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.

176–200 of 249

HighFDA (Devices)·Z-0218-2023·2022-11-23
CareFusion GENESIS Sterilization Containers Recalled for Inadequate Aerosol Challenge Testing
Carefusion 2200 Inc is recalling 562 Genesis STERRAD reusable sterilization containers due to failure to consistently meet aerosol challenge testing requirements, used to sterilize surgical instruments in healthcare facilities.
Product
CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1791-2022·2022-10-05
Sterilization Roll Recalled Due to Temperature Exposure During Manufacturing
SPS Medical Supply Crosstex sterilization rolls (model SCT3) are being recalled because they were exposed to high temperatures during manufacturing facility storage before shipment. Temperature exposure may have compromised the product's sterilization effectiveness.
Product
SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT3.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1793-2022·2022-10-05
STERIS Sterilization Indicators Recalled Due to Temperature Excursions
Six sterilization monitoring devices from STERIS Corporation were recalled due to temperature excursions during storage and delivery that may have compromised their effectiveness. Affected products were distributed nationwide between June and September 2021.
Product
a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/4 Inch Model Number: PCC006. c. STERIS CORP VERIFY Verify Sterilization Biol
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1696-2022·2022-09-14
Port Insertion Packs Recalled Due to Unvalidated Sterilization
American Contract Systems is recalling Various Port Insertion Packs that were exposed to multiple sterilization cycles without proper validation. The devices may not meet sterility standards.
Product
Various Port Insertion Packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1692-2022·2022-09-14
PICC and Central Line Packs Exposed to Unvalidated Sterilization Cycles
American Contract Systems is recalling PICC line and central line packs due to exposure to multiple sterilization cycles without validation. Two units were distributed to healthcare facilities in 13 U.S. states.
Product
Various PICC Line, Central Line Packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1699-2022·2022-09-14
Surgical instrument convenience packs recalled for inadequate sterilization validation
American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.
Product
Various convenience packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1693-2022·2022-09-14
ENT Surgical Packs Recalled Due to Sterilization Validation Failure
American Contract Systems recalls various ENT surgical packs that may not have been properly sterilized due to multiple sterilization cycles without adequate validation. The packs were distributed to healthcare facilities in 13 states.
Product
Various ENT Packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1689-2022·2022-09-14
Angiography Packs Recalled Due to Sterilization Validation Failure
American Contract Systems, Inc. is recalling 57 angiography packs and trays that were exposed to multiple sterilization cycles without proper validation for repeated sterilization exposure.
Product
Various Angiography packs/trays
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1695-2022·2022-09-14
Cysto Packs Recalled Due to Inadequate Sterilization Validation
American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.
Product
Various Cysto Packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1690-2022·2022-09-14
Angiography and Catheterization Packs Recalled Due to Inadequate Sterilization Validation
American Contract Systems is recalling 61 angiography and catheterization packs that were exposed to multiple sterilization cycles without proper validation. The affected packs were distributed to healthcare facilities in 13 U.S. states.
Product
Various Angiography/Cath Lab packs/trays
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1698-2022·2022-09-14
Medical device convenience packs exposed to unvalidated sterilization cycles
American Contract Systems, Inc. is recalling 116 convenience packs distributed to U.S. health systems and distributors in 13 states because they were exposed to multiple sterilization cycles without validation, potentially compromising device sterility assurance.
Product
Various convenience packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1704-2022·2022-09-14
D&C Pack Recall Due to Sterilization Validation Failure
American Contract Systems is recalling D&C packs that were exposed to multiple sterilization cycles without proper validation. The sterilization failure may compromise device sterility.
Product
D&C pack
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1697-2022·2022-09-14
Breast Abdominoplasty Pack Recalled for Inadequate Sterilization Cycle Validation
American Contract Systems, Inc. is recalling Breast Abdominoplasty Packs that were exposed to multiple sterilization cycles without validation that the process could safely maintain instrument sterility through repeated exposures.
Product
Breast Abdominoplasty Pack
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1694-2022·2022-09-14
Laparoscopy surgical instrument packs recalled for sterilization validation failure
American Contract Systems is recalling 39 laparoscopy instrument packs that were exposed to multiple sterilization cycles without validation. The sterilization process was not tested for repeated exposures.
Product
Various Laparoscopy Packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1700-2022·2022-09-14
Neurology Surgical Packs Recalled for Sterilization Validation Failure
American Contract Systems recalls 37 units of neurology surgical packs distributed across 13 US states due to exposure to multiple sterilization cycles without proper validation.
Product
Various neurology packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1270-2022·2022-06-22
Philips OmniWire guide wire recalled for potential sterilization failure
Volcano Corp is recalling 11 Philips OmniWire Pressure guide wires distributed in Washington, Wisconsin, and Canada due to a potential failed sterilization process.
Product
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1216-2022·2022-06-08
Ratcheting Screwdriver Handle in Surgical Kit Unable to Meet Sterilization Requirements
Tornier's Ratcheting Screwdriver Handle in the Aequalis Perform Reversed kit cannot meet sterilization requirements when sterilized per instructions in an Aesculap container. The company is recalling 1066 units distributed nationwide.
Product
Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1170-2022·2022-06-08
Sterile Epidural Tray Recalled Due to Validation Uncertainty
Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.
Product
Sterile Epidural Tray Catalog Number: 6259R2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1166-2022·2022-06-08
FDA Recalls CVC Dressing Change Kit Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling CVC Dressing Change Kits nationwide due to uncertainty about test method validation during manufacturing. Affected swab products may not have been adequately validated for sterility and efficacy.
Product
CVC Dressing Change Kit Catalog Number: 2491R1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1048-2022·2022-05-18
Bronchofibervideoscope Sterilization and Disinfection Procedure Update Recall
Olympus is recalling 292 units of the BF-MP160F EVIS EXERA Bronchofibervideoscope due to updated instructions required for proper sterilization and reprocessing procedures. Updated guidance for chemical reprocessing, ETO gas sterilization, and disinfection rinsing steps is necessary.
Product
BF-MP160F: EVIS EXERA Bronchofibervideoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1070-2022·2022-05-18
Flexible video uretero-renoscopes recalled for inadequate sterilization
Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope (FLEX-XC) models because they may fail to achieve adequate disinfection, creating potential microbial contamination risk.
Product
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK F
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1068-2022·2022-05-18
Karl Storz Video Ureteroscopes May Not Be Properly Sterilized
Karl Storz ureteroscopes and flexible video ureteroscopes may fail to achieve adequate sterilization during the disinfection process, potentially leaving microorganisms on the devices that could cause patient infections.
Product
11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscop
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0721-2022·2022-03-09
Surgical knee navigation implant recalled over sterilization failures
Orthosoft's NavitrackER knee navigation system may lack proper sterilization. The product was distributed without passing required sterilization tests, risking infection.
Product
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0635-2022·2022-02-16
Acufex Access Advanced Positioning Kit Recalled for Missing Sterilization
Smith & Nephew is recalling the Acufex Access Advanced Positioning Kit because the products were shipped to a distribution center instead of the sterilizer and were not sterilized before distribution.
Product
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0145-2022·2021-10-27
Herniatome lumbar surgical instrument recalled for sterilization failure
ADRIA SRL recalls Herniatome surgical instruments (Model 5091745) distributed to New Jersey and New York due to sterilization process parameter failures.
Product
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
Category
Medical Device
Distribution
2 states