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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15476–15500 of 27471

  • HighFDA (Devices)·Z-2096-2019·2019-08-14

    Gk Photonics Logolas Laser Projectors Recalled for Safety Interlock Defect

    Gk Photonics is recalling Logolas Laser Projection Series units because the remote interlock dongle may not fully comply with FDA safety requirements, posing a risk of high-power laser exposure.

    Product
    Logolas Laser Projection Series
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2148-2019·2019-08-14

    Olympus MAJ-209 Single Use Suction Valves Recalled for Potential Malfunction

    Olympus is recalling MAJ-209 Single Use Suction Valves because they may come apart or remain stuck inside endoscopes.

    Product
    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2019·2019-08-14

    Fresenius Recalls Liberty Cycler Cassettes Due to Potential Solution Leakage

    Fresenius Medical Care is recalling Liberty Cycler Cassettes because damaged units may leak dialysis solution into the cycler, posing a contamination risk.

    Product
    Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2165-2019·2019-08-14

    Centurion Neonatal PICC Insertion Tray Recalled for Packaging Compromise

    Centurion Medical Products is recalling 120 Neonatal PICC Insertion Trays because the sterile packaging may be compromised, posing a risk of infection.

    Product
    NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2019·2019-08-14

    Integra LifeSciences Recalls Codman ISOCOOL Bipolar Forceps Due to Insulation Defect

    Integra LifeSciences is recalling 125 units of Codman ISOCOOL Bipolar Forceps because inadequate insulation coating may prevent proper tissue coagulation during surgery.

    Product
    Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2138-2019·2019-08-14

    MED-EL PULSARci100 Cochlear Implant Recalled for Leak Test Failures

    MED-EL is recalling PULSARci100 Cochlear Implants because they failed helium-fine leak tests. Affected devices were distributed in the US and several international countries.

    Product
    MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2019·2019-08-14

    Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues

    Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints of leaks, suction issues, and failure to obtain tissue samples.

    Product
    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2180-2019·2019-08-14

    Ortho VITROS 5600 Analyzer Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 89 VITROS 5600 clinical chemistry analyzers worldwide due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 5600 Integrated System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2088-2019·2019-08-07

    Qiagen Filter-Tips Recalled for Leaking During Sample Preparation

    Qiagen Sciences LLC is recalling specific lots of Filter-Tips used with QIAsymphony instruments because a small percentage of tips are leaking.

    Product
    Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2104-2019·2019-08-07

    Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Thermistor

    Terumo is recalling Capiox NX19 Oxygenators because they may contain a non-functioning arterial thermistor component.

    Product
    Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2127-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Caps Due to Inadequate Shielding

    Burlington Medical is recalling 49 radiation protection caps because the protective material may not adequately shield users from scatter radiation.

    Product
    Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2019·2019-08-07

    Siemens Stratus CS Acute Care cTNI TestPak Recalled for False Positives

    Siemens Healthcare Diagnostics Inc is recalling Stratus CS Acute Care cTNI TestPaks due to a potential for increased false positive results.

    Product
    Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2019·2019-08-07

    Burlington Medical Porta Shield Radiation Protection Recall

    Burlington Medical is recalling Porta Shield radiation protection products because the material may provide inadequate protection against scatter radiation.

    Product
    Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2019·2019-08-07

    Burlington Medical Recalls 129 Full Overlap Radiation Protection Vests and Kilts

    Burlington Medical is recalling 129 two-piece radiation protection vests and kilts because the protective material may provide inadequate shielding against scatter radiation.

    Product
    2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2126-2019·2019-08-07

    Burlington Medical Recalls Half Aprons Due to Potential Radiation Protection Deficiency

    Burlington Medical is recalling two half aprons because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to higher radiation levels.

    Product
    Half Apron, Product Number Half Apron, Part Numbers REHALF*, REHALF3 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2019·2019-08-07

    Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection

    Burlington Medical is recalling 807 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially increasing long-term health risks.

    Product
    Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4-T2T, SLTS4-R, UETS4-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Hoods Due to Inadequate Shielding

    Burlington Medical is recalling three radiation protection hoods because the protective material may not adequately shield users from scatter radiation.

    Product
    Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2124-2019·2019-08-07

    Burlington Medical Recalls Frontal Radiation Protection Aprons Due to Inadequate Shielding

    Burlington Medical is recalling Frontal Aprons with Quick Drop Velcro Closure because the protective material may provide inadequate protection against scatter radiation.

    Product
    Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2019·2019-08-07

    Encore Medical Recalls Flexible Drill Shafts Due to Manufacturing Error

    Encore Medical is recalling 21 Flexible Drill Shafts because a manufacturing error may prevent the shaft from capturing the drill bit pin, potentially causing the bit to come loose during surgery.

    Product
    Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2103-2019·2019-08-07

    Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Thermistor

    Terumo is recalling 78 Capiox NX19 Oxygenators exported to Japan and Belgium because they may contain a non-functioning arterial thermistor component.

    Product
    Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2102-2019·2019-08-07

    Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Thermistor

    Terumo is recalling 52 Capiox NX19 Oxygenators because they may contain a non-functioning arterial thermistor component.

    Product
    Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2120-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Aprons Due to Inadequate Shielding

    Burlington Medical is recalling two radiation protection aprons because the protective material may provide inadequate shielding, potentially exposing users to scatter radiation.

    Product
    1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Sleeves Due to Inadequate Shielding

    Burlington Medical is recalling 39 radiation protection sleeves because the material may provide inadequate protection against scatter radiation.

    Product
    Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2019·2019-08-07

    Burlington Medical Recalls Overlap Vests Due to Potential Inadequate Radiation Protection

    Burlington Medical is recalling seven Overlap Vests because the protective material may provide inadequate protection against scatter radiation.

    Product
    Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2019·2019-08-07

    Burlington Medical Recalls Lead Apron Products Due to Inadequate Radiation Protection

    Burlington Medical is recalling 332 lead apron products because the protective material may provide inadequate protection against scatter radiation.

    Product
    2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPVKE, UEPVK*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing…
    Category
    Medical Device
    Distribution
    Distributed nationwide