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

29076–29100 of 40325

HighFDA (Devices)·Z-2725-2016·2016-09-14
Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm
Hospira is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.
Product
Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2769-2016·2016-09-14
Innovision Innocor Cardiopulmonary Testing System Recalled for Electric Shock Risk
Innovision A/S is recalling eight Innocor Cardiopulmonary Exercise and Lung Function Testing Systems to replace USB cables that lack galvanic isolation, preventing potential electric shock.
Product
Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2765-2016·2016-09-14
Hologic Recalls SureSight Obturator Introducer Systems Due to Tip Breakage
Hologic is recalling 1,440 SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.
Product
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2737-2016·2016-09-14
Philips BrightView XCT Upgrade Recalled for Potential Patient Contact
Philips is recalling three BrightView XCT Upgrade units due to a software defect that may cause the detector to contact patients during specific scans.
Product
BrightView XCT Upgrade Model 882454
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2729-2016·2016-09-14
Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm
Hospira Inc. is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.
Product
Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2734-2016·2016-09-14
Omega Medical Imaging Recalls Elevating Monitor Suspension Systems
Omega Medical Imaging is recalling 26 Elevating Monitor Suspension Systems because the suspension may separate from the lifting column bracket.
Product
2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2738-2016·2016-09-14
Terumo Recalls Pinnacle Introducer Sheaths Due to Valve Leakage
Terumo Medical Corporation is recalling Pinnacle Introducer Sheaths due to a manufacturing issue causing valve leakage, which poses a risk of incremental blood loss.
Product
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2762-2016·2016-09-14
Riverpoint Medical Recalls Webglo Polypropylene Surgical Sutures Due to Seal Issues
Riverpoint Medical is recalling specific lots of Webglo polypropylene surgical sutures because the seals may open during distribution or packaging.
Product
Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2763-2016·2016-09-14
Blackrock NeuroPort Biopotential Signal Processing System Recall for Labeling Error
Blackrock Microsystems is recalling 81 Neural Signal Amplifiers because the device and patient cable are incorrectly labeled as Type CF Applied Parts.
Product
Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2764-2016·2016-09-14
Blackrock NeuroPort Patient Cables Recalled for Incorrect Labeling
Blackrock Microsystems is voluntarily recalling 120 Patient Cables because they are incorrectly labeled as Type CF Applied Parts.
Product
Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2742-2016·2016-09-14
Siemens ADVIA Centaur PSA Assay Recall for Clinical Interpretation Clarification
Siemens Healthcare Diagnostics is recalling ADVIA Centaur PSA Assay kits to emphasize that PSA values must be interpreted according to current clinical guidelines for biochemical recurrence.
Product
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2756-2016·2016-09-14
Sorin Aortic Arch Cannula Recalled for Improper Tip Angle
Sorin Group USA is recalling Aortic Arch Cannulas because the tip angle is less than the required 45 or 90 degrees.
Product
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2747-2016·2016-09-14
Mentor Breast Tissue Expanders Recalled Due to Product Mix-Up
Mentor Texas, LP. is recalling 65 units of MENTOR CPX4 breast tissue expanders because a 350cc unit was found in a carton intended for 450cc units.
Product
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2743-2016·2016-09-14
Integra Recalls Achillon Suture System Due to Sterility Concerns
Integra LifeSciences is recalling the Achillon Suture System because internal studies suggest the secondary package seal may not maintain intended sterility.
Product
Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2748-2016·2016-09-14
Mentor CPX4 Breast Tissue Expanders Recalled for Product Mix-Up
Mentor Texas, LP. is recalling 70 units of CPX4 breast tissue expanders because a 350cc product was found in a carton labeled for the 450cc version.
Product
MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2744-2016·2016-09-14
Ecolab Recalls Microtek Angiography Drapes Due to Packaging Defects
Ecolab is recalling specific Microtek angiography drapes because their sterile packaging may contain small holes in the film, potentially compromising sterility.
Product
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2752-2016·2016-09-14
Zimmer Biomet Recalls Coonrad/Morrey Elbow Replacement Kits Due to Missing Parts
Zimmer Biomet is recalling a specific lot of Coonrad/Morrey Elbow Pin/Bushing Replacement Kits because they are missing a humeral bushing, which could delay surgery.
Product
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the…
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-2767-2016·2016-09-14
Novadaq Recalls SK6000 PAQ Sterile Drape Pouches Due to Pinhole Defect
Novadaq is recalling 20 units of SK6000 PAQ sterile drape pouches because pinholes were found in the film material during shipping validation testing.
Product
Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2755-2016·2016-09-14
Aspen Surgical Recalls Misidentified Stainless Steel Surgical Blades
Aspen Surgical Puerto Rico Corp. is recalling 6,000 stainless steel surgical blades that were incorrectly labeled as size 12 instead of 12B.
Product
Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2754-2016·2016-09-14
Anthogyr Recalls Axiom 2.8 Dental Implants Due to Design Validation Failure
Anthogyr is recalling 10 units of Axiom 2.8 dental implants because an FDA inspection revealed the firm failed to validate the design and process of the devices.
Product
Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2753-2016·2016-09-14
Anthogyr Axiom REG Dental Implants Recalled for Design Validation Failure
Anthogyr is recalling 111 units of Axiom REG dental implants because an FDA inspection found the firm failed to validate the design and process of the devices.
Product
Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2759-2016·2016-09-14
Teleflex Horizon Manual-Load Ligating Clip Applier Recalled for Incorrect Etching
Teleflex Medical is recalling 49 units of Horizon Manual-Load Ligating Clip Appliers due to incorrect etching on the device.
Product
WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2720-2016·2016-09-14
ReliaMed Alginate Dressings Recalled for Misplaced Instructions
Advanced Medical Solutions is recalling ReliaMed Alginate/CMC dressings because instructions for use were misplaced in the packaging.
Product
ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2757-2016·2016-09-14
Sorin Coronary Artery Perfusion Cannula Recalled for Tip Angle Defect
Sorin Group USA is recalling 1,205 units of Coronary Artery Perfusion Cannulas with Balloons because the tip angle is less than the required 45 or 90 degrees.
Product
Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2739-2016·2016-09-14
GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk
GE Healthcare is recalling Centricity Enterprise Archive software version 3.0.x due to a potential for data loss when the cache disk is nearly full.
Product
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

29076–29100 of 40325