The Recall Desk

Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,429
Critical
25
Severe
988
Most recent
2026-09-03

Of the 3,429 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 988 (29%) 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 infection risk 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.

3051–3075 of 3429

  • HighFDA (Devices)·Z-1430-2014·2014-04-16

    Aspen Surgical Products Recalls Sterile Wound Drainage Kits

    Aspen Surgical Products is recalling sterile wound drainage kits due to a potential compromise of the sterile barrier.

    Product
    7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1423-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1421-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Devices Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage devices due to a potential compromise of the sterile barrier.

    Product
    Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1432-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.

    Product
    15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1319-2014·2014-04-09

    Merit Medical Pressure Monitoring Tubing Recalled for Sterilization Failure

    Merit Medical Systems is recalling 80 units of Pressure Monitoring Tubing PM6006 because the products were labeled as sterile but were not sterilized.

    Product
    Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2014·2014-03-19

    Biomet 3i Recalls Navigator Surgical Kits Due to Sterility Assurance Failure

    Biomet 3i, LLC is recalling 21 units of the Navigator Surgical Kit because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    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-1169-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 541 Contra-Angle Torque Driver Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    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
  • HighFDA (Devices)·Z-1171-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 181 dental torque driver kits because they failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2014·2014-03-19

    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 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, 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
  • HighFDA (Devices)·Z-1168-2014·2014-03-19

    Biomet 3i Recalls Tapered Navigator Surgical Kits Due to Sterility Failure

    Biomet 3i is recalling 170 Tapered Navigator Certain Surgical Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2014·2014-03-19

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

    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 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, 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
  • SevereFDA (Drugs)·D-1124-2014·2014-03-12

    Methylcobalamin Recalled Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all non-expired lots of Methylcobalamin due to quality control issues affecting sterility assurance.

    Product
    Methylcobalamin
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1125-2014·2014-03-12

    Novarel Injection Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all non-expired lots of Novarel (IM) due to quality control issues affecting sterility assurance.

    Product
    Novarel (IM)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1109-2014·2014-03-12

    FDA Recalls Estradiol and Testosterone Compounds for Sterility Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Estradiol Cypionate and Testosterone Cypionate due to sterility assurance concerns identified during an FDA inspection.

    Product
    Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg
    Category
    Drug
    Distribution
    1 state