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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18476–18500 of 40124

  • HighFDA (Devices)·Z-0922-2020·2020-02-05

    Roche Cobas infinity Software Recalled for Incorrect Alarm Mapping

    Roche Diagnostics is recalling 20 Cobas infinity software modules due to incorrect alarm mapping. The software versions 2.4.1 through 2.5.4 are affected.

    Product
    Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2020·2020-02-05

    Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk

    Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete washing.

    Product
    CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2020·2020-02-05

    Vitreq Recalls VitreQ 20G VFI Cannulas Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 20G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2020·2020-02-05

    ROi CPS Recalls Custom Procedure Packs Containing Recalled Clearlink Devices

    ROi CPS LLC is recalling 412 custom procedure packs containing Clearlink Continu-Flo devices that were previously recalled by Baxter Healthcare Corporation.

    Product
    Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0917-2020·2020-02-05

    Bard Conquest 40 PTA Dilation Catheter Recalled for Packaging Error

    Bard Peripheral Vascular Inc. is recalling 286 units of Conquest 40 PTA Dilation Catheters because packaging incorrectly listed the balloon size, posing a risk of vessel injury.

    Product
    Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0891-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ Bowl Kits Due to Leak Risk

    Haemonetics is recalling Cell Saver 5/5+ Bowl Kits because they may leak, trapping fluid and causing incomplete washing.

    Product
    Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2020·2020-02-05

    Zimmer Biomet Recalls ASI 2.0 Calcar Trimmer Shafts Due to Mating Failure

    Zimmer Biomet is recalling 67 units of ASI 2.0 Calcar Trimmer Shafts because the shaft end may fail to mate effectively with the broach.

    Product
    ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Potential Leaks

    Haemonetics is recalling Cell Saver bowl sets because cracks may cause leaks and incomplete blood washing.

    Product
    Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0847-2020·2020-02-05

    Vitreq 25G Blunt and Brush Needles Recalled for Sterility Risk

    Vitreq Bv is recalling VitreQ 25G Blunt and Brush Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0910-2020·2020-02-05

    Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended because they may have been packaged with incorrect Instructions for Use.

    Product
    GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0845-2020·2020-02-05

    Intuitive da Vinci SP Surgical System Cannula Mount Button Recall

    Intuitive Surgical is recalling five da Vinci SP surgical systems because the cannula mount button may be damaged if released abruptly.

    Product
    The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0862-2020·2020-02-05

    Siemens Atellica CH 930 Analyzer Recalled for Barcode Scanning Error

    Siemens is recalling 1,528 Atellica CH 930 Analyzers in 17 foreign countries because a barcode scanning error causes the system to use default values instead of specific fluid concentrations for Sodium, Potassium, and Chloride tests.

    Product
    Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0878-2020·2020-02-05

    Smith & Nephew Recalls Legion AP Cutting Blocks Due to Design Defect

    Smith & Nephew is recalling specific lots of LEGION AP Cutting Blocks because they were manufactured with an oversize green plunger hole, failing to meet design specifications.

    Product
    LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0873-2020·2020-02-05

    Exactech Equinoxe Humeral Stem Recalled for Incorrect Label Translation

    Exactech is recalling Equinoxe humeral stems because outer labels incorrectly described the standard-length implants as 'long' in non-English translations.

    Product
    Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0909-2020·2020-02-05

    Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane 6-9 because they may have been packaged with incorrect Instructions for Use.

    Product
    GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0883-2020·2020-02-05

    Synthes 2.4mm Sterile Locking Screw Recall Due to Packaging Defect

    Synthes is recalling 25 units of 2.4mm sterile locking screws because the inner packaging cap may open prematurely, potentially preventing the screw from being used during surgery.

    Product
    2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0882-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the inner packaging cap may open or fail to separate, potentially delaying surgery.

    Product
    2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0881-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the inner cap may open or the tube may remain in the outer cap, preventing screw removal.

    Product
    2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0907-2020·2020-02-05

    Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane 6-9 because they may have been packaged with incorrect Instructions for Use.

    Product
    GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0908-2020·2020-02-05

    GIBSON Healthcare Membrane Recalled for Incorrect Instructions for Use

    Collagen Matrix Inc is recalling GIBSON Healthcare Membrane 6-9 units because they may have been packaged with incorrect Instructions for Use.

    Product
    GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2020·2020-02-05

    GE Healthcare Recalls SIGNA Premier MRI Systems Due to Date Errors

    GE Healthcare is recalling 62 SIGNA Premier MRI systems because a potential installation issue could cause incorrect dates to be recorded on medical images.

    Product
    SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0912-2020·2020-02-05

    GIBSON Healthcare Membrane Extended Recalled for Incorrect Instructions for Use

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended because they may have been packaged with incorrect Instructions for Use.

    Product
    GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0911-2020·2020-02-05

    Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions

    Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended because they may have been packaged with incorrect Instructions for Use.

    Product
    GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0879-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the packaging may fail to keep the screw accessible, potentially delaying surgery.

    Product
    2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0880-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the packaging may fail to keep the screw sealed, potentially causing surgical delays.

    Product
    2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
    Category
    Medical Device
    Distribution
    Distributed nationwide