which could affect product sterility.
Product
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2472-2025·2025-09-03
American Contract Systems Surgical Kits Recalled Due to Unconfirmed Sterilization
American Contract Systems is recalling 588 surgical procedure kits distributed in Illinois and Louisiana due to inability to confirm proper sterilization of certain components. The kits may not meet sterilization assurance requirements.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUM
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2470-2025·2025-09-03
Medical Surgery Kits Recalled for Sterilization Assurance Failure
American Contract Systems is recalling 1,094 laparoscopy and pelviscopy procedure kits distributed to Illinois and Louisiana because the company cannot confirm sterilization requirements were met for certain components.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2466-2025·2025-09-03
Medical procedure kits recalled due to unconfirmed sterilization
American Contract Systems is recalling 1,127 medical procedure kits distributed to Illinois and Louisiana because the manufacturer cannot confirm sterilization requirements were met for certain components.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SA
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2465-2025·2025-09-03
American Contract Systems Medical Procedure Kits Recalled Due to Sterilization Assurance Failure
American Contract Systems is recalling 1,233 medical procedure kits distributed in Illinois and Louisiana because the company cannot confirm sterilization requirements were met for certain components.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2467-2025·2025-09-03
Medical Procedure Kits Recalled Due to Unconfirmed Sterilization
American Contract Systems is recalling 6,617 medical procedure kits because the company cannot confirm sterilization requirements were met. The affected kits were distributed to healthcare facilities in Illinois and Louisiana.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2464-2025·2025-09-03
Cardiac and Vascular Surgical Procedure Kits Recalled for Sterilization Assurance Issues
American Contract Systems is recalling 31,506 surgical procedure kits due to inability to confirm sterilization assurance. An internal investigation found that certain components may not have been properly sterilized.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, M
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2469-2025·2025-09-03
Obstetric procedure kits recalled due to unconfirmed sterilization assurance
American Contract Systems is recalling 781 medical procedure kits because the manufacturer cannot confirm sterilization was properly completed. The affected kits were distributed to healthcare facilities in Illinois and Louisiana.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2260-2025·2025-08-13
Robotic Partial Nephrectomy Kit Recalled for Sterilization Integrity Issue
AVID Medical is recalling 46 robotic partial nephrectomy surgery kits due to inadvertent re-sterilization of the visualization system component, which caused discoloration.
Product
PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1954-2025·2025-06-18
Tecfen Medical Ophthalmic Knives Recalled for Sterility Assurance
Tecfen Medical is recalling 2.0mm Crescent Knife surgical instruments (Model QKN1010, Lot ZGY24071501-03) due to sterility assurance concerns. The affected devices were distributed worldwide to medical facilities.
Product
Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent kn
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1339-2025·2025-03-26
Open Heart Surgery Kit Sterilization Assurance Cannot Be Confirmed
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.
Product
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1358-2025·2025-03-26
Vascular Pack Sterilization Assurance Requirements Cannot Be Confirmed
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.
Product
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1359-2025·2025-03-26
Cardiac Surgical Training Kits Recalled for Sterilization Verification Failure
American Contract Systems Inc is recalling OPEN HEART A PACK surgical training kits (Models UTOH19AI, UTOH19AJ-01, UTOH19AJ-02) because sterilization assurance requirements cannot be confirmed. Lack of sterilization could impair functionality.
Product
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1353-2025·2025-03-26
Medical Pump Kits Recalled for Unconfirmed Sterilization and Functionality Loss
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.
Product
CV BASIC PUMP PACK , Model No WECV23D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1336-2025·2025-03-26
C-Section Surgical Packs Recalled Over Sterilization Assurance Failure
American Contract Systems is recalling C-Section surgical packs (252 kits) after being unable to confirm sterilization assurance. Lack of verified sterilization could delay or prolong surgical treatment.
Product
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1335-2025·2025-03-26
Cystoscopy Kit Recalled for Sterilization Assurance Verification Failure
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.
Product
CYSTO PACK , Model N. HKCY31A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1340-2025·2025-03-26
General Angio Pack Sterilization Assurance Cannot Be Confirmed
American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.
Product
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1345-2025·2025-03-26
FDA Recalls URO Robotic Pack Surgical Kit Due to Sterilization Concerns
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.
Product
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1342-2025·2025-03-26
Surgical Positioning Device Recalled for Unconfirmed Sterilization Assurance
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.
Product
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1346-2025·2025-03-26
CYSTO Model SACY80R Recall for Sterilization Assurance Failure
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.
Product
CYSTO , Model No SACY80R
Category
Medical Device
Distribution
Distributed nationwide