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

32701–32725 of 40449

ModerateFDA (Devices)·Z-2052-2015·2015-07-15
3M Removes Crown Indication from Lava Ultimate Dental Blocks
3M is initiating a field correction to remove the crown indication from all Lava Ultimate products. The products remain indicated for onlays, inlays, and veneers.
Product
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2039-2015·2015-07-15
Stradis DND Pack Recalled Due to Medtronic Component Recall
Stradis Healthcare is recalling DND Packs containing Devon Light Gloves because the glove manufacturer, Medtronic, is recalling the component.
Product
DND Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2005-2015·2015-07-15
Stradis Breast Augmentation Kits Recalled Due to Component Recall
Stradis Healthcare is recalling breast augmentation kits because they contain Devon Light Gloves, which are being recalled by the manufacturer Medtronic.
Product
Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2035-2015·2015-07-15
Stradis Face Lift Pack Recalled Due to Component Defect
Stradis Healthcare is recalling Face Lift Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
Product
Face Lift Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2000-2015·2015-07-15
Stradis Healthcare Recalls Lipo/Buttocks Surgical Packs Due to Component Recall
Stradis Healthcare is recalling Lipo/Buttocks Packs because they contain a Devon Light Glove component that Medtronic is recalling.
Product
Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2011-2015·2015-07-15
Stradis Suction Pack Recalled Due to Component Recall by Medtronic
Stradis Healthcare is recalling Suction Packs containing Devon Light Gloves because the manufacturer, Medtronic, recalled the glove component.
Product
Suction Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2032-2015·2015-07-15
Stradis Cysto Pack Recalled Due to Component Recall by Medtronic
Stradis Healthcare is recalling Cysto Packs because they contain Devon Light Gloves, which are being recalled by the manufacturer Medtronic.
Product
Cysto Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1997-2015·2015-07-15
Stradis Healthcare Recalls Phleb Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling Phleb Packs and Laser Phleb Packs because they contain Devon Light Gloves that are subject to a separate manufacturer recall.
Product
Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1999-2015·2015-07-15
Stradis Healthcare Recalls Lipo Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling Lipo Packs, Expended Packs, and Trays because they contain Devon Light Gloves that Medtronic is recalling.
Product
Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2027-2015·2015-07-15
Stradis ENT Packs Recalled Due to Medtronic Glove Component Recall
Stradis Healthcare is recalling ENT Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
Product
ENT Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2026-2015·2015-07-15
Stradis Healthcare Recalls Knee Arthro Packs Due to Component Recall
Stradis Healthcare is recalling Knee Arthro Packs because they contain a Devon Light Glove component that Medtronic is recalling.
Product
Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2010-2015·2015-07-15
Stradis Plastic Packs Recalled Due to Medtronic Component Recall
Stradis Healthcare is recalling Plastic Packs containing Devon Light Gloves because the manufacturer, Medtronic, recalled the glove component.
Product
Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2040-2015·2015-07-15
Stradis Orthopedic Split Drape Pack Recalled Due to Component Issue
Stradis Healthcare is recalling Orthopedic Split Drape Packs because they contain a Devon Light Glove component recalled by Medtronic.
Product
Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2033-2015·2015-07-15
Stradis Healthcare Recalls Surgical Convenience Kits Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling surgical convenience kits because they contain Devon Light Gloves that are subject to a separate recall by Medtronic.
Product
Open Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1998-2015·2015-07-15
Stradis Standard Pack Recalled Due to Medtronic Component Recall
Stradis Healthcare is recalling Standard Packs containing Devon Light Gloves because the glove component was recalled by Medtronic.
Product
Standard Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2028-2015·2015-07-15
Stradis Hand Pack Recall Due to Medtronic Glove Component Issue
Stradis Healthcare is recalling Hand Packs containing Devon Light Gloves due to a manufacturer recall of the glove component by Medtronic.
Product
Hand Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2018-2015·2015-07-15
Stradis Face Neck Pack Recalled Due to Component Defect
Stradis Healthcare is recalling Face Neck Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
Product
Face Neck Pack - contains Devon Light Glove Used during surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2056-2015·2015-07-15
Integra Recalls Tuohy Needles Due to Incorrect Gauge and Length Labeling
Integra LifeSciences is voluntarily recalling 123 Tuohy needles because they were incorrectly labeled as 18 gauge, 3.5 inch instead of 20 gauge, 5 inch.
Product
Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2049-2015·2015-07-15
Bard Access Systems Recalls PowerPICC Solo Catheters for Labeling Errors
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because the primary labels display incorrect expiration dates.
Product
PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2048-2015·2015-07-15
Bard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because they have incorrect expiration dates on the primary labeling.
Product
PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2055-2015·2015-07-15
Volk Optical Recalls Lombart 90D Clear Lenses Due to Mislabeling
Volk Optical Inc is recalling 78 units of the Lombart 90D Clear lens due to an incorrect lot number engraved on the aluminum ring.
Product
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2050-2015·2015-07-15
Bard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because the primary labels contain incorrect expiration dates.
Product
PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2047-2015·2015-07-15
Bard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because the primary labels contain incorrect expiration dates.
Product
PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1902-2015·2015-07-08
FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues
The FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Product
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1917-2015·2015-07-08
HeartWare Ventricular Assist System Recalled for Power Switching Issues
HeartWare Inc. is recalling HVAD systems due to abnormal power source switching. The device is used as a bridge to cardiac transplantation.
Product
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Category
Medical Device
Distribution
32 states

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32701–32725 of 40449