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.

51–56 of 56

  • ModerateFDA (Devices)·Z-0836-2018·2018-03-14

    Stryker AHTO Tube Set Recalled for High Bioburden Levels

    Stryker is recalling AHTO Tube Sets labeled sterile because routine testing found bioburden levels higher than internal acceptable rates.

    Product
    STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0622-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Institutional, Inc. is recalling 1,527 cartons of Atorvastatin Calcium 10 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0618-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 10 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0621-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets, 80 mg, due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0619-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0620-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 40 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide