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

36401–36425 of 40449

ModerateFDA (Devices)·Z-1093-2014·2014-03-05
Dako HER2 CISH pharmDx Kit Recalled Due to Weak Red Signals
Dako North America Inc. is recalling 49 units of the HER2 CISH pharmDx Kit because weak red signals have been observed.
Product
Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1121-2014·2014-03-05
Medtronic Everest 20cc Inflation Device Recalled for Incorrect Master Label
Medtronic Vascular is recalling 191 Everest 20cc Inflation Devices due to an incorrect master label. The devices are sterile, single-use tools used to inflate balloon catheters.
Product
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0980-2014·2014-02-26
Merit Medical Recalls Custom Procedural Trays Contaminated with Particulate Matter
Merit Medical Systems is recalling custom procedural trays containing 1% Lidocaine HCl injection due to visible particulate matter found in the product container.
Product
Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0995-2014·2014-02-26
Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D Arterial Cannulae because the device body may split near the suture collar.
Product
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1059-2014·2014-02-26
Elekta Synergy XVI Radiation Therapy System Recalled for Table Position Error
Elekta is recalling Synergy XVI radiation therapy systems because a software error can cause the treatment table to move to an incorrect position during specific online registration procedures.
Product
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0999-2014·2014-02-26
Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.
Product
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1000-2014·2014-02-26
Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Splitting
Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.
Product
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0993-2014·2014-02-26
Standing Company Recalls Superstand Wheelchairs Due to Flex Shaft Fracture Risk
The Standing Company is recalling approximately 119 Superstand stand-up wheelchairs because the flex shaft may fracture if bent repeatedly or beyond 90 degrees.
Product
Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1062-2014·2014-02-26
Bausch & Lomb Recalls AKREOS AO Micro Incision Lenses Due to Material Error
Bausch & Lomb is recalling 336 AKREOS AO Micro Incision Lenses because they were manufactured with incorrect raw material. The lenses are intended for cataract surgery.
Product
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0982-2014·2014-02-26
GE Healthcare Recalls Dash Patient Monitors Due to Network and ECG Issues
GE Healthcare is recalling Dash 3000, 4000, and 5000 Patient Monitors and Dash Port 2 Docking Stations due to network communication failures and distorted ECG waveforms.
Product
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0998-2014·2014-02-26
Medtronic Recalls Select CAP Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select CAP Arterial Cannulae because the cannula body may split near the suture collar. The devices are used for short-term cardiopulmonary bypass.
Product
Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1061-2014·2014-02-26
Elekta Synergy XVI Radiation Therapy System Recalled for Collision Risk
Elekta, Inc. is recalling 312 Synergy XVI radiation therapy systems due to a potential collision risk when used with external beam shaping devices.
Product
Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2014·2014-02-26
B. Braun Recalls SAFSITE Injection Sites and IV Sets Due to Leakage
B. Braun Medical is recalling specific lots of SAFSITE Injection Sites and IV Sets because complaints reported leakage. The devices are used for needle-free access on IV and extension sets.
Product
SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2014·2014-02-26
GE Healthcare Recalls PET Discovery Systems Due to Scatter Overcorrection
GE Healthcare is recalling PET Discovery 600, 610, 690, and 710 systems due to a potential safety issue with the List Mode Replay feature causing scatter overcorrection.
Product
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy…
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-1030-2014·2014-02-26
Zimmer Recalls ZIMTRON 6 DEG 22 Heads Due to Packaging Validation Issues
Zimmer, Inc. is recalling ZIMTRON 6 DEG 22 Heads because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Product
ZIMTRON 6 DEG 22 HEADS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1045-2014·2014-02-26
Biosense Webster Recalls CartoUnivu Module for Map Misalignment
Biosense Webster is recalling the CartoUnivu Module for the Carto 3 System due to potential misalignment between the map display and fluoroscopic images.
Product
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1026-2014·2014-02-26
Zimmer Recalls HGP II Acetabular Cup Due to Packaging Validation Issues
Zimmer is recalling HGP II Acetabular Cup Mod units because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
HGP II ACETABULAR CUP MOD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1057-2014·2014-02-26
Synthes Driving Cap/Threaded Recalled for Binding in Insertion Handles
Synthes, Inc. is recalling 143 units of the Driving Cap/Threaded because the parts can bind in insertion handles, making them difficult to separate.
Product
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0997-2014·2014-02-26
Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.
Product
Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2014·2014-02-26
Siemens Prisma 2K Pediatric Hearing Aid Battery Compartment Recall
Siemens is recalling Prisma 2K hearing aids because the battery compartment may open under unintended use, posing a risk to infants and children.
Product
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0996-2014·2014-02-26
Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.
Product
Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2014·2014-02-26
Integra CUSA Excel CEM Nosecone Recalled for Sticking Button
Integra LifeSciences is recalling CUSA Excel CEM nosecones because the blue COAG button may stick in the activated position.
Product
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0990-2014·2014-02-26
Perrigo Recalls Orbit Soft Infusion Sets Due to Connector Incompatibility
Perrigo Diabetes Care is recalling Orbit soft Infusion sets because the luer-lock connectors are incompatible with standard infusion pumps.
Product
Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1044-2014·2014-02-26
Zimmer Recalls Self-Tapping Cortical Screws Due to Packaging Validation Issues
Zimmer is recalling 7 million self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1005-2014·2014-02-26
Zimmer Recalls Versa-FX II Knee Implants Due to Packaging Validation Issues
Zimmer is recalling Versa-FX II knee implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941
Category
Medical Device
Distribution
Distributed nationwide

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36401–36425 of 40449