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.

276–288 of 288

  • HighFDA (Drugs)·D-0104-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Morphine Sulfate Syringes for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded morphine sulfate syringes due to quality control observations that present a risk to sterility assurance.

    Product
    Morphine sulfate (PF) 3 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0096-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Lidocaine Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Lidocaine (PF) 1% injectable vials due to quality control issues that may compromise sterility assurance.

    Product
    Lidocaine (PF) 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0155-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix ST1 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST1 injectable vials because FDA inspection findings raised concerns about sterility assurance.

    Product
    Tri-mix ST1, 30 mg/1.5 mg/50 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0093-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Hydroxocobalamin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Hydroxocobalamin 10 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Hydroxocobalamin 10 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0083-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Histamine Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Histamine 0.55 mg/mL injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.

    Product
    Histamine 0.55 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0110-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Veterinary Injection Suspension Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling veterinary injection suspensions due to quality control observations that present a risk to sterility assurance.

    Product
    Peng/proc/strep/chlor/hyos (penicillin G, procaine, streptomycin sulfate, chlorpheniramine maleate, hyoscyamine sulfate) (vet) injection suspension packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0166-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix T25 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix T25 injectable vials because quality control observations during an FDA inspection presented a risk to sterility assurance.

    Product
    Tri-mix T25, 4.413 mg/0.145 mg/1.475 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2552-2014·2014-09-03

    Zimmer Recalls Knee Stem Extensions Due to Packaging Design Failures

    Zimmer, Inc. is recalling specific knee stem extensions and impactor sleeves because packaging design verification tests failed, potentially compromising device sterility.

    Product
    Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMD
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1039-2014·2014-02-26

    Zimmer Recalls Compression Screws Due to Packaging Validation Review

    Zimmer is recalling 7,044,680 compression screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1002-2014·2014-02-26

    Zimmer Recalls Bone Screws Due to Packaging Validation Deficiencies

    Zimmer is recalling specific bone screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1005-2014·2014-02-26

    Zimmer Recalls Versa-FX II Knee Implants Due to Packaging Validation Issues

    Zimmer is recalling Versa-FX II knee implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2311-2013·2013-10-09

    Atrium Medical Recalls Advanta SST Grafts Due to Label Adhesion

    Atrium Medical Corporation is recalling Advanta SST Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2058-2013·2013-09-04

    Synthes Trauma Nail System Recalled for Potential Outer Pouch Compromise

    Synthes USA HQ, Inc. is recalling Trauma Nail Systems because the outer packaging pouch may be compromised, potentially affecting the sterile internal pouch.

    Product
    Synthes Trauma Nail System. The devices are indication for bone fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide