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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36876–36900 of 40449

  • ModerateFDA (Devices)·Z-0575-2014·2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. These screws are used to secure anterior cervical plates.

    Product
    Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2014·2014-01-01

    SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect

    SpineFrontier is recalling four PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.

    Product
    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0564-2014·2014-01-01

    Ziehm Vision C-Arm X-Ray Systems Recalled for Emergency Switch Issue

    Ziehm Imaging Inc is recalling 60 Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.

    Product
    Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0566-2014·2014-01-01

    Ziehm Vision FD C-Arm X-Ray System Recalled for Emergency Switch Change

    Ziehm Imaging Inc is recalling one Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System because an engineering change made the emergency switch an optional component.

    Product
    Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0579-2014·2014-01-01

    OrthoPediatrics ACL Sleeve Installation Tool Recall for Incorrect Size Etching

    OrthoPediatrics Corp is recalling 40 ACL Sleeve Installation Tools that may be etched with the wrong size. The tools were shipped in November 2013.

    Product
    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0571-2014·2014-01-01

    Data Innovations Instrument Manager Driver Software Recall for Sysmex UF-100

    Data Innovations is recalling Instrument Manager driver software for the Sysmex UF-100 analyzer due to potential sample errors.

    Product
    Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0563-2014·2014-01-01

    Ziehm Solo C-Arm X-Ray System Recalled for Emergency Switch Option

    Ziehm Imaging Inc is recalling 58 Solo C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.

    Product
    Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0569-2014·2014-01-01

    Siemens IMMULITE Folic Acid Kits Recalled for Potential Expiration Issues

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE Folic Acid kits due to a potential accelerated decline in counts that may cause failed adjustments before expiration.

    Product
    IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0555-2014·2014-01-01

    SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect

    SpineFrontier, Inc. is recalling 13 PedFuse Reset Screw Inserters because they may not mate properly with the hex interface of the screws.

    Product
    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0562-2014·2014-01-01

    Ziehm Vista C-Arm X-Ray Systems Recalled for Emergency Switch Change

    Ziehm Imaging Inc is recalling 83 Vista and Vista Plus C-Arm X-Ray systems because an engineering change made the emergency switch an option rather than a standard component.

    Product
    Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0554-2014·2014-01-01

    SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect

    SpineFrontier, Inc. is recalling 25 PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.

    Product
    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0573-2014·2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling 993 Indus Invue screws used in cervical spine surgery because they are mismarked or unmarked.

    Product
    Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0574-2014·2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling 922 Indus Invue Screws because they are mismarked or unmarked. These screws are used to secure anterior cervical plates.

    Product
    Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0560-2014·2014-01-01

    Edwards Lifesciences Recalls Mislabelled Ergonic Double Acting DeBakey Forceps

    Edwards Lifesciences is recalling three units of Ergonic Double Acting DeBakey Forceps due to incorrect laser etching that misidentified the instrument type.

    Product
    Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0488-2014·2013-12-25

    Nephros SafeShower and SafeSpout Water Filters Recalled for Marketing Violations

    Nephros Inc. is recalling SafeShower and SafeSpout water filters because promotional materials marketed them as medical devices.

    Product
    1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0485-2014·2013-12-25

    Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Results

    Abbott Diabetes Care is recalling specific lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.

    Product
    FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0472-2014·2013-12-25

    GE Healthcare Recalls Multi Absorber Original Devices Due to Air Leakage

    GE Healthcare is recalling Multi Absorber Original, Disposable devices due to a potential safety issue involving air leakage associated with the CO2 Multi Absorber.

    Product
    Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0487-2014·2013-12-25

    Nephros SafeSpout Water Filters Recalled for Improper Medical Device Marketing

    Nephros Inc. is recalling SafeSpout water filters because promotional materials made claims that marketed the non-medical products as medical devices.

    Product
    Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0540-2014·2013-12-25

    Smiths Medical Recalls Medfusion 4000 Syringe Infusion Pumps for Electrical Shorting

    Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps because conductive fluids entering the AC power receptacle can cause electrical shorting, sparking, or flames.

    Product
    Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0486-2014·2013-12-25

    Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Low Results

    Abbott Diabetes Care is recalling certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.

    Product
    FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0490-2014·2013-12-25

    Nephros Dual Stage Ultra Filter Brochure Recalled for Misleading Medical Claims

    Nephros Inc is recalling brochures for its Dual Stage Ultra Filter because the materials promoted the product as a medical device.

    Product
    Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2014·2013-12-25

    Baxter ABACUS TPN Calculation Software Recalled for Data Corruption Risk

    Baxter is voluntarily correcting ABACUS TPN software versions 2.0-3.0 because data corruption could cause patients to receive another patient's TPN order.

    Product
    ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2014·2013-12-25

    Remel Inc. Recalls Streptex Latex D Reagent for False Negative Results

    Remel Inc. is recalling 109 kits of Streptex Latex D reagent because the product may produce weak or false negative test results for streptococcal group D.

    Product
    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2014·2013-12-25

    GE Recalls InstaTrak and ENTrak Computer-Assisted Navigation Systems

    GE OEC Medical Systems is recalling InstaTrak and ENTrak navigation systems due to potential safety issues.

    Product
    InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
    Category
    Medical Device
    Distribution
    Distributed nationwide