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

22026–22050 of 27663

HighFDA (Devices)·Z-1113-2016·2016-03-23
Zimmer Astel Femoral Head Recall Due to Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling sterile Astel femoral heads for hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: For use in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1162-2016·2016-03-23
Zimmer Manufacturing Recalls Unipolar Endo Femoral Heads Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling specific unipolar endo femoral heads used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi hip arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1063-2016·2016-03-16
Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation
Arrow International is recalling Percutaneous Insertion Trays because the sheath body may separate from the hub, creating a potential for bleeding.
Product
Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1058-2016·2016-03-16
Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding Risk
Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1059-2016·2016-03-16
Arrow UltraFlex IAB Recall: Sheath Separation Risk
Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1061-2016·2016-03-16
Arrow RediGuard IAB Recall Due to Sheath Separation Risk
Arrow International is recalling RediGuard IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1057-2016·2016-03-16
Arrow FiberOptix Ultra 8 IAB recalled for potential sheath separation
Arrow International is recalling FiberOptix Ultra 8 IAB devices because the sheath body may separate from the hub, posing a risk of bleeding.
Product
FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1081-2016·2016-03-16
Stryker Position Pro Mattress Recalled for Power Cord Fire Risk
Stryker is recalling Position Pro Mattresses because the power cord may melt, posing risks of electric shock and fire.
Product
Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1056-2016·2016-03-16
Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding
Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1055-2016·2016-03-16
Arrow FiberOptix Ultra 8 IAB Recalled for Potential Sheath Separation
Arrow International is recalling FiberOptix Ultra 8 IAB devices because the sheath body may separate from the hub, creating a risk of bleeding.
Product
FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1035-2016·2016-03-16
Verathon Recalls GlideScope Titanium Video Laryngoscope Blades Due to Image Flickering
Verathon is recalling GlideScope Titanium single-use video laryngoscope blades because the video image may flicker or distort during use.
Product
GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1060-2016·2016-03-16
Arrow UltraFlex IAB Recall for Potential Sheath Separation and Bleeding Risk
Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0911-2016·2016-03-16
Abbott Vascular Recalls MitraClip Clip Delivery System Due to Mandrel Fracture
Abbott Vascular is recalling the MitraClip Clip Delivery System because a mandrel fracture may prevent the clip from detaching during implantation.
Product
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1062-2016·2016-03-16
Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation
Arrow International is recalling specific Percutaneous Insertion Trays because the sheath body may separate from the hub, posing a risk of bleeding.
Product
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1047-2016·2016-03-16
Gi Supply Recalls Large Volume Paracentesis Kits Due to Missing Clamp
Gi Supply is recalling Large Volume Paracentesis Kits because the pinch clamp on the RP Bag may be missing, posing a splash hazard to users.
Product
Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1076-2016·2016-03-16
BD Intelliport Medication Management System Sensor Recalled for Sterility Concerns
Becton Dickinson is recalling 250 units of the BD Intelliport Medication Management System Sensor because the sterility of the product cannot be assured, posing an increased risk of infection.
Product
BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1068-2016·2016-03-16
Bard Denali Filter Delivery System Recalled for Cracking Stop Cocks
Bard Peripheral Vascular is recalling Denali Filter Delivery Systems because stop cocks may crack.
Product
Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1065-2016·2016-03-16
Philips Respironics Recalls Trilogy and Garbin Ventilators Due to Software Issue
Philips Respironics is recalling approximately 104,508 Trilogy and Garbin ventilators due to a software issue. The recall covers units distributed nationwide and internationally.
Product
Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1084-2016·2016-03-16
Sedecal Mobile X-ray Systems Recalled for Uncommanded Movements
Sedecal S.A. is recalling 349 mobile X-ray systems because static electricity and other issues can cause uncommanded movements.
Product
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1064-2016·2016-03-16
Arrow Recalls Percutaneous Sheath Introducer Sets Due to Packaging Damage
Arrow International Inc. is recalling Super Arrow-Flex Percutaneous Sheath Introducer Sets because packaging damage may compromise sterility, posing a potential infection risk.
Product
Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: ***…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1069-2016·2016-03-16
Bard Denali Filter Delivery Systems Recalled for Cracking Stop Cocks
Bard Peripheral Vascular is recalling Denali Filter Delivery Systems because stop cocks may crack.
Product
Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1082-2016·2016-03-16
Biomet Recalls Crosslock DVR ePAK Surgical Sets Due to Oxidation Risk
Biomet is recalling 21,268 Crosslock DVR ePAK surgical sets because components may oxidize during storage. This could cause an inflammatory reaction if material enters the surgical wound.
Product
Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1092-2016·2016-03-16
Spacelabs Xhibit Central Station Recalled for Height and Weight Input Error
Spacelabs Healthcare is recalling Xhibit Central Station units because patient height and weight values may be switched, causing incorrect Body Surface Area calculations.
Product
Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-1080-2016·2016-03-16
FDA Recalls Custom Tubing Extensions Due to Potential Cracking
Value Plastics is recalling 33,000 custom tubing extensions because the parts may crack. The devices were distributed to three consignees in New York, Pennsylvania, and Minnesota.
Product
Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1024-2016·2016-03-09
Philips SENSE Body Coil 1.5T Recalled for Potential Patient Burns
Philips is recalling 5,672 SENSE Body Coil 1.5T units because improper cable placement can cause patient burns during MRI scans.
Product
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Category
Medical Device
Distribution
Distributed nationwide

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22026–22050 of 27663