The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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22501–22525 of 40299

  • ModerateFDA (Devices)·Z-3190-2018·2018-09-26

    Siemens ARTIS Pheno X-Ray System Recalled for Temperature Control Defect

    Siemens is recalling 429 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool below its designed operating range.

    Product
    ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3199-2018·2018-09-26

    Arrow International Recalls PICC Kits Due to Incorrect Catheter Inclusion

    Arrow International is recalling specific PICC kits because they may contain the wrong catheter type, potentially delaying patient treatment.

    Product
    4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-3179-2018·2018-09-26

    bioMerieux Recalls VITEK 2 AST-P640 Cards Due to Gentamicin Error

    bioMerieux is recalling VITEK 2 AST-P640 cards because some lots contain insufficient gentamicin, potentially affecting high-level resistance test results.

    Product
    VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3182-2018·2018-09-26

    Mako Surgical Recalls RIO Standard System Components for Connection Errors

    Mako Surgical Corporation is recalling 910 units of the Makoplasty RIO Standard System and Ethernet to Fiber Optic Converter due to communication-connection errors.

    Product
    Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3197-2018·2018-09-26

    Arrow Bipolar Electrode Catheter Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 7 units of a specific bipolar electrode catheter lot because they are labeled with an incorrect expiration date.

    Product
    ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2767-2018·2018-09-26

    Foley Catheter with Temperature Sensor Recalled for Defective Sensors

    Degania Silicone is recalling 12,532 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3189-2018·2018-09-26

    Siemens Artis Q X-Ray Systems Recalled for Temperature Control Defect

    Siemens is recalling 429 Artis Q Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool down outside its designed working range.

    Product
    Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3176-2018·2018-09-26

    Zimmer Biomet Recalls Commingled Gentle Thread PLGA Interference Screws

    Zimmer Biomet is recalling 52 Gentle Thread PLGA Round Head Interference Screws because they were commingled with a different screw size.

    Product
    Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-3185-2018·2018-09-26

    Polymedco PATHFAST Myoglobin II Cartridges Recalled for Leakage

    Polymedco is recalling 272 PATHFAST Myoglobin II reagent cartridges due to a pinhole defect that may cause measurement bias.

    Product
    PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized…
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-3184-2018·2018-09-26

    Ortho-Clinical VITROS Chloride Slides Recalled for Analytical Performance Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they failed to meet performance standards for urine samples.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3193-2018·2018-09-26

    Ortho-Clinical VITROS Chemistry CREA Slides Recalled for Measurement Accuracy Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides because they failed to meet accuracy standards for low-end creatinine measurements in serum and urine.

    Product
    VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3196-2018·2018-09-26

    Smiths Medical Recalls Mislabeled Arterial Blood Sampling Kits

    Smiths Medical ASD Inc. is recalling 29,600 Portex Pulsator Arterial Blood Sampling Kits because they were mislabeled with incorrect labels.

    Product
    Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3132-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail 130¿ 13 mm x 180 mm, Item Number: 814513180
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3074-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 400 mm, Item Number: 814313400
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3161-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 440 mm, Item Number: 814611440
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3086-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 420 mm, Item Number: 814409420
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3155-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 320 mm, Item Number: 814611320
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3048-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 300 mm, Item Number 814309300
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3069-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 300 mm, Item Number: 814313300
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3090-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 320 mm, Item Number: 814411320
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3087-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 440 mm, Item Number: 814409440
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3070-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 320 mm, Item Number: 814313320
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3166-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 320 mm, Item Number: 814613320
    Category
    Medical Device
    Distribution
    42 states