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

33551–33575 of 40325

ModerateFDA (Devices)·Z-1114-2015·2015-02-18
Arthrosurface Shoulder Prosthesis Components Recalled for Lack of US Clearance
Arthrosurface, Inc. is recalling 187 units of the HHXL (OVO) 15.6x32mm Taper Post Fixation Component because the product was not cleared for marketing in the US with its current indications.
Product
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1115-2015·2015-02-18
Zimmer Dental Recalls GemLock Long Hex Driver Due to Fit Issues
Zimmer Dental Inc is recalling 627 GemLock Long Hex Drivers because they may not fit into the Fixture Mount Transfer or the implant's internal hex.
Product
GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1067-2015·2015-02-18
Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error
Natus Medical is recalling EPWorks software versions prior to 6.0 because a software error prevents remote users from stopping free run waveform groups.
Product
EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1080-2015·2015-02-18
Arrow Epidural Needle Component Recalled for Missing Shelf Life Labeling
Arrow International Inc. is recalling 63,022 units of ARROW Epidural Needle Components because the product labeling does not specify the 5-year shelf life.
Product
ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1094-2015·2015-02-18
Synthes Recalls Hemostatic Bone Putty Due to Incorrect Brochure Revision
Synthes, Inc. is recalling 38 units of Hemostatic Bone Putty because Revision A of the brochure was distributed instead of the corrected Revision B.
Product
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-1076-2015·2015-02-18
MAST Biosurgery Recalls SurgiWrap Film Due to Expiration Date Mismatch
MAST Biosurgery is recalling 49 units of SurgiWrap Bioresorbable Adhesion Barrier Film because the expiration date on the barcode did not match the printed date.
Product
The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1081-2015·2015-02-18
Lacrimedics Recalls VisiPlugST Devices Due to Moisture-Related Breakage
Lacrimedics Inc is recalling VisiPlugST devices because moisture levels may cause the plugs to break apart or crumble upon contact.
Product
VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm.…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1077-2015·2015-02-18
Stryker Flyte Toga Recall Due to Incorrect Expiration Date Labeling
Stryker is recalling Flyte Togas with an incorrect expiration date. The label reads 2412-12-01 instead of 2014-12-01.
Product
Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1059-2015·2015-02-11
Siemens LINAC Accelerators Recalled for Overheating and Smoke Emission
Siemens Medical Solutions is recalling 310 LINAC Accelerators because the internal electric board may overheat, causing thermal damage and smoke emission.
Product
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1054-2015·2015-02-11
Cardinal Health Recalls Lubricated Intubating Stylets Due to Shear Risk
Cardinal Health is recalling 104,432 Lubricated Intubating Stylets 6FR because a small piece of the sheath may shear off during removal, posing a risk to infants and pediatric patients.
Product
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1017-2015·2015-02-11
FDA Recalls Covidien Trellis-6 Peripheral Infusion Systems Due to Labeling Error
The FDA is recalling 216 units of the Covidien Trellis-6 Peripheral Infusion System because a manufacturing error caused the balloon inflation ports to be incorrectly labeled.
Product
Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1034-2015·2015-02-11
Animas Vibe Insulin Pump Recalled Due to Calibration Factor Overwrite
Animas Corporation is recalling 1,235 Vibe Insulin Infusion Pumps because calibration factors were overwritten, potentially causing the pump to fail to detect cartridges or alarms.
Product
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1018-2015·2015-02-11
FDA Recalls Covidien Trellis-8 Peripheral Infusion Systems Due to Labeling Error
FDA is recalling 1,032 units of the Covidien Trellis-8 Peripheral Infusion System because a manufacturing error caused the proximal and distal balloon inflation ports to be incorrectly labeled.
Product
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2015·2015-02-11
Invacare Recalls G-Series Bed Rails Due to Entrapment Safety Defect
Invacare is recalling G-Series bed rails because the mounting bracket does not meet entrapment safety specifications.
Product
G- Series Beds; G29 full length bed rails assembly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1042-2015·2015-02-11
Zimmer Persona Tibial Inserter Recalled for Potential Tip Fracture
Zimmer, Inc. is recalling 1,091 Persona Tibial Articular Surface Inserters due to a potential fracture of the instrument tip, which could cause tissue damage or require revision surgery.
Product
Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1038-2015·2015-02-11
SCC Soft Computer Recalls SoftLab Laboratory Information System Versions
SCC Soft Computer is recalling SoftLab versions 4.0.7.0 and 4.0.7.1 because the software fails to send abnormal flags for Reference Lab test results.
Product
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1049-2015·2015-02-11
Carl Zeiss Meditec FORUM Archive and Viewer Software Recall
Carl Zeiss Meditec is recalling FORUM Archive and Viewer software versions 3.1 and 3.2 due to a defect that may lead to misinterpretation of optical coherence tomography data.
Product
FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1060-2015·2015-02-11
Shape Medical Systems Recalls Cardiopulmonary Testing System Patient Interfaces
Shape Medical Systems is recalling 564 disposable patient interfaces for the Shape-HF Cardiopulmonary Testing System because they may produce erroneous results, potentially leading to incorrect diagnosis and treatment.
Product
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1039-2015·2015-02-11
Baxter Integrated APD Set Recalled for Leakage Complaints
Baxter Healthcare is recalling 8,640 units of Integrated APD Sets with Cassette 3-Prong due to leakage complaints. The sterile fluid path is used for peritoneal dialysis.
Product
Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1040-2015·2015-02-11
Sedecal MobileDiagnost wDR X-ray systems recalled for unexpected movement
Sedecal S.A. is recalling 283 MobileDiagnost wDR motorized portable diagnostic X-ray systems due to reports of unexpected movement.
Product
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1046-2015·2015-02-11
Radiometer ABL90 FLEX Analyzer Recall for Calibration Data Errors
Radiometer America Inc. is recalling ABL90 FLEX analyzers because they may not use the most recent calibration data, potentially leading to biased patient results.
Product
ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1055-2015·2015-02-11
BD 10 mL Syringes Recalled Due to Improperly Seated Stopper
Becton Dickinson is recalling 564,000 units of 10 mL syringes because the stopper is not properly seated in the syringe.
Product
BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1052-2015·2015-02-11
Zimmer Recalls Persona Tibial Articular Surface Provisional Shims Due to Cleaning Defect
Zimmer, Inc. is recalling Persona Tibial Articular Surface Provisional Shims because repeated sonic cleaning can break the ball bearing retention feature, potentially leaving parts in the surgical wound.
Product
Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1041-2015·2015-02-11
Roche Cobas b 221 Blood Gas Analyzer Recalled for Measurement Bias
Roche Diagnostics is recalling 103 Cobas b 221 analyzers because bacterial contamination causes inaccurate glucose and lactate readings.
Product
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1053-2015·2015-02-11
CareFusion Recalls SmartSite Infusion Sets Due to Disconnection and Leakage
CareFusion is recalling 7,440 SmartSite Low Sorbing Infusion Sets due to disconnection and leakage issues.
Product
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular…
Category
Medical Device
Distribution
Distributed nationwide

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