The Recall Desk

Hazard

Sterile Barrier Defect recalls

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

What the numbers show

Total
60
Critical
0
Severe
0
Most recent
2026-08-19

Of the 60 sterile barrier 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 0 (0%) are Severe.

About this hazard tag

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

26–50 of 60

  • HighFDA (Devices)·Z-1655-2023·2023-06-07

    QUADROX-i Pediatric Oxygenators Recalled for Packaging Sterility Defects

    QUADROX-i Pediatric Oxygenators used in cardiopulmonary bypass surgery are recalled for packaging defects that may compromise sterility, potentially causing inflammation, infection, sepsis, or ischemia.

    Product
    QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1658-2023·2023-06-07

    QUADROX-iD Pediatric Oxygenator Recalled Due to Packaging Sterile Barrier Defect

    Maquet Medical Systems USA recalls 5,022 QUADROX-iD Pediatric Oxygenators distributed nationwide due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices.

    Product
    QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2023·2022-12-21

    DeRoyal Total Knee Procedure Pack Recalled for Defective Steri Drapes

    DeRoyal Industries is recalling 79 units of GEO-MED TOTAL KNEE PACK A & B due to defective 3M Steri Drapes included in the procedure packs. The affected units were distributed across 23 states.

    Product
    GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-1552-2022·2022-08-24

    FDA Recalls Stradis Medical Surgical Scissors Due to Compromised Sterile Barrier

    Stradis Medical is recalling NARMD MEDICAL DEPOT Iris Curved Scissors (Part Number ZZ-0697) because the sterile barrier may be compromised, potentially exposing patients to contamination during surgical procedures.

    Product
    NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2021·2021-09-29

    Foley Catheter Tray Recalled for Packaging Defects Affecting Sterile Barrier

    C.R. Bard Inc is recalling SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. The affected lot includes 1140 units distributed nationwide.

    Product
    Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2021·2021-09-29

    C.R. Bard SureStep Foley Catheter Tray Sterile Barrier Defect Recall

    C.R. Bard is recalling 5,950 SureStep Foley Tray kits nationwide due to potential packaging defects that may impact the sterile barrier.

    Product
    Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2539-2021·2021-09-29

    SureStep Foley Catheter Tray Recalled for Sterile Barrier Packaging Defect

    C.R. Bard Inc is recalling approximately 4830 SureStep Foley catheter trays due to potential packaging defects that could compromise the sterile barrier.

    Product
    Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2537-2021·2021-09-29

    C.R. Bard Foley Catheter Tray Recall Due to Packaging Defects

    C.R. Bard Inc is recalling the SureStep Foley Tray (Lot NGEVX108) due to potential packaging defects that may affect the sterile barrier. The product was distributed nationwide.

    Product
    Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2021·2021-09-29

    C.R. Bard SureStep Foley Tray Recalled for Packaging Defect Risk

    C.R. Bard is recalling SureStep Foley Tray units due to potential packaging defects that may compromise the sterile barrier. The recalled product was distributed nationwide in the United States.

    Product
    Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2021·2021-09-29

    Foley Catheter Tray Recalled Due to Potential Packaging Defects

    C.R. Bard is recalling 2,660 units of SureStep Foley Catheter Trays nationwide due to potential packaging defects that may impact the sterile barrier.

    Product
    Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2021·2021-09-29

    SureStep Foley Tray Recall: Packaging Defects May Compromise Sterile Barrier

    C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616) due to packaging defects that may compromise the sterile barrier. Affected units were distributed nationwide.

    Product
    Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2533-2021·2021-09-29

    Foley Catheter Tray Packaging Defect Poses Sterile Barrier Risk

    C.R. Bard Inc is recalling a Foley catheter tray due to potential packaging defects that may compromise the sterile barrier. Approximately 1,710 units were distributed nationwide.

    Product
    Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2534-2021·2021-09-29

    C.R. Bard Foley Catheter Kits Recalled for Potential Sterile Barrier Defects

    C.R. Bard is recalling 960 units of Foley Tray catheter kits (lot NGFR0101) due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2524-2021·2021-09-29

    C.R. Bard Foley Catheter Kit Recall: Packaging Sterility Defect

    C.R. Bard is recalling Foley catheter kits due to packaging defects that may compromise the sterile barrier. No illnesses have been reported.

    Product
    Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2021·2021-09-29

    C.R. Bard Foley Tray and Drainage Bag Recalled for Packaging Defects

    C.R. Bard is recalling 11,780 Foley Tray units nationwide due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2021·2021-09-29

    C.R. Bard Foley Tray Recalled for Potential Sterile Barrier Packaging Defects

    C.R. Bard Inc is recalling Foley Tray kits nationwide due to potential packaging defects that may compromise the sterile barrier. The product was distributed throughout the United States.

    Product
    Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2021·2021-04-14

    Sharp Medical Reactor and Sleeve Recalled for Sterile Barrier Defects

    Sharp Medical Products is recalling 129 units of Reactor and Sleeve REF 100-36-01 due to holes, punctures, or deep creases in the sterile barrier.

    Product
    SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2251-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x85 due to a manufacturing flaw in the sterile barrier system. The devices were distributed in the US and internationally.

    Product
    Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2248-2019·2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x36 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x100 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2253-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x115 due to a manufacturing flaw in the sterile barrier system. The devices are intended for orthopedic surgical procedures.

    Product
    Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2254-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x32 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x38 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2019·2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 2.5x170mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2250-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x34 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide