The Recall Desk

Hazard

Bioburden recalls

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

What the numbers show

Total
56
Critical
0
Severe
16
Most recent
2025-02-05

Of the 56 bioburden recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 16 (29%) 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 bioburden 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 56

  • HighFDA (Devices)·Z-1036-2020·2020-02-12

    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 SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 ROYALSILK SURGGOWN BNS XL units worldwide due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown 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 SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
    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-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-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-1034-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

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

    Product
    AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511
    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-1010-2020·2020-02-12

    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 XL, Gown. Item Code 90380NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

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

    Product
    AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1032-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

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

    Product
    GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    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 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling 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 3XL XLONG, Gown. Item Code 95995
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    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 2XL, Item Code 9571
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1077-2019·2019-04-10

    Morphine Sulfate API Recalled for Microbial Contamination Out of Specification

    Johnson Matthey Inc. is recalling Morphine Sulfate USP Milled API due to bioburden out of specification results.

    Product
    Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1249-2018·2018-04-04

    Stryker Spinal Orthopedic PCD Kit Recalled for Sterility Assurance Issues

    Stryker is recalling 12 units of a spinal orthopedic PCD kit because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.

    Product
    PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1244-2018·2018-04-04

    Stryker Recalls 180-Gram Cement Cartridges Due to Sterility Assurance Issues

    Stryker is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles because bioburden levels were found to be higher than internal acceptable rates.

    Product
    180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1248-2018·2018-04-04

    Stryker Recalls Advanced Cement Mixing Kits Due to Sterility Concerns

    Stryker is recalling 1,542 Advanced Cement Mixing Kits because bioburden levels exceeded acceptable rates, posing a sterility risk.

    Product
    Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1246-2018·2018-04-04

    Stryker InterPulse Handpieces Recalled for Sterility Assurance Issues

    Stryker is recalling InterPulse Handpieces because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.

    Product
    1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip,
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1255-2018·2018-04-04

    Stryker Recalls Intramedullary Brushes Due to Sterility Assurance Failure

    Stryker is recalling 320 Intramedullary Brushes because bioburden levels exceeded acceptable rates, compromising sterility assurance.

    Product
    Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1251-2018·2018-04-04

    Stryker Recalls 30 Revolution 90 Degree Tibial Nozzles for Sterility Issues

    Stryker is recalling 30 units of the Revolution 90 Degree Tibial Nozzle because bioburden levels exceeded acceptable rates, posing a sterility risk.

    Product
    Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1245-2018·2018-04-04

    Stryker Recalls Femoral Canal Pressurizers Due to Sterility Assurance Issues

    Stryker is recalling specific lots of Femoral Canal Pressurizers because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0835-2018·2018-03-14

    Stryker Recalls StrykeFlow 2 System Due to Bioburden Testing Results

    Stryker is recalling 60,753 units of the StrykeFlow 2 System because routine bioburden testing found levels higher than internal acceptable rates.

    Product
    StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0837-2018·2018-03-14

    Stryker Recalls ACL Interface Screws Due to Bioburden Levels

    Stryker is recalling specific lots of ACL Interface Screws because routine testing found bioburden levels higher than internal acceptable rates.

    Product
    STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0838-2018·2018-03-14

    Stryker Recalls ACL Disposable Packs Due to Bioburden Levels

    Stryker is recalling ACL Disposable Pack Bone-Tendon-Bone units because routine testing found bioburden levels higher than internal acceptable rates.

    Product
    ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
    Category
    Medical Device
    Distribution
    0 states