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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37276–37300 of 40449

  • HighFDA (Devices)·Z-0171-2014·2013-11-13

    Handicare Bath Bliss Handset Recall for Inoperable Lifts

    Handicare Accessibility is recalling 3,301 handsets for Minivator Bath Bliss Reclining Bath Lifts because two units became inoperable while users were in the tub.

    Product
    Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) Handset component devices operate the Minivator Bath Bliss Reclining Bath…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2014·2013-11-13

    Portex Spinal Trays Recalled Due to Visual Particulate in Lidocaine Ampules

    Smiths Medical ASD is recalling 73 Portex Spinal Trays because visual particulate was found in the included Lidocaine HCL ampules.

    Product
    Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2014·2013-11-13

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Hematology Analyzers

    Beckman Coulter is recalling 1,025 UniCel DxH 800 and DxH 600 hematology analyzers because specific check valves may fail, potentially causing air or liquid leaks.

    Product
    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2014·2013-11-13

    Siemens Fluoroscopic X-Ray Systems Recalled for Potential Radiation Malfunction

    Siemens is recalling 23 fluoroscopic X-ray systems due to a potential malfunction that may cause radiation to continue longer than expected, resulting in unnecessary dose.

    Product
    Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical ASD, Inc. is recalling Portex Spinal Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2014·2013-11-13

    Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure

    Ethicon Endo-Surgery Inc is recalling 2,475 Adjustable Gastric Bands because aging studies showed they failed to meet Force to Lock test requirements.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2014·2013-11-13

    Edwards Lifesciences Recalls Fem-Flex Femoral Arterial Cannulas Due to Cracks

    Edwards Lifesciences is recalling two lots of Fem-Flex Femoral Arterial Cannulas because cracks were found in the t-connectors during product evaluation.

    Product
    Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0154-2014·2013-11-13

    Medtronic Resolute Integrity Coronary Stent Recall for Incorrect Compliance Chart Labeling

    Medtronic is recalling 201 units of Resolute Integrity Zotarolimus-eluting Coronary Stents because the compliance chart may incorrectly reference a 2.25 mm diameter instead of the correct 3.0 mm.

    Product
    Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0179-2014·2013-11-13

    Carestream DRX-Revolution Mobile X-Ray Systems Software Patch Recall

    Carestream Health is voluntarily installing a software patch on DRX-Revolution mobile X-ray systems to address reports of non-diagnostic images during normal exposure exams.

    Product
    DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0132-2014·2013-11-13

    Carestream DRX Revolution Mobile X-Ray System Column Cover Recall

    Carestream Health is recalling DRX Revolution mobile x-ray systems because the column end cover may dislodge from the column.

    Product
    DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0136-2014·2013-11-13

    Bayer A1CNow+ Test Kits Recalled for Potential Inaccurate Results

    Bayer is recalling A1CNow+ test kits because they may produce high-bias readings if stored at room temperature for 4 to 5 months.

    Product
    Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0137-2014·2013-11-13

    ITC Surgicutt Bleeding Time Device Recalled for Loose Blades

    ITC-Nexus Dx is recalling Surgicutt bleeding time devices because the blades may be loose. The recall affects Lot AK301M distributed nationwide.

    Product
    Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0130-2014·2013-11-13

    Smith & Nephew Recalls Mispackaged Genesis II Tibial Base Components

    Smith & Nephew is recalling four units of Genesis II tibial base components due to size and side mislabeling.

    Product
    GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0145-2014·2013-11-13

    Richard Wolf Recalls S(a)line Resectoscope Vaporization Electrodes Due to Packaging Error

    Richard Wolf Medical Instruments Corp. is recalling S(a)line resectoscope vaporization electrodes because a different model was found packaged in the wrong pouch.

    Product
    Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2014·2013-11-13

    Carestream DRX Mobile X-Ray Systems Recalled for Software Defect

    Carestream Health is voluntarily patching DRX Mobile X-Ray systems to fix a software issue causing non-diagnostic images.

    Product
    CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0165-2014·2013-11-13

    Insulet Recalls OmniPod Insulin Starter Kits Due to Mislabeling

    Insulet Corporation is recalling 1,719 OmniPod Insulin Management System Starter Kits because the included alcohol prep pads are not properly labeled.

    Product
    OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0159-2014·2013-11-13

    Smiths Medical Recalls Portex Regional Anesthesia Trays with Visual Particulates

    Smiths Medical is recalling Portex Regional Anesthesia Trays because visual particulates were found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0177-2014·2013-11-13

    Pinook Micro Massager Recalled for Lack of FDA Approval

    Pinook-Usa is recalling 28,994 Pinook Micro Massagers because the company failed to submit a premarket submission and gain FDA approval for the device.

    Product
    Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0162-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical is recalling Portex Spinal Anaesthesia Trays because some included glass ampules contain visual particulate matter.

    Product
    Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0155-2014·2013-11-13

    Trumpf Medical Systems Recalls ORBIT PT Patient Transport Device

    Trumpf Medical Systems is recalling one ORBIT PT unit due to a power supply defect that caused smoke and odor.

    Product
    ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0153-2014·2013-11-13

    Beckman Coulter ISE REF Valve Recall for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU480, AU680, and AU5800 analyzers due to premature valve failure that may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0129-2014·2013-11-13

    Zimmer Recalls Ti-Magna Fx Washers Due to Sterile Barrier Integrity Testing

    Zimmer, Inc. is recalling 2,632 Ti-Magna Fx Washers distributed in Japan to ensure sterile barrier integrity after a review of historic packaging validations.

    Product
    Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx¿ II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0156-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays Due to Visual Particulate

    Smiths Medical ASD, Inc. is recalling 140 Portex Spinal Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0152-2014·2013-11-13

    Beckman Coulter Recalls ISE REF Valves for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU series chemistry analyzers because premature valve failure may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2014·2013-11-13

    Insulet Recalls OmniPod Demonstration Kits Due to Mislabeling

    Insulet Corporation is recalling 5,050 OmniPod Insulin Management Product Demonstration Kits because the included alcohol prep pads are not properly labeled.

    Product
    OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel…
    Category
    Medical Device
    Distribution
    Distributed nationwide