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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

29751–29775 of 40449

  • ModerateFDA (Devices)·Z-2157-2016·2016-07-20

    Synthes Recalls 4.5 mm Cannulated Screws Due to Labeling Errors

    Synthes (USA) Products LLC is recalling 4.5 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2155-2016·2016-07-20

    Synthes 4.0 mm Cortex Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 4.0 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2148-2016·2016-07-20

    Breathe Right Clear Nasal Strips Recalled for Incorrect Packaging Labels

    GSK Consumer Healthcare is recalling Breathe Right Clear nasal strips because some secondary packaging cartons were incorrectly labeled for the AU/NZ market.

    Product
    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2203-2016·2016-07-20

    Roche Recalls Influenza Quality Control Kits Due to Incorrect Expiration Dates

    Roche Molecular Systems is recalling 194 cobas Liat Influenza A/B Quality Control Kits because they are labeled with incorrect expiration dates.

    Product
    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
    Category
    Medical Device
    Distribution
    16 states
  • LowFDA (Devices)·Z-2143-2016·2016-07-20

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling 30 enGen Laboratory Automation Systems due to a software error that displays incorrect interpretive text for certain test results.

    Product
    enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2145-2016·2016-07-20

    Ortho VITROS AFP Reagent Pack Recall Due to Calibration Failure

    Ortho Clinical Diagnostics is recalling specific lots of VITROS AFP Reagent Packs because they may fail to calibrate, potentially affecting test results.

    Product
    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2122-2016·2016-07-13

    Medtronic Recalls Cytosponge Cell Collection Kits Due to Detachment Reports

    Medtronic is recalling Cytosponge Cell Collection Kits after two reports of the device detaching from the removal string during withdrawal from the esophagus.

    Product
    Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the…
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1908-2016·2016-07-13

    Hummingbird Med Recalls Hummi Micro Draw Blood Transfer Devices

    Hummingbird Med is recalling 62,400 Hummi Micro Draw Blood Transfer Devices distributed in California due to insertion difficulties.

    Product
    ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2134-2016·2016-07-13

    Karl Storz Image1 SPIES X-LINK Camera Control Unit Recall

    Karl Storz Endoscopy is recalling Image1 SPIES X-LINK Camera Control Units due to potential electrical interference when used with specific camera heads and mediastinoscopes.

    Product
    Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2124-2016·2016-07-13

    Esaote G-scan Brio MRI System Recalled for Table Fracture Risk

    Esaote S.p.A. is recalling G-scan Brio MRI systems because dynamic loading forces from larger patients can fracture the patient table's extremity portion.

    Product
    Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2131-2016·2016-07-13

    GE Healthcare Recalls Discovery MR750w MRI Scanners Due to Burn Risk

    GE Healthcare is recalling 471 Discovery MR750w MRI scanners because a small area of the patient bore can become warm enough to cause a serious burn if proper padding is not used.

    Product
    GE Healthcare, Discovery MR750w
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-2129-2016·2016-07-13

    Medtronic PoleStar MRI System Components Recalled for Electrical Shock Risk

    Medtronic Navigation is recalling PoleStar MRI system components due to misplaced ground pins that may cause electrical shock to users.

    Product
    PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2016·2016-07-13

    Medtronic 0-arm Imaging mobile x-ray system recall for battery damage risk

    Medtronic is recalling 0-arm Imaging mobile x-ray systems because replacement batteries may be damaged during shipment, creating a risk of failure.

    Product
    Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2016·2016-07-13

    Toshiba Vantage Titan 3T MRI System Recalled for Gradient Coil Issue

    Toshiba American Medical Systems is recalling 33 Vantage Titan 3T MRI systems due to a potential problem with the gradient coil.

    Product
    MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2016·2016-07-13

    Custom Ultrasonics System 83 Plus Endoscope Washer Recall Issued

    Custom Ultrasonics is recalling System 83 Plus endoscope washer/disinfectors to warn customers not to use them for duodenoscopes until further notice.

    Product
    The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2016·2016-07-13

    Medtronic Recalls Cytosponge Cell Collection Device Due to Detachment Reports

    Medtronic is recalling the Cytosponge Cell Collection Device after two reports of the device detaching from its removal string during withdrawal from the esophagus.

    Product
    Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2125-2016·2016-07-13

    Medtronic Recalls MyCareLink Patient Monitor Due to Data Transmission Failure

    Medtronic is recalling 262 MyCareLink Patient Monitors because a software update prevents implanted device data from reaching clinicians, despite appearing successful to patients.

    Product
    Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2126-2016·2016-07-13

    Anspach Effort Recalls Battery Oscillators with Incorrect Mode Switch Labels

    The Anspach Effort, Inc. is recalling 20 Battery Power Line II Battery Oscillators because the mode switch ring has incorrect operating directions.

    Product
    Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2133-2016·2016-07-13

    Cadillac First Aid Kit Recalled for Prescription-Only CPR Mask

    Lifeline First Aid LLC is recalling Cadillac First Aid Kits because they contain a CPR mask cleared only for prescription use, not over-the-counter.

    Product
    5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2136-2016·2016-07-13

    Arrow Recalls Central Venous Catheters Due to Length Mismatch

    Arrow International Inc. is recalling specific lots of central venous catheters because kits labeled for 20 cm catheters may contain 16 cm catheters.

    Product
    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2137-2016·2016-07-13

    Ergoactives Recalls HeaterBaum Foot and Ankle Heating Pads

    Ergoactives is recalling 278 HeaterBaum Foot & Ankle Heating Pads because they were marketed without a cleared 510(k).

    Product
    HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2004-2016·2016-07-13

    Musculoskeletal Transplant Foundation Recalls AFT Diverted Tubes Due to Unsealed Pouch

    Musculoskeletal Transplant Foundation is recalling 114 AFT Diverted Tubes because an unsealed Tyvek pouch could introduce contamination into the sterile field.

    Product
    Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2016·2016-07-13

    Lifeline CPR Rescue Kits Recalled for Prescription-Only Mask Component

    Lifeline First Aid LLC is recalling CPR rescue kits because the included CPR shield mask is cleared only for prescription use, not over-the-counter.

    Product
    Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red…
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2120-2016·2016-07-13

    ZYTO Technologies Recalls ZYTO Tower and Software for Regulatory Violations

    ZYTO Technologies is voluntarily recalling ZYTO Tower devices and software because their marketing claims exceeded the scope of their FDA 510(k) clearance.

    Product
    The ZYTO Tower is the input device to program the software with various virtual items.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2138-2016·2016-07-13

    Synthes Ti Button Plate Recalled for Inaccurate MR Safety Labeling

    Synthes (USA) Products LLC is recalling 6,255 Ti Button Plate units because their MR safety information does not meet current ASTM standards.

    Product
    Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
    Category
    Medical Device
    Distribution
    50 states