The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

8951–8975 of 29123

  • SevereFDA (Devices)·Z-0372-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0344-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip prosthesis cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0326-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0059-2021·2020-11-11

    PD-Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    PD-Rx Pharmaceuticals is recalling 1,683 bottles of Metformin Hydrochloride Extended Release 500 mg because of NDMA impurity levels above acceptable limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    16 states
  • SevereFDA (Drugs)·D-0056-2021·2020-11-11

    Denton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Denton Pharma, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to the detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0338-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0375-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0345-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 57 mm Item Number: 00-8065-554-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0399-2021·2020-11-11

    Cook Inc. Recalls Fixed Core Wire Guides Due to Manufacturing Defects

    Cook Inc. is recalling 61 Fixed Core Wire Guides that may be bent or contain loose foreign matter due to being dropped during manufacturing.

    Product
    Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0330-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0067-2021·2020-11-11

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because the NDMA impurity level exceeds acceptable intake limits.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0333-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cup Components Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0373-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cup Components Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0346-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0062-2021·2020-11-11

    Metformin Hydrochloride Extended Release Tablets Recalled for NDMA Impurity

    Marksans Pharma Limited is recalling Metformin Hydrochloride Extended Release tablets due to N-Nitrosodimethylamine (NDMA) impurity levels above acceptable intake limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0335-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0061-2021·2020-11-11

    Time-Cap Labs Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Time-Cap Labs, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 500 mg because the FDA detected the impurity N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0068-2021·2020-11-11

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling 20,872 bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0060-2021·2020-11-11

    PD-Rx Recalls Metformin Hydrochloride Extended Release Tablets Due to NDMA

    PD-Rx Pharmaceuticals is recalling 125 bottles of Metformin Hydrochloride Extended Release tablets because of NDMA impurity levels above acceptable limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    16 states
  • SevereFDA (Drugs)·D-0058-2021·2020-11-11

    Direct Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    Direct Rx is recalling 88 bottles of Metformin Hydrochloride Extended Release 500 mg in Florida due to NDMA impurity levels above acceptable intake.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereCPSC·21024·2020-11-10

    Kohl's Recalls SONOMA Goods For Life Three-Wick Candles Due to Fire Hazards

    Kohl's is recalling approximately 512,000 SONOMA Goods For Life three-wick candles because high flames can ignite wax or break glass, posing fire and burn risks.

    Product
    SONOMA Goods For Life branded three-wick candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·21027·2020-11-10

    Sunjoy Oakmont LP Fire Pit Tables Recalled for Fire Hazard

    Sunjoy is recalling Oakmont LP fire pit tables sold at Big Lots because an incorrectly installed hose can melt and ignite, posing a fire hazard.

    Product
    Oakmont LP fire pit tables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V692000·2020-11-10

    Ford Recalls Explorer, Taurus, and Edge for Drive Axle Bracket Failure

    Ford is recalling 2014-2016 Explorer, 2014-2015 Taurus, and 2014 Edge vehicles because a front drive axle bracket may fail, risking loss of park function or motive power.

    Product
    FORD — FORD EXPLORER, TAURUS, EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V695000·2020-11-10

    2021 Winnebago Micro Minnie Trailers Undersized Axles Recall

    Winnebago is recalling certain 2021 Micro Minnie trailers equipped with undersized axles that may break under the vehicle's weight, potentially causing serious injury or death.

    Product
    WINNEBAGO — WINNEBAGO MICRO MINNIE
    Category
    Vehicle
    Distribution
    Distributed nationwide