Hazard

Sterilization Failure recalls

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

What the numbers show

Total: 574
Critical: 3
Severe: 34
Most recent: 2026-07-22

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

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.

201–225 of 574

HighFDA (Devices)·Z-1869-2021·2021-06-23
HME for Tracheostomized Patients Recalled Due to Sterilization Process Deviations
Covidien LP is recalling HME (Heat and Moisture Exchanger) units for tracheostomized patients due to potential deviations from validated ethylene oxide sterilization parameters. The recall affects 10,890 units distributed worldwide and in specific U.S. states.
Product
HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1867-2021·2021-06-23
Mechanical respiratory filter recalls due to sterilization process deviation
Covidien, LP is recalling a mechanical respiratory filter (Item 351/5979) due to potential deviations in ethylene oxide sterilization. The product was distributed worldwide and in multiple U.S. states.
Product
Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1866-2021·2021-06-23
Electrostatic Filter Angled recalled for sterilization validation deviations
Covidien LP is recalling Electrostatic Filter Angled devices (Item 350S19006) due to potential deviations in ethylene oxide sterilization parameters. These respiratory airway devices for anesthetized patients may not meet required sterility standards.
Product
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1868-2021·2021-06-23
Covidien Respiratory Filters Recalled for Sterilization Process Deviations
Covidien is recalling Adult-Pediatric Electrostatic Filter HMEs due to potential deviations in ethylene oxide sterilization parameters. Approximately 192,000 units were distributed worldwide.
Product
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1743-2021·2021-06-09
10G Direct Single Bone Access Kits recalled for sterilization failure
Zavation's 10G Direct Single Bone Access Kits are being recalled because products distributed as sterile may not have been adequately sterilized, posing infection risk in orthopedic procedures.
Product
10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1745-2021·2021-06-09
10G Coaxial Cannulas Recalled Due to Inadequate Sterilization in Spinal Procedures
Zavation's 10G Coaxial Cannulas for spinal procedures may not have been adequately sterilized. The nationwide recall addresses potential infection risk from non-sterile surgical instruments.
Product
10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1724-2021·2021-06-09
Zavation Surgical Trocars Recalled Due to Sterilization Concerns
Zavation recalled 98 surgical trocars that may not be adequately sterilized. Products were distributed as sterile but may pose infection risks from inadequate sterilization.
Product
ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1708-2021·2021-06-09
ZVplasty Bone Access Kit Recalled for Inadequate Sterilization
Zavation has recalled the ZVplasty Direct Unipedicular Bone Access Kit with Drill due to potential sterilization failure. The surgical device is used in orthopedic and spinal procedures, with 11 units distributed nationwide.
Product
ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1767-2021·2021-06-09
ZVPlasty Orthopedic Spinal Device Recalled for Inadequate Sterilization
Zavation is recalling ZVPlasty spinal orthopedic devices that may not have been properly sterilized, creating a risk of infection. The recall affects 49 units distributed nationwide.
Product
ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1709-2021·2021-06-09
ZVplasty Unipedicular Cement Delivery Cannula Kit May Not Be Adequately Sterilized
Zavation recalls ZVplasty Unipedicular Cement Delivery Cannula Kit (72 units nationwide) due to sterilization failure. Products distributed as sterile may not have been adequately sterilized.
Product
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1768-2021·2021-06-09
Zavation OsteoFlex Cement Surgical System Recalled Due to Sterilization Concerns
Zavation is recalling OsteoFlex Cement and Mixing System used in spinal and orthopedic surgery due to potential sterilization failures. The 846 units distributed nationwide may not be adequately sterilized, creating a contamination risk.
Product
OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1728-2021·2021-06-09
Zavation recalls ZVplasty Diamond Tip Trocar due to sterilization failure
Zavation is recalling 113 units of ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) due to inadequate sterilization. The devices were distributed nationwide and may not be safe for use in orthopedic and spinal procedures.
Product
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1739-2021·2021-06-09
11G Direct Double Bone Access Kit May Not Be Adequately Sterilized
Zavation's 11G Direct Double Bone Access Kit for spinal and orthopedic procedures may not have been adequately sterilized during manufacturing. Distributed nationwide, the non-sterile devices may pose infection risks to patients.
Product
11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1738-2021·2021-06-09
Zavation 10G Direct Double Bone Access Kit May Not Be Properly Sterilized
Zavation recalled its 10G Direct Double Bone Access Kit used in orthopedic surgery because products distributed as sterile may not have been adequately sterilized, potentially exposing patients to infection.
Product
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2021·2021-06-09
ZVplasty Drill units may not have been adequately sterilized
Zavation recalled ZVplasty Drill units (REF VCF-1006, batch 19113036) distributed nationwide. The 38 affected units may not have been adequately sterilized, creating a risk of infection.
Product
ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1791-2021·2021-06-09
Terumo Sarns TCM II cardiac temperature controller cleaning protocol failure
The Sarns TCM II temperature control system used in cardiac surgery has been recalled due to inability to validate its cleaning protocol. Users are instructed to discontinue use and dispose of all affected devices.
Product
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorpor
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1713-2021·2021-06-09
Zavation surgical bone access kit recalled due to inadequate sterilization
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits because products distributed as sterile may not have been adequately sterilized. Patients who received these devices should contact their healthcare provider.
Product
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1782-2021·2021-06-09
Tranberg Laser Applicator Devices Recalled Due to Inadequate Sterilization
Clinical Laserthermia Systems recalls 90 units of Tranberg Laser Applicator devices distributed worldwide because single-use sterile devices may not have been adequately sterilized.
Product
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1747-2021·2021-06-09
Zavation 10G Cement Delivery Cannula Recalled for Inadequate Sterilization
Zavation is recalling its 10G Cement Delivery Cannula used in orthopedic and spinal procedures nationwide due to products distributed as sterile not being adequately sterilized.
Product
10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1789-2021·2021-06-09
Terumo HX2 and TCM Temperature Management Systems Recalled for Cleaning Protocol Issues
Terumo recalled the HX2 and TCM temperature management systems used in cardiac surgery due to inability to validate an updated cleaning protocol. Users should discontinue use and properly dispose of affected devices.
Product
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1731-2021·2021-06-09
10 Gauge Drill for Orthopedic Surgery Recalled for Sterilization Failure
Zavation recalled 58 units of 10 Gauge Drill (Lot 20102486) used in orthopedic/spinal procedures due to potential inadequate sterilization. Patients should contact their surgeon if they received treatment with an affected device.
Product
10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2021·2021-06-09
Orthopedic Bone Access Tools May Lack Proper Sterilization
Zavation is recalling InterV 10G Bone Access Tools (Lot 11613ZV) distributed nationwide because they may not have been adequately sterilized. No illnesses have been reported.
Product
InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1750-2021·2021-06-09
Zavation CEMIX Orthopedic Cement Mixing System Sterilization Recall
Zavation recalled 197 CEMIX cement mixing system units due to inadequate sterilization for orthopedic and spinal surgical use.
Product
CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1763-2021·2021-06-09
ZVplasty 10G FLEX Kyphoplasty Spinal Device Recall Due to Sterilization Failure
Zavation is recalling 19 units of ZVplasty 10G FLEX KYPHOPLASTY spinal devices because distributed units may not have been adequately sterilized, posing infection risk to patients.
Product
ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1742-2021·2021-06-09
Orthopedic bone access kits recalled for inadequate sterilization
Zavation recalled its 10G Direct Double Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. Affected devices are used in orthopedic and spinal procedures.
Product
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide