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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

22051–22075 of 27663

SevereFDA (Devices)·Z-1027-2016·2016-03-09
NeoCoil 3.0T GEM Flex Coil Recalled for Potential Burn Risk
NeoCoil, LLC is recalling 2,121 units of the 3.0T GEM Flex Coil system due to a potential for higher than specified surface temperatures that may result in patient warming or burns.
Product
NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1031-2016·2016-03-09
Mako Surgical Recalls Restoris Knee Implants Due to Packaging Damage
Mako Surgical Corporation is recalling 146 units of the Restoris Multicompartmental Knee System because damaged packaging may have compromised the sterile barrier.
Product
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1028-2016·2016-03-09
Cook Inc. Recalls Kopans Breast Lesion Localization Needles
Cook Inc. is recalling 134 Kopans Breast Lesion Localization Needles because they may have been exposed to body fluids during processing, posing a potential risk of blood-borne pathogen transmission.
Product
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2016·2016-03-09
Philips Recalls BrightView XCT Gamma Cameras Due to Mechanical Defects
Philips is recalling 427 BrightView XCT gamma cameras because the collimator may contact the patient pallet or the gantry may halt prematurely during scans.
Product
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2016·2016-03-09
Siemens Dimension Vista B2 Microglobulin Reagent Cartridge Recall
Siemens Healthcare Diagnostics is recalling Dimension Vista B2 Microglobulin reagent cartridges due to increased abnormal assay errors and calibration failures that may produce inaccurate patient results.
Product
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1026-2016·2016-03-09
Ivoclar Vivadent Recalls Helioseal Clear Pit and Fissure Sealant
Ivoclar Vivadent is recalling Helioseal Clear dental sealant because a production error may prevent the material from curing properly under specific lights.
Product
Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1025-2016·2016-03-09
Karman Healthcare Recalls Karma Flexx Wheelchairs Due to Incorrect Hardware
Karman Healthcare is recalling 35 Karma Flexx manual wheelchairs because incorrect size screws and hardware were installed on the front caster fork brackets.
Product
Karma Flexx Wheelchair Manual Wheelchair.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1044-2016·2016-03-09
ConvaTec Recalls Opti-Mist Nebulizer Masks Due to Reduced Aerosol Output
ConvaTec is recalling Opti-Mist and Opti-Mist Clear nebulizer masks because a component defect reduces or stops aerosol output, potentially preventing patients from receiving medication.
Product
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1045-2016·2016-03-09
Maquet Extension Device Recalled for Potential Detachment from Operating Table
Maquet is recalling the 1180.19F0 Extension Device because it may unlock and fall from the MAGNUS operating table.
Product
Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1029-2016·2016-03-09
Argon Medical Devices Recalls ClosureFast Introducer Sheath Sets Due to Assembly Error
Argon Medical Devices is recalling specific ClosureFast Introducer Sheath Sets because incorrect sheath lengths were assembled to the devices.
Product
ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1021-2016·2016-03-09
Philips Recalls BrightView X Gamma Cameras Due to Motion and Collision Issues
Philips Medical Systems is recalling 117 BrightView X gamma cameras worldwide due to potential gantry motion halts and collimator contact with the patient pallet.
Product
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0799-2016·2016-03-02
Cook Inc. Recalls Single Lumen Central Venous Catheter Sets
Cook Inc. is recalling 1,341 single-lumen central venous catheter sets and trays due to a manufacturing defect that may cause catheter tip fracture or separation.
Product
Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0921-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 326 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0798-2016·2016-03-02
Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Splits
Cook Inc. is recalling 9,519 Shuttle Select Slip-Cath Catheters worldwide due to reports of catheter tip splits and separation, which can cause loss of function or complications.
Product
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0827-2016·2016-03-02
Draeger Medical Recalls Evita and Babylog Ventilators Due to Battery Defect
Draeger Medical is recalling Evita Infinity V500 and Babylog Infinity VN500 ventilators because the optional PS500 power supply unit batteries may discharge prematurely despite showing adequate charge.
Product
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0935-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 189 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0800-2016·2016-03-02
Cook Inc. Recalls Single Lumen Pressure Monitoring Sets Due to Tip Fracture
Cook Inc. is recalling 2,280 single-lumen pressure monitoring sets and trays because a manufacturing defect may cause catheter tips to fracture or separate.
Product
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0802-2016·2016-03-02
Cook Inc. Recalls Radial Artery Pressure Monitoring Catheter Sets
Cook Inc. is recalling radial artery pressure monitoring catheter sets because a manufacturing defect may cause the catheter tip to fracture or separate.
Product
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0975-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0992-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 126 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0981-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0801-2016·2016-03-02
Cook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk
Cook Inc. is recalling specific femoral artery pressure monitoring catheter sets and trays because a manufacturing defect may cause the catheter tip to fracture or separate.
Product
Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0930-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 34 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents when disconnected.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0804-2016·2016-03-02
Maquet Flow-i Anesthesia System Recalled for Electrical Control Issues
Maquet is recalling seven Flow-i Anesthesia Systems in the US due to electrical issues in control and monitoring sub-systems that can cause restarts or system disabling.
Product
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0866-2016·2016-03-02
GSI Group Recalls PRN 50-M+ Paper Chart Recorders for Fire Risk
GSI Group Inc. is recalling 2,257 PRN 50-M+ Paper Chart Recorders due to a risk of fire or electrical shock.
Product
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner.…
Category
Medical Device
Distribution
Distributed nationwide

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22051–22075 of 27663