Hazard

Sterilization Validation recalls

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

What the numbers show

Total: 16
Critical: 0
Severe: 0
Most recent: 2023-09-06

Of the 16 sterilization validation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterilization validation 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.

1–16 of 16

HighFDA (Drugs)·D-1107-2023·2023-09-06
FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 304 bags of cardioplegia solution nationwide due to lack of validation data for sterilization cycles.
Product
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1018-2023·2023-08-09
FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (High K) IV bags due to lack of sterility assurance from insufficient validation of decontamination processes.
Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total volume = 542 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0212-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0781-2023·2023-01-11
Steris VERIFY Steam Test Pack biological indicators show inconsistent performance
Steris Corporation is recalling VERIFY Steam Test Pack biological indicators (lot #230613) due to inconsistent performance in promoting spore growth. When used to monitor sterilization, some indicators may not show growth even if the sterilization cycle was ineffective, creating false assurance of sterility.
Product
VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3036-2018·2018-09-19
SPS Sterilization Recalls Boston Scientific Wallstent Tracheobronchial Stents
SPS Sterilization is recalling two Boston Scientific Wallstent tracheobronchial stents because the expiration date on the labeling exceeds the validated shelf life of the sterilization process.
Product
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-3038-2018·2018-09-19
SPS Sterilization Recalls Resterilized Boston Scientific Wallstent Enteral Endoprosthesis
SPS Sterilization, Inc. is recalling two units of resterilized Boston Scientific Wallstent Enteral Endoprosthesis because the expiration date on the labeling exceeds the validated shelf life.
Product
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-2181-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, correspond
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2165-2015·2015-07-29
Fiber Stripper Recalled for Cleaning and Sterilization Validation Issues
American Medical Systems is recalling Fiber Strippers because validation data for cleaning and sterilization methods does not meet FDA guidance for reusable products.
Product
Fiber Stripper, 200¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2185-2015·2015-07-29
FDA Recalls Disposable Fiber Strippers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2170-2015·2015-07-29
FDA Recalls Fiber Cleaver Accessories Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Cleaver accessories because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2159-2015·2015-07-29
FDA Recalls Sureflex 365 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Sureflex 365 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2173-2015·2015-07-29
American Medical Systems Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, correspond
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2168-2015·2015-07-29
American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues
American Medical Systems is recalling Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2184-2015·2015-07-29
FDA Recalls American Medical Systems Fiber Strippers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2183-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, correspond
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2171-2015·2015-07-29
FDA Recalls Fiber Cleavers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Cleavers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
Product
1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotri
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1961-2012·2012-07-18
Stryker Arthroscope and Hardware Set Tray Recall for Sterilization Labeling
Stryker Endoscopy is recalling 6,388 Arthroscope and Hardware Set Trays because the Instructions for Use incorrectly listed sterilization methods that were not validated at worst-case conditions.
Product
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the ster
Category
Medical Device
Distribution
Distributed nationwide