The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

21726–21750 of 50426

  • HighFDA (Devices)·Z-0341-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the 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, 55 mm Item Number: 00-8065-552-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip prosthesis cups because the 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, 61 mm Number: 00-8065-658-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2021·2020-11-11

    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. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0332-2021·2020-11-11

    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. 32mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0383-2021·2020-11-11

    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, 59 mm Number: 00-8065-656-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Acetabular Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 hip prosthesis 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, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2021·2020-11-11

    3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

    3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

    Product
    3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0377-2021·2020-11-11

    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. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant 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. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2021·2020-11-11

    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. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0325-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 hip prosthesis 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. 26 mm, Neutral, O.D. Cup with Spacers, 45mm Item Number: 00-8065-542-26 Hip prosthesis component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2021·2020-11-11

    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. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0389-2021·2020-11-11

    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 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, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns

    Zimmer Biomet is recalling specific 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. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2021·2020-11-11

    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. 32 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2021·2020-11-11

    3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

    3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

    Product
    3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components

    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, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling specific acetabular cup hip prosthesis 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. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 43 mm Number: 00-8065-640-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0349-2021·2020-11-11

    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, 59 mm Number: 00-8065-556-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0314-2021·2020-11-11

    GE Healthcare Recalls 9100c NXT Systems Due to Flow Sensor Defects

    GE Healthcare is recalling 37 9100c NXT systems because flow sensors may have damaged tubes with small punctures or cuts.

    Product
    9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0354-2021·2020-11-11

    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. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components

    Zimmer Biomet is recalling 412 acetabular cup hip prosthesis 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. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0324-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling specific ZCA All Poly Acetabular Cup hip prosthesis 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. 22 mm, Neutral, O.D. Cup with Spacers, 45mm Item Number: 00-8065-542-22 Hip prosthesis component
    Category
    Medical Device
    Distribution
    Distributed nationwide