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

39251–39275 of 40449

ModerateFDA (Devices)·Z-0503-2013·2012-12-19
ConMed Recalls WANG Transbronchial Aspiration Needles for Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope channel, causing minor inconvenience.
Product
WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed…
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0500-2013·2012-12-19
Voluntary Recall of Performa TENS Electrodes Due to Manufacturing Exposure
Covidien is voluntarily recalling specific lots of Performa TENS electrodes because wire surfaces may have been exposed to an employee with a minor cut during manufacturing.
Product
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0515-2013·2012-12-19
Siemens MAVIG PORTEGRA 2 Surgical Light Recall for Missing Component
Siemens is recalling 1,315 MAVIG PORTEGRA 2 surgical lights because a specific component may have been omitted during installation.
Product
MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0522-2013·2012-12-19
Roche Recalls Cobas b 123 Fluid Pack Cuvettes Due to Thickness Defect
Roche Diagnostics is recalling specific lots of Cobas b 123 Fluid Pack COOX cuvettes because a production error caused a change in layer thickness, leading to a higher failure rate.
Product
Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0509-2013·2012-12-19
Siemens ADVIA Centaur DHEAS Assay Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur DHEAS assays because room temperature changes can alter test results.
Product
Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0487-2013·2012-12-19
Roche LightCycler 1.2 Diagnostic Software Recalled for Device-Associated Issue
Roche Molecular Systems is recalling LightCycler 1.2 software due to a device-associated diagnostic software issue. The recall covers 3,772 units distributed nationwide.
Product
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0488-2013·2012-12-19
Roche Recalls LightCycler 2.0 Instrument Due to Diagnostic Software Issue
Roche Molecular Systems is recalling 1,213 LightCycler 2.0 instruments due to a device-associated diagnostic software issue.
Product
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0481-2013·2012-12-19
Hospira Recalls Plum A+ Infusion Pumps Due to Reversed Volume Knob
Hospira is recalling Plum A+ single channel infusion pumps because the volume control knob may function in reverse, causing alarm volume to increase when turned clockwise.
Product
Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0513-2013·2012-12-19
Mindray Recalls DPM 6 and 7 Patient Monitors for Software Limitations
Mindray DS USA is recalling 124 DPM 6 and 7 patient monitors because specific calculation features may be unavailable.
Product
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0517-2013·2012-12-19
Quasar Bio-Tech Recalls Unapproved Baby Quasar Infrared LED Lamps
Quasar Bio-Tech is recalling Baby Quasar and Baby Quasar Pink infrared LED lamps because the devices are unapproved by the FDA.
Product
Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0482-2013·2012-12-19
Hospira Plum A+ Infusion Pumps Recalled for Reversed Volume Control Knob
Hospira is recalling Plum A+ Hyperbaric Infusion Pumps because the volume control knob may function in reverse, causing alarm volume to increase when turned clockwise.
Product
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0504-2013·2012-12-19
ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.
Product
WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed…
Category
Medical Device
Distribution
14 states
SevereFDA (Devices)·Z-0467-2013·2012-12-12
iwalk BiOM Battery and Charger Recalled for Overheating and Smoke Risk
iwalk inc is recalling BiOM lower leg system batteries and chargers because they may overheat and smoke during charging.
Product
BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0447-2013·2012-12-12
Natus Olympic Cool-Cap Recalled Due to Frozen Screen Malfunction
Natus Medical is recalling 324 Olympic Cool-Cap systems because the control module screen may freeze, causing the device to stop cooling infants without visible alarm.
Product
The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0471-2013·2012-12-12
Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Risk
Biomet is recalling 46 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.
Product
OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0457-2013·2012-12-12
Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.
Product
24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0462-2013·2012-12-12
Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients during surgery.
Product
24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0458-2013·2012-12-12
Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip could detach and harm patients during surgery.
Product
24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0464-2013·2012-12-12
Merit Medical Systems Recalls Custom Procedural Trays Due to Missing Tape
Merit Medical Systems is recalling 83 custom procedural trays because clear protective tape was not applied during manufacturing.
Product
Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0475-2013·2012-12-12
Philips Digital Diagnost Software Recall for Image Marker Error
Philips is recalling Digital Diagnost Software R2.0.2 because a mirrored image marker can be mistaken for a patient side indicator.
Product
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0472-2013·2012-12-12
Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Defect
Biomet is recalling 36 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.
Product
OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0455-2013·2012-12-12
Stryker Neptune 2 Rover Recall Due to Binding Casters
Stryker is recalling 154 Neptune 2 Rover units because a castor design defect can cause binding, leading to operator strain and back pain.
Product
Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0474-2013·2012-12-12
Biomet Recalls Bio-Modular Humeral Heads Due to Missing Ion Implantation
Biomet, Inc. is recalling four Bio-Modular Humeral Heads because they are missing the ion implantation feature, which may cause increased wear and shorter implant life.
Product
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0452-2013·2012-12-12
Siemens IRON Flex Reagent Cartridges Recalled for Falsely Elevated Results
Siemens Healthcare Diagnostics is recalling IRON Flex reagent cartridges because environmental iron contamination can cause falsely elevated test results.
Product
Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of…
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-0466-2013·2012-12-12
Philips and Neusoft Recall CT Scanners Due to Detaching Patient Table
Philips and Neusoft are recalling 45 CT scanners because the patient table top can detach from the carrier, posing a risk of injury.
Product
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and…
Category
Medical Device
Distribution
Distributed nationwide

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39251–39275 of 40449