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

25976–26000 of 27722

HighFDA (Devices)·Z-2301-2013·2013-10-09
Hologic Selenia Mammography System Software Recall for Image Deletion
Hologic is recalling 62 Selenia Full Field Digital Mammography Systems because software versions 5.0.x and 5.1.x may delete recent images when the hard drive reaches a 4,000-image threshold.
Product
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital…
Category
Medical Device
Distribution
19 states
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
HighFDA (Devices)·Z-2277-2013·2013-10-02
Elekta Recalls Monaco RTP System Radiation Therapy Treatment Planning System
Elekta, Inc. is recalling 72 units of the Monaco RTP System Radiation Therapy Treatment Planning System because patients must be positioned as indicated by the treatment plan.
Product
Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-2265-2013·2013-10-02
Endoplus 5 mm Traumatic Grasper Recalled for Broken Jaw
Endoplus is recalling 9 units of 5 mm Traumatic Graspers because the moveable jaw broke during laparoscopic procedures.
Product
ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic 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-2284-2013·2013-10-02
Medtronic Xomed Recalls Universal Titanium Ear Prosthesis Due to Assembly Error
Medtronic Xomed is recalling 60 units of Universal Titanium Prosthesis because one lot was assembled with the wrong component.
Product
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2188-2013·2013-09-25
B. Braun Outlook ES Infusion Pumps Recalled for Display Error
B. Braun Medical Inc. is recalling Outlook ES pumps because the display may show infusion is active when the pump has actually stopped.
Product
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2227-2013·2013-09-25
Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.
Product
OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2223-2013·2013-09-25
Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling OSTEORAPTOR 2.3 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Product
OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2226-2013·2013-09-25
Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Product
OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2241-2013·2013-09-25
GE Healthcare recalls READY View fMRI software due to incorrect maps
GE Healthcare is recalling READY View software because it may compute and display incorrect fMRI activation maps.
Product
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2200-2013·2013-09-25
Medtronic Recalls T8 Removal Heads Due to Incorrect Hardness Specification
Medtronic is recalling nine T8 Removal Heads used in spinal surgery due to incorrect hardness specifications that could cause the tool to fail during implant removal.
Product
T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2256-2013·2013-09-25
GE Healthcare Recalls CARESCAPE Monitor B650 Due to Potential Issues
GE Healthcare is recalling CARESCAPE Monitor B650 units due to potential issues. No injuries or illnesses have been reported.
Product
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2224-2013·2013-09-25
Smith & Nephew Recalls OSTOSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling OSTOSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Product
OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2244-2013·2013-09-25
Instrumentation Laboratory Recalls ACL TOP Analyzers Due to Carryover Issue
Instrumentation Laboratory is recalling 929 ACL TOP analyzers because a potential carryover issue may cause shortened APTT clotting times.
Product
ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems…
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2251-2013·2013-09-25
Churchill Medical Recalls Vygon 14 Microbore Extension Sets
Churchill Medical Systems is recalling 13,100 Vygon 14 Microbore Extension Sets because the tubing may disconnect from the male luers.
Product
Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2160-2013·2013-09-25
Villa Radiology Juno DRF Mobile X-ray System Recalled for Display Errors
Villa Radiology Systems LLC is recalling 22 Juno DRF mobile X-ray systems because displayed radiation dose values may be inaccurate by more than 35%.
Product
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Category
Medical Device
Distribution
16 states

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25976–26000 of 27722