The Recall Desk

Hazard

Particulate Contamination recalls

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

What the numbers show

Total
71
Critical
6
Severe
27
Most recent
2026-08-05

Of the 71 particulate contamination recalls we have scored against our rubric, 6 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 27 (38%) 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 particulate contamination 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.

26–50 of 71

  • SevereFDA (Drugs)·D-0556-2022·2022-02-16

    Polymyxin B for Injection Recalled Due to Particulate Matter Contamination

    AuroMedics Pharma LLC is recalling Polymyxin B for Injection USP (Lot CPB200013) nationwide due to the presence of particulate matter, including hair, found in vials.

    Product
    POLYMYXIN B — POLYMYXIN B (POLYMYXIN B)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0093-2022·2021-11-10

    Cubicin daptomycin injection recalled for glass particle contamination

    Merck Sharp & Dohme Corp. is recalling Cubicin (daptomycin for injection) 500 mg vials due to the presence of glass particles. The recall affects a single lot distributed nationwide.

    Product
    Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0661-2021·2021-07-14

    Topotecan Injection recalled for particulate contamination

    Teva Pharmaceuticals is recalling Topotecan Injection 4 mg/4mL single-dose vials due to the presence of particulate matter, including glass, silicone, and cotton fiber, found inside affected vials.

    Product
    Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2042-2020·2020-05-27

    Medline Silicone Foley Catheters Recalled Due to Loose Silicone Particulate

    Medline Industries is recalling 330 units of 100% Silicone Foley Catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1416-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled Due to Unknown Contamination Levels

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1413-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1412-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1011-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1025-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 fabric-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1035-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1022-2020·2020-02-12

    Cardinal Health Recalls Royalsilk Gowns Due to Unknown Contamination

    Cardinal Health is recalling approximately 7.7 million Royalsilk gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    ROYALSILK LARGE, Gown. Item Code 9518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1014-2020·2020-02-12

    Cardinal Health Recalls RoyalSilk Gowns Due to Unknown Contamination

    Cardinal Health is recalling RoyalSilk gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1024-2020·2020-02-12

    Cardinal Health Recalls RoyalSilk Gowns Due to Unknown Contamination

    Cardinal Health is recalling RoyalSilk gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1028-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 Non-Reinf Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1023-2020·2020-02-12

    Cardinal Health Recalls ROYALSILK Gowns Due to Unknown Contamination

    Cardinal Health is recalling ROYALSILK gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    ROYALSILK 2XLARGE, Gown. Item Code 9578
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1009-2020·2020-02-12

    Cardinal Health recalls surgical gowns due to unknown contamination levels

    Cardinal Health is recalling AAMI 3 Royalsilk surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1013-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Royalsilk Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Nonreinforced Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 nonreinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling specific lots of AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 fabric-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 non-radiation-protective surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2020·2020-02-12

    Cardinal Health Recalls RoyalSilk Gowns Due to Unknown Contamination

    Cardinal Health is recalling RoyalSilk XLARGE gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    ROYALSILK XLARGE, Gown. Item Code 9548
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Burr Risk

    ICU Medical is recalling certain lots of ChemoClave Vented Vial Spikes because plastic burrs from the protective cap may contaminate the device.

    Product
    icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contamina
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2019·2018-10-17

    Bayer Recalls Codan Filters Due to Potential Particulate Contamination

    Bayer is recalling Codan Filters used in IV administration sets because the dust cap may generate particulate that enters the fluid path.

    Product
    Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0315-2018·2018-01-10

    Centurion Recalls Convenience Kits Contaminated with Particulate Matter

    Centurion Medical Products is recalling specific lots of convenience kits containing BD SafetyGlide needles due to particulate contamination.

    Product
    SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
    Category
    Medical Device
    Distribution
    0 states