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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Minimum severity

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

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21801–21825 of 40339

  • ModerateFDA (Devices)·Z-0444-2019·2018-11-21

    Espiner Tissue Retrieval System Recalled for Incorrect Volume Labeling

    Espiner Medical Ltd is recalling 230 units of the Eco-Sac Tissue Retrieval System because the label incorrectly states the volume is 1200 ml instead of 1000 ml.

    Product
    Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0455-2019·2018-11-21

    Straumann Recalls Neodent GM Mini Conical Abutments Due to Label Mismatch

    Straumann Manufacturing is recalling 21 units of Neodent GM Mini Conical Abutments because the laser-engraved label does not match the item in the package.

    Product
    Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0446-2019·2018-11-21

    BioFire FilmArray Meningitis/Encephalitis Panel Recalled for False Positive Risk

    BioFire Diagnostics is recalling specific FilmArray Meningitis/Encephalitis (ME) Panel kits due to a manufacturing issue that may cause elevated rates of false positive results for HSV-1.

    Product
    -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0458-2019·2018-11-21

    Siemens ARTIS Q Biplane Recalled for C-Arm Vibration Issues

    Siemens is recalling 54 ARTIS Q biplane x-ray systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.

    Product
    ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0414-2019·2018-11-21

    Collagen Matrix Recalls BioMend Extend Due to Potential Packaging Error

    Collagen Matrix, Inc. is recalling 569 units of BioMend Extend synthetic bone grafting material because the product may have been packaged in the wrong box.

    Product
    BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0269-2019·2018-11-14

    OriGen Reinforced Dual Lumen Cannula Recalled for Potential Tube Separation

    OriGen Biomedical is recalling 134 units of the VV19F Reinforced Dual Lumen Cannula because the extension tube may separate from the hub, posing a risk of blood loss.

    Product
    REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0360-2019·2018-11-14

    Roche CoaguChek XS Prothrombin Time Test Strips Recalled for High INR Results

    Roche Diagnostics is recalling CoaguChek XS Prothrombin Time test strips nationwide because they may produce abnormally high INR results.

    Product
    CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0391-2019·2018-11-14

    Oscor TB Series Bipolar Pacing Leads Recalled for Connector Sliding

    Oscor, Inc. is recalling TB Series Bipolar Pacing Leads because the connector cap housing may slide, potentially exposing the connection wire and causing loss of pacing.

    Product
    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0398-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling 6,180 units of the RapidFlap SpinDown Clamp because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2019·2018-11-14

    GE Healthcare Recalls Centricity Universal Viewer Due to Synchronization Failure

    GE Healthcare is recalling 73 Centricity Universal Viewer units because a synchronization failure may affect the display of medical images.

    Product
    Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0395-2019·2018-11-14

    Zimmer Biomet RapidFlap SpinDown Clamp Recalled for Assembly Error

    Zimmer Biomet is recalling 23,726 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2019·2018-11-14

    AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure

    AROA Biosurgery is recalling 8,853 boxes of Endoform Dermal Template 2x2 due to a potential pouch seal failure that could compromise sterility.

    Product
    Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2019·2018-11-14

    Cordis POWERFLEX PRO PTA Dilatation Catheter Recalled for Burst Strength Failure

    Cordis Corporation is recalling 162 units of POWERFLEX PRO PTA Dilatation Catheters because they may not meet internal manufacturing burst strength specifications.

    Product
    Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error

    Zimmer Biomet is recalling 3,246 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling 11,580 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The devices are used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2019·2018-11-14

    BD Nexiva IV Catheter Recall Due to Needle Shield Failure

    Becton Dickinson is recalling 133,230 units of BD Nexiva Closed IV Catheter Systems because a needle shield defect may increase the risk of contaminated needlestick injuries.

    Product
    BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) (see Figure below) incorporates a passive needle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2019·2018-11-14

    Siemens Dimension Thermal Chamber Motor Cable Recall for Insulation Defect

    Siemens is recalling 277 Dimension thermal chamber motor cables worldwide due to single insulation instead of required double insulation, posing a potential electrical shock risk.

    Product
    Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0393-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error

    Zimmer Biomet is recalling 12,825 units of the RapidFlap System 12mm SpinDown Clamp because the nut was assembled incorrectly. The defect affects sterile clamps used for craniotomy bone flap re-attachment.

    Product
    Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2019·2018-11-14

    Becton Dickinson Recalls PCEA Administration Sets Due to Potential Leaks

    Becton Dickinson is recalling PCEA Administration Sets because they may leak at the connection point. The recall covers 566,737 units distributed worldwide.

    Product
    PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2019·2018-11-14

    Medtronic CareLink 2090 Programmer Recalled for Software Vulnerability

    Medtronic is recalling CareLink 2090 Programmers worldwide due to a vulnerability that allows unauthorized software updates during the SDN download process.

    Product
    Medtronic CareLink 2090 Programmer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0373-2019·2018-11-14

    Howmedica Recalls 15 Pouches of Sterile Knee Instruments Due to Barrier Risk

    Howmedica Osteonics Corp. is recalling 15 pouches of sterile knee instruments because the outer sterile barrier may be compromised.

    Product
    Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0408-2019·2018-11-14

    Accuray Recalls CyberKnife M6 Systems Due to Wrist Component Failure Risk

    Accuray is recalling 93 CyberKnife M6 systems worldwide due to manufacturing variations in the robot wrist that may cause premature component failure.

    Product
    CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0386-2019·2018-11-14

    Becton Dickinson Recalls PCEA ASV Yellow Microbore Administration Sets

    Becton Dickinson is recalling PCEA ASV Yellow Microbore administration sets because they may leak at the luer lock connection.

    Product
    PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0394-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The defect affects 11,736 units distributed worldwide.

    Product
    Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide