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.

28376–28400 of 50488

  • HighFDA (Drugs)·D-0899-2018·2018-07-11

    SCA Pharmaceuticals Recalls Norepinephrine Bitartrate Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate 8 mg bags due to a potential for leakage that compromises sterility.

    Product
    Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2375-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but risks include surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2292-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling specific LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.

    Product
    LFIT Anatomic CoCr Femoral Heads, 6260-9-036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about disassociation from the hip stem.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2296-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling 58 M/L Taper Hip Prostheses distributed to Japan due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5; 00-7713-007-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2371-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue may be present in the packaging.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5; 00-7713-017-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2369-2018·2018-07-11

    Zimmer Biomet Recalls Hip Prostheses Due to Black Residue in Packaging

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging. The residue is a mix of titanium and polyethylene.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2365-2018·2018-07-11

    Zimmer Biomet Recalls 24 Hip Prosthesis Units Distributed to Japan

    Zimmer Biomet is voluntarily recalling 24 hip prosthesis units distributed solely to Japan. The recall was initiated in May 2018 and terminated in May 2020.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 10; 00-7713-010-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2373-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 due to black residue found in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 22.5; 00-7713-022-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2367-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling 84 M/L Taper Hip Prostheses with Kinective Technology due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2298-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2018·2018-07-11

    FHC Depth Stop Adapter Recall Due to Lead Damage Risk

    FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage the lead and stylet, potentially requiring surgical replacement.

    Product
    microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2341-2018·2018-07-11

    Intuitive Surgical Recalls da Vinci X Systems with Defective Arm Controller Boards

    Intuitive Surgical is recalling 35 da Vinci X Surgical Systems because defective Arm Controller Joint boards have a high rate of failure.

    Product
    da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0904-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling specific lots of Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL bags due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighNHTSA·18V465000·2018-07-11

    BMW and MINI Recall 5,309 Vehicles for Crankshaft Sensor Defect

    BMW is recalling 5,309 vehicles because a crankshaft sensor firmware error may cause the engine to stall, increasing crash risk.

    Product
    MINI — MINI, BMW JCW, X2, COUNTRYMAN, CLUBMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2337-2018·2018-07-11

    Terumo Recalls Angio-Seal Evolution Vascular Closure Devices

    Terumo Medical Corp is recalling 240 Angio-Seal Evolution Vascular Closure Devices because they were released before required validation was completed.

    Product
    Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-1604-2018·2018-07-11

    SNI Recalls Nitric Blast Products Containing Geranium Extract

    SNI, LLC is recalling Nitric Blast products containing geranium extract (DMAA) as a dietary ingredient.

    Product
    SNI Nitric Blast Sour Apple 276gr (UPC ending in 5581) --- The product is a powder marketed in a 276gr black bottle with a silver cap. The bottle prominently displays the product name "NITRIC BLAST" in silver and white letters on the front of a black label.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2343-2018·2018-07-11

    B. Braun Recalls 26-Lead Transfer Sets for Valve Orientation Defect

    B. Braun Medical is recalling 26-Lead Transfer Sets for the APEX Compounding System because valves may be incorrectly oriented, posing a risk of unintended admixture.

    Product
    26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2294-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044
    Category
    Medical Device
    Distribution
    Distributed nationwide