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

17601–17625 of 27534

HighFDA (Devices)·Z-2413-2018·2018-07-18
Medtronic Percepta CRT-P MRI SureScan Devices Recalled for Potential Reset
Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a timing interaction that may cause a device reset.
Product
Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2390-2018·2018-07-18
Roche Vitamin D Test System Recalled for Falsely Elevated Results
Roche Diagnostics is recalling the Elecsys Vitamin D total II test system because it may produce falsely elevated and non-reproducible results, potentially leading to incorrect vitamin D dosage adjustments.
Product
Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2412-2018·2018-07-18
Medtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk
Medtronic is recalling 1,842 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.
Product
Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2402-2018·2018-07-18
Stryker Recalls Femoral Nails Due to Potential Premature Breakage
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.
Product
Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2396-2018·2018-07-18
Stryker Recalls Nine Femoral Nails Due to Potential Premature Breakage
Stryker GmbH is recalling nine femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.
Product
Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2429-2018·2018-07-18
bioMerieux Recalls VIDAS Analyzers and Quality Control Tests for Performance Issues
bioMerieux is recalling VIDAS analyzers and Quality Control VIDAS tests due to pump clogging and label displacement that may cause erroneous assay results.
Product
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2424-2018·2018-07-18
Proteus 235 Proton Beam Device Recalled for Correction Vector Loss
Ion Beam Applications S.A. is recalling three Proteus 235 units because a software defect may cause patients to be treated in the wrong position.
Product
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2392-2018·2018-07-18
Steris Reliance 1227 Washer/Disinfector Recalled for Chemical Alarm Failure
Steris is recalling Reliance 1227 Washer/Disinfector units because the low chemical level alarm does not operate as intended, potentially preventing proper cleaning of patient care items.
Product
Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2426-2018·2018-07-18
Stryker Recalls Reprocessed Coronary Sinus Diagnostic Catheters
Stryker Sustainability Solutions is recalling 2,722 reprocessed Coronary Sinus Diagnostic EP Catheters because thrombogenicity tests showed they did not meet non-thrombogenic specifications.
Product
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2411-2018·2018-07-18
Fort Defiance P2131 Steam Sterilizer Recalled for Plumbing Deposits
Fort Defiance Industries is recalling 199 P2131 Automated Field Steam Sterilizers because stagnant water and metal interactions can create deposits that interfere with the rear sight gauge or water liquid level switch.
Product
FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2422-2018·2018-07-18
Cayenne Medical Recalls AperFix AM Femoral Implants Due to Breakage Risk
Cayenne Medical Inc. is recalling 976 units of AperFix AM Femoral Implants because they may break inside the femoral socket during orthopedic use.
Product
AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2416-2018·2018-07-18
Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy
Medtronic is recalling 103 EnTrust Dual Chamber ICDs because they may lose high voltage and anti-tachycardia pacing therapy near end-of-life without prior warning.
Product
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2391-2018·2018-07-18
Ekla Recalls NOVAPLUS Pregnancy Test Kits Due to Incorrect Results
Ekla Corporation is recalling 295 NOVAPLUS Pregnancy Cassette Devices because they may provide incorrect hCG results. The affected kits were distributed in California, Illinois, Minnesota, and Rhode Island.
Product
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2414-2018·2018-07-18
Medtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk
Medtronic is recalling 1,604 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.
Product
Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2427-2018·2018-07-18
FDA Recalls LigaSure Exact Dissector Nano Coated Due to Sterile Breach
FDA is recalling 936 units of LigaSure Exact Dissector Nano Coated instruments because sterile pouches were found with punctures.
Product
LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2347-2018·2018-07-11
FHC Depth Stop Adapter Recalled for Potential Lead Damage
FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter may damage implanted leads if over-tightened, potentially requiring replacement.
Product
microTargeting" Drive System, Product Number 66-ZD-MD
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-2346-2018·2018-07-11
FHC Depth Stop Adapter Recalled for Lead and Stylet Damage
FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage implanted leads and stylets when over-tightened, requiring device replacement.
Product
microTargeting" Drive System, Product Number MT-DS-01
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-2349-2018·2018-07-11
FHC Depth Stop Adapter Recalled for Potential Lead Damage
FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter may damage the lead and stylet if the screw is over-tightened.
Product
microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-2348-2018·2018-07-11
FHC Depth Stop Adapter Recalled for Lead and Stylet Damage
FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage leads and stylets, potentially causing short circuits.
Product
microTargeting" Drive System, Product Number 66-ZD-MD-01
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-2352-2018·2018-07-11
FHC Depth Stop Adapter Recalled for Potential Lead Damage
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, causing short circuits and requiring replacement.
Product
microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-2350-2018·2018-07-11
FHC Depth Stop Adapter Recall Due to Lead and Stylet Damage
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads and stylets, requiring replacement.
Product
microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-2359-2018·2018-07-11
FHC Depth Stop Adapter Recalled for Lead Damage Risk
FHC, Inc. is recalling Depth Stop Adapters because over-tightening the screw can damage implanted leads, requiring removal and replacement.
Product
microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-2356-2018·2018-07-11
FHC Depth Stop Adapter Recalled for Potential Lead and Stylet Damage
FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.
Product
microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-2345-2018·2018-07-11
FHC microTargeting Drive System Recalled for Lead Damage Risk
FHC, Inc. is recalling 2,952 microTargeting Drive Systems because over-tightening the depth stop screw can damage implanted leads, requiring replacement.
Product
microTargeting" Drive System, Product Number MT-DS
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-2293-2018·2018-07-11
Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation
Howmedica Osteonics Corp. is recalling specific LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.
Product
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040
Category
Medical Device
Distribution
Distributed nationwide

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