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

26601–26625 of 40233

ModerateFDA (Devices)·Z-2319-2017·2017-06-14
Nexstim eXima NBS System Software Recalled for File Duplication Defect
Nexstim PLC is recalling 11 units of the eXima NBS System due to a software defect that may generate duplicate files.
Product
Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2310-2017·2017-06-14
Cook Medical Recalls Willscher Vas Reapproximator Sets Due to Reprocessing Instructions
Cook Medical is voluntarily recalling Willscher Vas Reapproximator Sets because the reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.
Product
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2220-2017·2017-06-14
Iba Dosimetry Recalls Large Stealth Chamber Dosimeters for Measurement Deviations
Iba Dosimetry is recalling 110 Large Stealth Chambers because they may show measurement deviations and geometric shadowing when used as reference detectors.
Product
Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2311-2017·2017-06-14
Cook Medical Recalls Willscher Vas Skewers Due to Insufficient Reprocessing Instructions
Cook Medical is voluntarily recalling Willscher Vas Skewers because the provided instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.
Product
Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2251-2017·2017-06-14
Teleflex Recalls Pediatric Nasal Cannulas Due to Incorrect Labeling
Teleflex Medical is recalling 1,150 Hudson RCI Pediatric Nasal Cannulas because the box label says 'Pediatric' while the insert says 'Adult'.
Product
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-2320-2017·2017-06-14
Nexstim Navigated Brain Stimulation System Software Defect Recall
Nexstim PLC is recalling 21 units of the Navigated Brain Stimulation System due to a software defect that may generate duplicate files.
Product
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2315-2017·2017-06-14
Cook Medical Recalls LapSac Introducer Sets Due to Insufficient Reprocessing Instructions
Cook Medical is voluntarily recalling 335 LapSac Introducer Sets because the provided reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.
Product
LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2312-2017·2017-06-14
Cook Medical Recalls Willscher Vas Reapproximator Plates Due to Reprocessing Instructions
Cook Medical is voluntarily recalling Willscher Vas Reapproximator Plates because the reprocessing instructions lack sufficient detail for cleaning, disinfection, and sterilization.
Product
Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2309-2017·2017-06-14
Beekley Medical Mammography Skin Markers Recalled for Mislabeling
Beekley Corporation is recalling 0-SPOT Mammography Skin Markers because they were mislabeled with A-SPOT labels. The recall affects 6,032 units distributed in the US and Canada.
Product
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-2252-2017·2017-06-14
Argon Medical Recalls Arterial Access Needles Due to Packaging Defect
Argon Medical Devices is recalling specific arterial access needles due to a potential packaging defect involving unsealed pouches.
Product
Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2316-2017·2017-06-14
MedTest DX Assayed Human Multi Sera Control Recall for Out-of-Spec Values
Medtest Holdings, Inc. is recalling MedTest DX Assayed Human Multi Sera Control Level 1 and Level 2 because control values are outside of specification.
Product
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2221-2017·2017-06-14
Acumedia Urea Base Agar Recalled for Incorrect Storage Labeling
Acumedia is recalling Urea Base Agar because the label listed an incorrect storage temperature range.
Product
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-2151-2017·2017-06-07
Abbott Absorb Bioresorbable Vascular Scaffold Recalled for Elevated Adverse Event Rates
Abbott Vascular is recalling the Absorb Bioresorbable Vascular Scaffold (BVS) System in Australia due to studies showing higher rates of major adverse events, including myocardial infarction and scaffold thrombosis, compared to metallic stents.
Product
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2175-2017·2017-06-07
Philips NMT Patient Cable Recall for Potential Skin Burn Risk
Philips is recalling NMT Patient Cables used with IntelliVue NMT Modules because a manufacturing defect may cause localized heating and skin burns.
Product
NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-2211-2017·2017-06-07
Madison Polymeric Engineering Recalls Contaminated Draco Enzymatic Deep-Cleaning Pads
Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to contamination with Cladosporium cladosporioides/herbarum/phaenocomae.
Product
Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2179-2017·2017-06-07
GE Healthcare Recalls Patient Steps on RFX, Legacy, and Precision 500D Systems
GE Healthcare is recalling 2,380 patient steps for RFX, Legacy, and Precision 500D systems because they may detach from the table, posing a fall risk.
Product
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2180-2017·2017-06-07
Vascular Solutions Recalls Dolphin Inflation Devices Due to Sterile Barrier Defect
Vascular Solutions, Inc. is recalling 4,110 Dolphin Inflation Devices due to a potential sterile barrier defect that could lead to microbial contamination and infection.
Product
Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two…
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2176-2017·2017-06-07
AbbVie Recalls 673 PEG Kits Due to Sterility Concerns
AbbVie Inc. is voluntarily recalling 673 PEG kits because they may not be sterile. The recall covers lots distributed nationwide and internationally.
Product
AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2217-2017·2017-06-07
Cardinal Digital Bariatric Scales Recalled Due to Seat Failure Risk
Cardinal Scale Mfg Co is recalling 975 digital bariatric scales because a seat may fail unexpectedly, posing an injury risk.
Product
Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2198-2017·2017-06-07
Zimmer Biomet Recalls Reusable Orthopedic Instruments Due to Durability Concerns
Zimmer Biomet is recalling reusable instruments for knee, hip, trauma, and extremities because their durability characteristics were not established.
Product
Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2171-2017·2017-06-07
KCI USA Recalls 1000 ml Canisters for Negative Pressure Wound Therapy Systems
KCI USA is recalling 5,385 cases of 1000 ml canisters for InfoV.A.C. and V.A.C.ULTA systems due to a potential sterile barrier breach.
Product
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2152-2017·2017-06-07
Hans Pausch Uroview FD Fluoroscopic X-ray System Recalled for Footswitch Safety Issue
Hans Pausch is recalling 10 Uroview FD fluoroscopic X-ray systems because the footswitch used to activate radiation is part of the safety circuit.
Product
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2174-2017·2017-06-07
Ethicon Endopath ETS-FLEX Endoscopic Linear Cutter Recalled for Gear Failure Risk
Ethicon Endo-Surgery Inc is recalling 792 units of the Endopath ETS-FLEX Endoscopic Articulating Linear Cutter due to a risk of pinion gear failure under extreme use cases.
Product
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2215-2017·2017-06-07
Zimmer Biomet Recalls AFFIXUS Hip Fracture Nail Due to Sizing Defect
Zimmer Biomet is recalling 33,500 AFFIXUS Hip Fracture Nail units worldwide because certain undersized specifications may prevent the nail from properly engaging with the targeting jig.
Product
AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2219-2017·2017-06-07
Exact Sciences Sample Mixer 2 Recalled for Door Damage Incidents
Exact Sciences is recalling 15 Sample Mixer 2 units in Wisconsin due to door damage incidents caused by the Sample Holder lid.
Product
Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests
Category
Medical Device
Distribution
1 state

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26601–26625 of 40233