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

37451–37475 of 40449

ModerateFDA (Devices)·Z-2291-2013·2013-10-09
GE Healthcare Recalls MR Scanners Due to Exposed Foam on End Bells
GE Healthcare is recalling specific MRI scanners because yellow foam on the end bells may extend past the covers. The foam itself is not hazardous, but it may absorb fluids.
Product
GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial…
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-2313-2013·2013-10-09
Atrium Medical Recalls Advanta VXT Grafts Due to Label Adhesion Issue
Atrium Medical Corporation is recalling Advanta VXT Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2303-2013·2013-10-09
Radiometer Lactate Membrane Units Recalled for Enzyme Residue
Radiometer America Inc. is recalling Lactate Membrane units for the E7077 Electrode due to potential enzyme residue that may cause inaccurate test results.
Product
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0002-2014·2013-10-09
King Systems Recalls Mislabelled Oropharyngeal Airways Due to Size Error
King Systems Corp. is voluntarily recalling one case of King LTS-D Oropharyngeal Airways because the package label incorrectly identified the size.
Product
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2311-2013·2013-10-09
Atrium Medical Recalls Advanta SST Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta SST Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2314-2013·2013-10-09
Atrium Flixene Grafts Recalled Due to Difficult Tray Removal
Atrium Medical Corporation is recalling Flixene Trumpet Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2310-2013·2013-10-09
Atrium Flixene Grafts Recalled Due to Difficult-to-Remove Inner Tray Label
Atrium Medical Corporation is recalling Flixene Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2307-2013·2013-10-09
Atrium Flixene IFG Recall Due to Label Adhesion Issue
Atrium Medical Corporation is recalling Flixene IFG with Assisted Delivery because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2315-2013·2013-10-09
Atrium Medical Recalls Advanta VS Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta VS Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2308-2013·2013-10-09
Atrium Medical Recalls Advanta SST Bifurcated Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta SST Bifurcated Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2302-2013·2013-10-09
Medtronic NC Sprinter Balloon Catheter Recalled for Incorrect Size Labeling
Medtronic is recalling 122 units of NC Sprinter Balloon Dilatation Catheters because the compliance chart lists the size as 2.5mm instead of the correct 2.25mm.
Product
NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2319-2013·2013-10-09
DeVilbiss Disposable Suction Container Filter Recall Due to Fluid Exposure
DeVilbiss Healthcare LLC is recalling specific Disposable Suction Container/Filter units because fluid exposure can occlude the bacterial filter, rendering it unusable.
Product
DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2317-2013·2013-10-09
Atrium Medical Recalls Advanta SST Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta SST Grafts because the inner tray label may adhere to the outer tray, making removal difficult.
Product
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2316-2013·2013-10-09
Atrium Medical Recalls Advanta SST Grafts Due to Label Adhesion Issue
Atrium Medical Corporation is recalling Advanta SST Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2305-2013·2013-10-09
Atrium Flixene IFG Vascular Grafts Recalled for Label Adhesion Issue
Atrium Medical Corporation is recalling Flixene IFG Vascular Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2270-2013·2013-10-02
Invacare Power Wheelchair Recall for Unintended Slowing or Acceleration
Invacare is recalling power wheelchairs with specific joysticks due to unintended slowing or acceleration. Users should stop using the device and contact Invacare.
Product
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-2285-2013·2013-10-02
CareFusion Recalls SmartSite Infusion Sets Due to Tubing Separation Risk
CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the tubing sleeve may separate below the drip chamber.
Product
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2013·2013-10-02
Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Bond Strength Defects
Maquet Cardiovascular is recalling specific lots of QUADROX oxygenators used in cardiac surgery because they may not meet specifications for bond strength on connectors.
Product
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2271-2013·2013-10-02
Stryker Vision Mounting Arm Recalled Due to Display Detachment Risk
Stryker Endoscopy is recalling 14,271 Vision Mounting Arms because excessive force can cause the display to detach and fall on users or patients.
Product
Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The…
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2264-2013·2013-10-02
Endoplus 5mm Laparoscopic Grasper Recalled for Broken Jaw
Endoplus is recalling 81 units of 5mm Atraumatic Graspers because the moveable jaw broke during surgery. The devices were distributed in Florida, Texas, and Virginia.
Product
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2275-2013·2013-10-02
Maquet Recalls TEGRIS System Due to Missing Emergency Stop Button
Maquet is recalling 21 TEGRIS systems because a secondary touch screen display lacks an emergency stop button.
Product
TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2261-2013·2013-10-02
Terumo Pall AL6X Arterial Blood Line Filter Recall for Defective Device
Terumo is recalling 15,817 arterial blood line filters used in cardiovascular procedures because the devices are defective.
Product
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2013·2013-10-02
BD Recalls Epilor Syringes Due to Plunger Sticking Hazard
Becton Dickinson is recalling BD Epilor syringes because the plunger may stick, preventing users from detecting loss of resistance during epidural procedures.
Product
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-2282-2013·2013-10-02
Synthes Oracle Spacer System Slap Hammer Recalled for Breakage During Use
Synthes USA HQ, Inc. is recalling 27 units of the Oracle Spacer System Slap Hammer because the proximal end broke during use.
Product
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2263-2013·2013-10-02
Steris Reliance Endoscope Processing System Recalled for Air Pipe Defect
Steris is recalling 266 Reliance Endoscope Processing Systems because an air pipe defect prevents forced flow during the disinfection cycle.
Product
Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant…
Category
Medical Device
Distribution
Distributed nationwide

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37451–37475 of 40449