The Recall Desk

Hazard

Sterility Risk recalls

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

What the numbers show

Total
288
Critical
0
Severe
50
Most recent
2026-07-29

Of the 288 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 50 (17%) 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.

101–125 of 288

  • HighFDA (Devices)·Z-2536-2021·2021-09-29

    C.R. Bard Foley Catheter Tray recalled for potential packaging defects

    C.R. Bard Inc is recalling approximately 29,890 units of Foley catheter trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries have been reported.

    Product
    Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0803-2021·2021-09-22

    MIC+Methyl B12 Injection Recalled for Lack of Processing Controls

    Promise Pharmacy is recalling MIC+Methyl B12 injection (57 vials, Lot# 06152021@2) distributed across five states due to lack of processing controls that may affect product quality and safety.

    Product
    MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS
    Category
    Drug
    Distribution
    5 states
  • HighFDA (Devices)·Z-2101-2021·2021-07-28

    Stryker Cortoss Bone Augmentation Material Recalled for Temperature Storage Violation

    Stryker Spine recalled Cortoss Bone Augmentation Material due to a 12-hour temperature excursion at the distribution center that could have compromised product sterility and efficacy.

    Product
    Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2088-2021·2021-07-28

    Fresenius APD Luer-Lock Adapter Recalled Due to Freezing Temperature Exposure

    Fresenius Medical Care is recalling 5 cases of the APD Luer-Lock Adapter (Lot 20LR08111) distributed in Texas after exposure to freezing temperatures during truck transport. Freezing may have compromised device sterility and functionality.

    Product
    The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, N
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2749-2020·2020-08-12

    Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Compromise

    Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.

    Product
    Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2020·2020-06-10

    FDA Recalls Sterile Surgical Packs from Unregistered Facility

    American Contract Systems is recalling sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs from Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2167-2020·2020-06-10

    FDA Recalls Sterile Surgical Packs from Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1643-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Drugs)·D-1109-2019·2019-04-17

    FDA Recalls Compounded Papaverine Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling compounded papaverine-phentolamine-PGE1 injectable due to insanitary conditions observed during an FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2912-2018·2018-09-05

    Stryker AXS PP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1045-2018·2018-08-15

    PharMEDium Recalls Rocuronium Bromide Syringes Due to CGMP Deviations

    PharMEDium Services, LLC is recalling 575 syringes of 10 mg/mL Rocuronium Bromide because the product was released while a hood certification discrepancy was under investigation.

    Product
    10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2559-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Intramedullary Nail Implants Due to Packaging Failures

    Zimmer Biomet is recalling sterile intramedullary nail implants and accessories because packaging design verification tests failed.

    Product
    Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0849-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i, LLC is recalling 160 units of Low Profile Abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0844-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling a limited number of dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0829-2017·2016-12-28

    Biomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect

    Biomet 3i is recalling 53 units of Low Profile 17° Abutments because some pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • 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-2509-2016·2016-08-24

    Biomet 3i Recalls EP Healing Abutments Due to Unsealed Pouches

    Biomet 3i is recalling specific EP Healing Abutments because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 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-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-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