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

23151–23175 of 40175

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
ModerateFDA (Devices)·Z-2383-2018·2018-07-18
Arrow International Recalls VPS Rhythm ECG Accessory Packs Due to Labeling Issues
Arrow International is recalling 2,070 VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.
Product
VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2387-2018·2018-07-18
GE Medical Systems Recalls Innova IGS Fluoroscopic X-ray Systems
GE Medical Systems is recalling 102 Innova IGS fluoroscopic X-ray systems due to a defect that may cause X-ray abort errors, resulting in the loss of imaging mode during use.
Product
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-2423-2018·2018-07-18
Anika Hyalomatrix Wound Dressings Recalled for Packaging Degradation
Anika Therapeutics is recalling Hyalomatrix wound dressings because PVC in the packaging degraded during sterilization, potentially compromising product integrity.
Product
Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2382-2018·2018-07-18
Arrow International Recalls VPS Rhythm ECG Accessory Packs for Labeling Issues
Arrow International Inc. is recalling 2,070 units of VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.
Product
VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2385-2018·2018-07-18
Arrow International Recalls Midline Catheter Kits Due to Labeling Issues
Arrow International is recalling 2,070 Peripherally Inserted Midline Catheter Kits because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.
Product
Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2410-2018·2018-07-18
Ohio Medical Vacuum Regulator Recalled for Incomplete Quality Control Testing
Ohio Medical Corporation is recalling 11 Vacuum Regulator units because final quality control testing was not completed before distribution.
Product
Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2388-2018·2018-07-18
GE Medical Systems Recalls Discovery IGS 740 X-ray Systems
GE Medical Systems is recalling 102 Discovery IGS 740 systems because X-ray abort errors may cause loss of imaging mode during fluoroscopic use.
Product
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-2379-2018·2018-07-18
Smiths Medical Recalls BCI Advisor Vital Signs Monitors Due to Printing Defects
Smiths Medical ASD Inc. is recalling 10 BCI Advisor Vital Signs Monitors because certain printing modes may not function properly.
Product
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2428-2018·2018-07-18
bioMerieux Recalls mini VIDAS Systems Due to Performance Issues
bioMerieux is recalling 1,866 mini VIDAS systems because pump clogging and label displacement may cause erroneous test results.
Product
BioMerieux mini 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
ModerateFDA (Devices)·Z-2425-2018·2018-07-18
Dako PD-L1 IHC 22C3 pharmDx Recall for Storage Time Correction
Dako North America Inc. is recalling 1,051 PD-L1 IHC 22C3 pharmDx kits to correct instructions for use regarding storage time for specific tissue sections.
Product
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Category
Medical Device
Distribution
29 states
LowFDA (Devices)·Z-2384-2018·2018-07-18
Arrow International Recalls VPS TipTracker Stylet Accessory Due to Labeling Issues
Arrow International Inc. is recalling 2,070 units of the VPS TipTracker Stylet Accessory because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.
Product
VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC).…
Category
Medical Device
Distribution
Distributed nationwide
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

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23151–23175 of 40175