The Recall Desk

Hazard

Inadequate Sterilization recalls

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

What the numbers show

Total
92
Critical
0
Severe
2
Most recent
2026-08-19

Of the 92 inadequate sterilization recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (2%) 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 inadequate sterilization 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.

1–25 of 92

  • HighFDA (Devices)·Z-2941-2026·2026-08-19

    BD Medical Extension Sets Recalled for Potential Sterilization Defects

    BD Switzerland is recalling 93,700 intravascular extension sets because they may not have received adequate sterilization processing.

    Product
    60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2718-2026·2026-07-22

    Olympus Toomey Evacuator 30cc medical device sterilization parameters recalled

    Olympus Corporation recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.

    Product
    Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2025·2025-02-05

    Karl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions

    Karl Storz ureteroscopes are being recalled because their instructions contain reprocessing procedures that have not been reviewed or approved by the FDA. The recall affects 3,069 units distributed nationwide.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2025·2025-02-05

    Medline procedure kits recalled for surgical masks failing sterilization tests

    Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.

    Product
    Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3220-2024·2024-10-02

    Karl Storz Hopkins Telescope 6 endoscope recalled for unapproved reprocessing instructions

    Karl Storz is recalling the Hopkins Telescope 6 endoscope because its Instructions for Use contain reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 1,982 units distributed nationwide.

    Product
    Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2518-2024·2024-08-14

    Gyn Laparoscopy Kits Recalled Due to Inadequate Sterilization Process

    American Contract Systems is recalling 29 gynecological laparoscopy surgical kits due to insufficient aeration during sterilization, which may compromise sterility and increase infection risk for patients.

    Product
    American Contract Systems Gyn Laparoscopy convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2024·2024-05-22

    Karl Storz Laser Surgical Instruments Recalled Due to Sterilization Concerns

    Karl Storz laser surgical instruments lack validated sterilization procedures, creating infection risk after reprocessing. The FDA has recalled 85 units distributed nationwide and in Argentina.

    Product
    LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0971-2023·2023-08-09

    FDA Recalls Vancomycin IV Bags Over Sterility Assurance Deficiency

    Central Admixture Pharmacy Services is recalling 1,927 bags of vancomycin IV bags (750 mg/250 mL) distributed nationwide due to lack of sterility assurance and insufficient decontamination validation.

    Product
    vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6071-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2023·2023-06-28

    Medline TheraHoney Gel Wound Dressing Recalled for Sterilization Failure

    Medline is recalling 851,328 units of TheraHoney Gel wound dressing due to inadequate sterilization. The manufacturer failed to augment the sterilization dose after an audit failure, violating ISO 11137 standards.

    Product
    MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2023·2023-05-24

    FDA Recalls DuraLife Silicone Breathing Tube Extension Over Sterilization Guidance

    Smiths Medical ASD recalled 14,941 DuraLife silicone extension tubes worldwide due to incomplete sterilization instructions that could compromise patient safety.

    Product
    DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1163-2023·2023-03-01

    Medline Sterile Hand Pack recalled for inadequate sterilization

    Medline Sterile Hand Pack surgical prep kits are recalled because components were improperly placed in the nonsterile portion of the tray and did not receive proper sterilization. Affects 1,689 trays distributed in AR, CO, and GA.

    Product
    (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and (2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0205-2023·2022-11-23

    CareFusion Genesis STERRAD containers fail sterilization testing

    Healthcare sterilization containers failed aerosol challenge testing, indicating potential inadequate sterilization of surgical instruments. 493 units affected across US and international markets.

    Product
    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0203-2023·2022-11-23

    CareFusion Genesis Mini Sterilization Containers fail aerosol testing

    CareFusion Genesis Mini Containers used for surgical instrument sterilization have not consistently met aerosol challenge testing requirements, which may affect their ability to protect instruments during sterilization.

    Product
    CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0215-2023·2022-11-23

    GENESIS Full-Length Sterilization Containers recalled for failed aerosol testing

    CareFusion 2200 Inc recalls GENESIS sterilization containers (model CD3-7ST, all lots) that have not consistently met aerosol challenge testing requirements required for proper sterilization efficacy.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2162-2021·2021-08-04

    Coaxial Interventional Needles Recalled for Potential Sterilization Defects

    INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling Coaxial Interventional Needles distributed in California due to potential sterilization defects. Needles labeled as sterile may not have been adequately sterilized, creating infection risks.

    Product
    Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2021·2021-06-09

    ZVplasty Direct Access Trocar Recalled for Inadequate Sterilization

    Zavation is recalling ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) because some units may not be adequately sterilized. These surgical instruments are used 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-1753-2021·2021-06-09

    Orthopedic Spinal Surgery Kit Recalled for Inadequate Sterilization

    Zavation is recalling InterV CurvePlus surgical kits because products distributed as sterile may not have been adequately sterilized. 36 units were distributed nationwide.

    Product
    InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2021·2021-06-09

    Zavation InterV 10G kyphoplasty kits recalled due to inadequate sterilization

    Zavation is recalling InterV 10G Kyphoplasty Kits because products distributed as sterile may not have been adequately sterilized. The recall affects 503 units distributed nationwide.

    Product
    InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2021·2021-06-09

    Spinal surgical cement delivery cannulas recalled for inadequate sterilization

    Zavation is recalling 130 units of 10-gauge cement delivery cannulas used in spinal procedures due to inadequate sterilization. These devices may not be sterile, creating infection risk for surgical patients.

    Product
    10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1781-2021·2021-06-09

    Tranberg MR Stylet Recalled Due to Inadequate Sterilization

    CLINICAL LASERTHERMIA SYSTEMS AB is recalling Tranberg MR Stylet devices (lot IDs 116540030718 and 116540201117) because single-use units labeled as sterile may not have been adequately sterilized, creating infection risk.

    Product
    Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, 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-1729-2021·2021-06-09

    Orthopedic Drill Kit Recalled for Potential Sterilization Failure

    Zavation is recalling the ZVplasty Direct Bipedicular Bone Access Kit due to products potentially lacking adequate sterilization. The 15 units affected (Lot 20071774, 19123262) were distributed nationwide.

    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-1701-2021·2021-06-09

    Cement Delivery Cannula May Not Be Adequately Sterilized

    Zavation is recalling 10 gauge cement delivery cannulas (INTVM-CDC) used in orthopedic procedures because distributed products may not have been adequately sterilized. The recall affects 130 units distributed nationwide.

    Product
    10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2021·2021-06-09

    Zavation 10G Direct Single Bone Access Kit Recall Due to Inadequate Sterilization

    Zavation is recalling its 10G Direct Single Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. The kit is used in orthopedic and spinal procedures and was distributed nationwide.

    Product
    10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1759-2021·2021-06-09

    ZVplasty Orthopedic Spinal System Units Recalled Due to Inadequate Sterilization

    Zavation is recalling 516 units of ZVplasty System (15mm) spinal surgical devices because products distributed as sterile may not have been adequately sterilized. Patients who received this device may face infection risk.

    Product
    ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide