The Recall Desk

Hazard

Loss Of Sterility recalls

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

What the numbers show

Total
333
Critical
26
Severe
45
Most recent
2026-08-12

Of the 333 loss of sterility recalls we have scored against our rubric, 26 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (14%) 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 loss of sterility 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.

326–333 of 333

  • HighFDA (Devices)·Z-2503-2014·2014-09-10

    Customed Recalls Minor Packs Due to Potential Packaging Integrity Compromise

    Customed, Inc. is recalling 200 units of EO sterilized minor packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" (16) GAUZE SPONGES 2" X 2" 8PLY (1) TRAY HALF SHALLOW (12) COTION TIP APPLICATOR 6" WOOD (2) GLOVE SKY NITRILE PF BLUE MED (18) GAUZE SPONGES 4" X 4" 12PLY (1) SMALL DRAPE W/ADH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2516-2014·2014-09-10

    Customed Recalls Basic Pack FPSC Florham Pack Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Basic Pack FPSC Florham Pack surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) TOWELS ABSORBENT 15" X 20" (4)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2534-2014·2014-09-10

    Customed Recalls Lithotomy Pack III Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Lithotomy Pack III surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LARGE STANDARD SMS VELCRO NECK (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1) COV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2014·2014-09-10

    Customed Recalls Laparoscopic Colorectal Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling specific lots of laparoscopic colorectal surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAIN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2313-2014·2014-09-10

    Customed Recalls Angiography Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 30 lots of angiography packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF (2) MEDICINE CUP 2oz. LIF (3) UTILITY BOWL 32oz UF (1) EMESIS BASIN 10 IN 700cc (4) TOWEL CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1425-2014·2014-07-16

    Hospira Recalls Heparin Sodium Bags Due to Sterility Concerns

    Hospira is recalling 142,152 bags of Heparin Sodium in 5% Dextrose Injection due to a confirmed report of fluid leaking from the primary container, which compromises sterility.

    Product
    HEPARIN SODIUM AND DEXTROSE — HEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0877-2014·2014-02-05

    Synergetics Recalls 25ga Awh Chandelier Due to Faulty Sterile Seals

    Synergetics Inc. is recalling 36 units of 25ga Awh Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.

    Product
    25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-176-2013·2013-03-06

    Hospira Recalls 0.9% Sodium Chloride Irrigation Due to Sterility Concerns

    Hospira Inc. is recalling 56,854 units of 0.9% Sodium Chloride Irrigation, USP, 3000 mL, due to a potential leak from the administration port that compromises sterility.

    Product
    0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
    Category
    Drug
    Distribution
    Distributed nationwide