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

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19651–19675 of 27682

  • HighFDA (Devices)·Z-2133-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2017·2017-05-31

    Merge Cardio software recalled for incorrect fetal measurement data retrieval

    Merge Healthcare is recalling Merge Cardio software versions 10.0 through 10.1.2 because the software may display incorrect fetal measurements by pulling data from prior pregnancies.

    Product
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2141-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2017·2017-05-31

    Stryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk

    Stryker is recalling Hoffmann LRF Safety Clips because they may loosen from the Quick Release mechanism on Transport Struts.

    Product
    Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2038-2017·2017-05-24

    Abbott NC Traveler RX Coronary Dilatation Catheter Recall for Balloon Sheath Issues

    Abbott Vascular is recalling NC Traveler RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2037-2017·2017-05-24

    Abbott NC Trek RX Coronary Dilatation Catheter Recall for Sheath Removal Issues

    Abbott Vascular is recalling NC Trek RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2112-2017·2017-05-24

    Sorin Defibrillators Recalled for Undetectable Battery Depletion

    Sorin is recalling specific defibrillator models because battery depletion may be undetectable. Physicians are being notified to check affected devices.

    Product
    OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2113-2017·2017-05-24

    Sorin Defibrillators Recalled for Undetectable Battery Depletion

    Sorin Group is recalling specific implantable defibrillators because battery depletion may be undetectable, posing a risk to patients.

    Product
    PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2039-2017·2017-05-24

    Abbott NC Tenku RX Balloon Catheter Recall for Sheath Removal Issues

    Abbott Vascular is recalling NC Tenku RX PTCA Balloon Catheters because the protective sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2097-2017·2017-05-24

    Ion Beam Applications Recalls Two Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 proton therapy systems in Florida because the device may restart irradiation from the beginning after a pause instead of recalculating the dose.

    Product
    Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1926-2017·2017-05-24

    Magellan LeadCare Ultra Blood Lead Test Kits Recalled for Inaccurate Results

    Magellan Diagnostics is recalling LeadCare Ultra Blood Lead Test Kits because they may generate falsely low lead concentrations when used with specific Becton Dickinson EDTA Vacutainer tubes.

    Product
    Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1925-2017·2017-05-24

    Magellan LeadCare Blood Analyzer Recall for Falsely Low Lead Results

    Magellan Diagnostics is recalling LeadCare Ultra Blood Analyzers because they may generate falsely low lead concentrations when used with specific Becton Dickinson collection tubes.

    Product
    Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1898-2017·2017-05-24

    ReFlow Medical Recalls Wingman 35 Crossing Catheters Due to Tip Detachment Risk

    ReFlow Medical is recalling Wingman 35 Crossing Catheters because they may be prone to tip detachment. The recall affects 2,794 units distributed in the US and internationally.

    Product
    Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2061-2017·2017-05-24

    Philips V60 Ventilators Recalled for Connector Pin Displacement

    Respironics is recalling 30,516 Philips V60 Ventilators because low-frequency vibrations can displace connector pins, causing momentary data transmission failures.

    Product
    Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2114-2017·2017-05-24

    Sorin Defibrillators Recalled for Undetectable Battery Depletion

    Sorin Group is recalling 37 implanted defibrillators because battery depletion may be undetectable. Physicians are being notified to monitor affected patients.

    Product
    INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2017·2017-05-24

    Spacelabs Arkon Anesthesia Delivery System Canister Carrier Recall

    Del Mar Reynolds Medical is recalling 62 Spacelabs Arkon Anesthesia Delivery System components because the canister carrier can break, causing a breathing circuit leak and potential patient hypoventilation.

    Product
    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2077-2017·2017-05-24

    Ortho-Clinical enGen Laboratory Automation Systems Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems due to a software anomaly that may cause sample ID misassociation, potentially leading to misdiagnosis.

    Product
    enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-2091-2017·2017-05-24

    Vortran VARPlus Automatic Resuscitator Recalled Due to Connector Assembly Error

    Vortran is recalling 35 cases of VARPlus Automatic Resuscitators because a connector was assembled in the reverse direction, preventing it from screwing onto the oxygen tubing.

    Product
    VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2087-2017·2017-05-24

    Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage

    Aesculap Implant Systems LLC is recalling 608 ELAN 4 diamond burrs because particulates may break off and enter the surgical site, potentially causing foreign body reactions or tissue damage.

    Product
    GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; GP166R; ELAN 4…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2017·2017-05-24

    Aesculap Hi-Line XS Diamond Burrs Recalled for Particulate Breakage Risk

    Aesculap Implant Systems LLC is recalling 608 Hi-Line XS Diamond Burrs because diamond particulates may break off and fall into the surgical site, potentially causing foreign body reactions or soft tissue damage.

    Product
    GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; GE626SU; HI-LINE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2017·2017-05-24

    BioMerieux Recalls ETEST ETP32 Ertapenem Strips Due to False Results

    BioMerieux SA is recalling ETEST ETP32 (Ertapenem) strips because they may produce false susceptible results, potentially leading to incorrect antibiotic treatment.

    Product
    ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2111-2017·2017-05-24

    Zimmer Werber Countersink Instruments Recalled Due to Material Defect

    Zimmer GmbH is recalling Werber Countersink instruments because raw material defects caused device damage.

    Product
    Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the…
    Category
    Medical Device
    Distribution
    0 states