The Recall Desk

Hazard

Sterility Risk recalls

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

What the numbers show

Total
290
Critical
0
Severe
51
Most recent
2026-09-09

Of the 290 sterility risk recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 51 (18%) 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 sterility 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.

126–150 of 290

  • ModerateFDA (Devices)·Z-2415-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling specific dental implants because their pouches may not have been sealed during packing.

    Product
    Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2465-2016·2016-08-24

    Biomet 3i Recalls Gingihue Post Dental Implants Due to Sealing Defects

    Biomet 3i is recalling Gingihue Post Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Gingihue Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2420-2016·2016-08-24

    Biomet 3i Recalls Gold-Tite Hexed Retaining Screws Due to Sealing Defects

    Biomet 3i is recalling Gold-Tite Hexed Retaining Screws because pouches may not have been sealed during packing. The recall covers 1,648,273 units distributed worldwide.

    Product
    Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2409-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Dental Implants Due to Sealing Defects

    Biomet 3i is recalling specific Gingihue dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2454-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Conical EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Pick-Up Coping (Non-Hexed) Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2016·2016-08-24

    Biomet 3i Recalls Dental Implant Abutments Due to Sealing Defects

    Biomet 3i is recalling IOL Abutment and Screw dental implants because pouches may not have been sealed during packing.

    Product
    IOL Abutment and Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2490-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Pick-up Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Pick-up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2522-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Dental Implants Due to Sealing Issues

    Biomet 3i, LLC is recalling certain Gingihue 15 degree Pre-Angled Post Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue 15 degree Pre- Angled Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1454-2016·2016-08-10

    Isomeric Pharmacy Recalls Betamethasone Injectable Suspension Due to Particle Issues

    Isomeric Pharmacy Solution is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension due to potential drug clumps and larger particle sizes.

    Product
    Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1630-2016·2016-05-18

    Baxter Recalls GEM FlowCOUPLER Due to Packaging Lid Puncture Risk

    Baxter Healthcare is recalling 288 units of GEM FlowCOUPLER devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1162-2016·2016-03-23

    Zimmer Manufacturing Recalls Unipolar Endo Femoral Heads Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific unipolar endo femoral heads used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1099-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling sterile 1.5 x 6 Cortical Screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1155-2016·2016-03-23

    Zimmer Manufacturing Recalls Pressfit Femoral Stems Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling sterile pressfit femoral stems used in hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2016·2016-03-23

    Zimmer NexGen All-Poly Patella Components Recalled for Calibration Issues

    Zimmer Manufacturing B.V. is recalling NexGen All-Poly Patella and related knee arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0884-2016·2016-03-02

    Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0869-2016·2016-03-02

    Stryker Gamma K-Wire Recall Due to Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling Gamma K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0883-2016·2016-03-02

    Stryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1009-2015·2015-05-20

    Health Innovations Pharmacy Recalls Serum 50% BSS 50% Opth Drops

    Health Innovations Pharmacy is recalling Serum 50% BSS 50% Opth Drops due to lack of assurance of sterility and stability data. The recall covers all lots distributed in North Carolina.

    Product
    Serum 50% BSS 50% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1018-2015·2015-05-20

    Health Innovations Pharmacy Recalls Voriconazole Eye Drops for Sterility Concerns

    Health Innovations Pharmacy is recalling Voriconazole 1% Opth Drops due to quality control issues affecting sterility and stability data.

    Product
    Voriconazole 1% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1055-2015·2015-05-20

    Health Innovations Pharmacy Recalls Thymol 2% Solution Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Thymol 2% Solution because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    Thymol 2% Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1013-2015·2015-05-20

    Estradiol Vaginal Cream Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Estradiol 0.01% Vaginal Cream due to inspection findings regarding sterility and stability data.

    Product
    Estradiol 0.01% Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state