The Recall Desk

Hazard

Sterilization Defect recalls

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

What the numbers show

Total
58
Critical
0
Severe
2
Most recent
2026-05-13

Of the 58 sterilization defect 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 (3%) 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 defect 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 58

  • SevereFDA (Devices)·Z-2097-2026·2026-05-13

    Medline Convenience Kits recalled for potential sterilization issues

    Medline Industries is recalling multiple convenience kit models due to calibration issues with equipment used to sterilize and package the devices, which could affect sterility assurance levels.

    Product
    See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2118-2026·2026-05-13

    Medline Convenience Kits recalled for potential sterility assurance defects

    Medline Industries is recalling six models of medical device convenience kits due to calibration issues with sterilization and packaging equipment that may have reduced sterility assurance levels. The recall affects 553 units distributed nationwide.

    Product
    Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTAN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2026·2026-05-13

    Medline PPE Kit recalled for sterilization calibration issues

    Medline is recalling Convenience Kits (PPE Kit, Model DYK1011945P) due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. The product was distributed nationwide.

    Product
    Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2125-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization equipment calibration issues

    Medline Industries is recalling three models of medical trays due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects LVAD Driveline Trays and Central Line Dressing Change Trays distributed nationwide.

    Product
    Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2120-2026·2026-05-13

    Medline Burn Care Kits Recalled Due to Sterilization Calibration Issues

    Medline Industries is recalling three burn care convenience kits because calibration issues with sterilization and packaging equipment could compromise their sterility assurance level.

    Product
    Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1356-2025·2025-03-26

    AV Fistula Kit Recall Due to Unconfirmed Sterilization Assurance

    American Contract Systems Inc is recalling 90 AV Fistula kits because sterilization assurance requirements cannot be confirmed. Possible loss of functionality could delay or prolong patient treatment.

    Product
    AV FISTULA , Model No UTAV77T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3218-2024·2024-10-02

    Karl Storz Hopkins Telescope 6 endoscope with unapproved reprocessing instructions

    Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.

    Product
    Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0845-2024·2024-02-07

    Surgical sutures recalled due to substandard gamma sterilization doses

    Covidien is recalling multiple surgical suture products because certain lots were sterilized with gamma doses exceeding approved levels. The excess radiation may reduce suture strength over time, potentially causing wound failure and bleeding.

    Product
    Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2024·2023-11-01

    Pediatric Urology Equipment Recalled Due to Improper Sterilization

    American Contract Systems is recalling Pediatric Urology Wolson Packs due to components being exposed to unapproved sterilization processes. Components may have lost functionality or reduced efficacy, potentially compromising device performance.

    Product
    Pediatric Urology Wolson Pack, REF BPPU55A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1005-2023·2023-08-09

    Neonatal TPN IV Bags Recalled Over Sterility Assurance Failures

    Central Admixture Pharmacy Services is recalling 304 neonatal TPN IV starter bags nationwide due to lack of sterility assurance and insufficient validation of decontamination processes. No illnesses have been reported.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2023·2023-05-24

    Breathing circuit swivel elbow recalled for inadequate sterilization instructions

    Smiths Medical is recalling DuraLife Swivel Elbow breathing circuit devices due to inadequate sterilization instructions. The device instructions lack cleaning methods, autoclave cycle duration, and reuse specifications.

    Product
    DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2023·2023-04-12

    Endoscopic vessel harvesting system recalled for sterilization defect

    900 units of Maquet Cardiovascular's VASOVIEW HEMOPRO endoscopic vessel harvesting system are being recalled because some batches were not sterilized to their minimum specification, creating a potential infection risk for surgical patients.

    Product
    VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0106-2023·2022-10-26

    Chest Tube Insertion Tray Recalled Due to Over-Sterilization of Suture Component

    Medline recalls CENTURION SnagFree Chest Tube insertion trays because a silk suture component was sterilized twice instead of once, potentially compromising its integrity. The affected lot contains 18 kits distributed in California and Texas.

    Product
    CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2022·2022-05-18

    ACS IR Angio Pack Sterilization Process Defect Recall

    The ACS IR Angio Pack from American Contract Systems, Inc. was sterilized using ethylene oxide at higher than specification concentration. No illnesses or injuries have been reported.

    Product
    ACS IR - Angio Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2022·2022-05-18

    Spine Surgery Instrument Sets Recalled for Sterilization Defect

    American Contract Systems is recalling ACS Spine Pack and ACS Lumbar/Back Set Up Tray surgical instrument sets due to improper sterilization with excess ethylene oxide. The affected sets were distributed in Illinois, Missouri, Nebraska, and Texas.

    Product
    1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1040-2022·2022-05-18

    ACS Cath Lab Packs Sterilized with Excess Ethylene Oxide

    American Contract Systems recalls ACS Cath Lab Packs distributed in IL, MO, NE, and TX because they were sterilized with higher than specification ethylene oxide concentrations.

    Product
    ACS Cath Lab Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2021·2021-08-25

    I.V. Catheter Recall: Sterilization Defects in NEO DELTA Self Safe Devices

    Delta Med is recalling 10,000 units of NEO DELTA Self Safe I.V. Catheters due to sterilization defects. Affected devices were distributed in Florida and Minnesota.

    Product
    NEO DELTA Self Safe, I.V. Catheter REF 3738222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2021·2021-07-21

    Silicone thoracic/abdominal catheter recall due to potential sterilization defect

    RanD S.r.l. is recalling Ch24 round silicone catheters used in thoracic and abdominal cavity drainage due to a sterilization process quality issue. Some units in affected lots may not be sterile.

    Product
    Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1968-2021·2021-07-07

    SNS Disposable Urethral Catheter Electrode Recalled for Sterilization Process Deviations

    Spes Medica is recalling SNS Disposable Urethral Catheter Electrodes due to possible deviations in the ethylene oxide sterilization process. The recalled units may not be adequately sterilized, posing a potential infection risk to users.

    Product
    SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1719-2021·2021-06-09

    Zavation Direct Working Cannula Recalled for Sterilization Defect

    Zavation is recalling 58 units of 11G Direct Working Cannula Diamond Tip Mini devices (Lot 2002437) because they may not have been adequately sterilized before distribution.

    Product
    11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2021·2021-06-09

    Zavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization

    Zavation is recalling 10G Double Cement Delivery Kits used in orthopedic and spinal procedures due to potential inadequate sterilization, creating a risk of surgical site infection.

    Product
    10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2021·2020-10-21

    Biomet Recalls RingLoc Hip Cups Due to Double Sterilization

    Biomet is recalling 48 RingLoc Bi-Polar Hip System Acetabular Cups because they were gamma sterilized twice, which may compromise functionality and shelf life.

    Product
    (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, Ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0083-2021·2020-10-14

    Biomet ONPOINT SCOPE PROCEDURE KIT-EU Recalled for Sterilization Defect

    Biomet, Inc. is recalling ONPOINT SCOPE PROCEDURE KIT-EU units because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2020·2020-02-19

    LivaNova Recalls Six VNS Therapy SENTIVA Generators for Sterilization Error

    LivaNova USA Inc is recalling six VNS Therapy SENTIVA Generator Model 1000 units because they were sterilized one additional cycle, failing to meet quality specifications.

    Product
    VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)
    Category
    Medical Device
    Distribution
    5 states