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.

51–60 of 60

  • HighFDA (Devices)·Z-2244-2019·2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 1.1x150mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - 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-2252-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x90 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x90, Item Number 19666 - 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-2259-2019·2019-08-21

    BioPro K-Wire HBS Sterile Lots Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile Lots due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire HBS Sterile Lot, Item Number 19688 - 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-1309-2018·2018-04-11

    C.R. Bard Recalls Personal Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling Personal Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.

    Product
    Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G, 53612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2018·2018-04-11

    C.R. Bard Recalls HydroSil Gripper Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling specific lots of HydroSil Gripper Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.

    Product
    HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0940-2018·2018-03-21

    Howmedica Recalls Accolade and Restoration Hip Products Due to Barrier Defects

    Howmedica Osteonics Corp. is recalling 255 Accolade and Restoration hip products because the inner and outer sterile barriers were not fully sealed.

    Product
    Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0317-2018·2018-01-17

    Repro-Med Systems Recalls Freedom60 Precision Flow Rate Tubing Sets

    Repro-Med Systems is recalling Freedom60 Precision Flow Rate Tubing Sets and related needle sets because gaps were found in the sterile barrier packaging during inspection.

    Product
    Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2014·2014-03-19

    DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defects

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices due to potential holes in the sterile barrier pouches.

    Product
    REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2014·2014-03-19

    DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defect

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.

    Product
    REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1206-2014·2014-03-19

    DePuy S-ROM Rotating Hinge Femoral Components Recalled for Sterile Barrier Defects

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femoral components due to potential holes in the sterile barrier pouches.

    Product
    REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is nee
    Category
    Medical Device
    Distribution
    Distributed nationwide