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

14301–14325 of 40112

HighFDA (Devices)·Z-1981-2021·2021-07-07
Monitor bracket assembly recalled for detachment hazard on CT imaging systems
Philips is recalling 1,301 monitor bracket assemblies for CT/PET-CT imaging systems due to shaft wear that could cause detachment from the suspension arm, potentially resulting in the monitor falling and serious injury.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1966-2021·2021-07-07
Edwards TruWave Pressure Monitoring Set Recalled Due to Tubing Detachment Risk
Edwards Lifesciences is recalling Edwards TruWave (3 cc)/VAMP Jr Pressure Monitoring Sets (Lot 63545959) due to a potential risk that pressure tubing may detach from the blood sampling system.
Product
Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-1991-2021·2021-07-07
PowerPICC Catheter Kits Recalled for Incorrect Micro-Introducer Components
Bard Access Systems is recalling 180 units of 5Fr PowerPICC Catheter kits because they contain incorrect micro-introducers.
Product
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1980-2021·2021-07-07
Philips Continuous CT Fluoroscopy Monitor Bracket Assembly Fall Risk
Philips is recalling 1,301 Monitor Bracket Assemblies due to shaft wear that could cause the assembly to detach from the ceiling suspension arm. This could result in the monitor falling and causing serious injury to patients, operators, bystanders, or service personnel.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1967-2021·2021-07-07
Dragonfly Laryngeal Surface Electrode recalled for sterilization process deviation
Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization process. Affected lot LS20G3274I was distributed in California, Massachusetts, and South Carolina.
Product
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1960-2021·2021-07-07
Edwards TruWave Pressure Monitoring Set Tubing Detachment Recall
Edwards Lifesciences is recalling Edwards TruWave pressure monitoring sets due to potential tubing detachment from the blood sampling system. No illnesses or injuries have been reported.
Product
Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
Category
Medical Device
Distribution
33 states
SevereFDA (Devices)·Z-1863-2021·2021-06-30
Nitric Oxide Delivery System Dosing Deficiency During Console Transitions
GENOSYL DS Nitric Oxide Delivery System is recalled for delivering below-intended doses during transitions between primary and backup consoles following a software update.
Product
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1934-2021·2021-06-30
Dexcom G6 Sensor 3-Pack Recalled for Temperature-Related Measurement Errors
Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.
Product
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1930-2021·2021-06-30
FREESTYLE LIBRE 14 DAY glucose monitoring system recalled for temperature exposure
Cardinal Health is recalling 8,959 glucose monitoring kits due to temperature exposure during shipping that may result in inaccurate readings. Affected devices were distributed nationwide.
Product
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1931-2021·2021-06-30
FreeStyle Libre 2 Glucose Monitoring System Recalled for Inaccurate Results
Cardinal Health is recalling FreeStyle Libre 2 glucose monitoring systems shipped between February and March 2021 due to temperature exposure during shipment that may cause inaccurate readings.
Product
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1905-2021·2021-06-30
SARS-CoV-2 IgG II reagent may produce falsely elevated results in certain software versions
This diagnostic reagent may multiply test results by 1000x in certain software versions, leading to falsely elevated readings. The Class II recall affects 13,337 units distributed in the US and internationally.
Product
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-1944-2021·2021-06-30
FilmArray Pneumonia Panel diagnostic test kits recalled for false results
BioFire Diagnostics is recalling 9 FilmArray Pneumonia Panel test kits due to manufacturing defects causing false positive and negative test results, as well as control failures.
Product
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1939-2021·2021-06-30
OneTouch Delica Lancets Recalled Due to Temperature Exposure During Shipping
Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.
Product
ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1946-2021·2021-06-30
Medical Action Curved Hemostats recalled due to flaking metal risk
Medical Action Industries is recalling curved hemostats distributed across 16 U.S. states due to a manufacturing defect causing potential metal flaking and discoloration.
Product
Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1904-2021·2021-06-30
Philips Allura Xper System power supplies may fail unexpectedly
Certain low-voltage power supplies in Philips Allura Xper interventional X-ray systems may fail, potentially causing loss of imaging functionality. 42 devices are affected worldwide.
Product
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1903-2021·2021-06-30
Blood Culture Identification Panel Recalled Due to Manufacturing Defect
BioFire BCID2 panels for FilmArray Systems are recalled due to manufacturing defects causing elevated rates of false negative results. Affected diagnostic kits may fail to detect infections in blood culture samples.
Product
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1902-2021·2021-06-30
Ventec VOCSN Ventilators May Shut Down Due to Component Failure
Ventec VOCSN ventilators may unexpectedly shut down or lose blower function during patient use due to component failure. This could prevent the device from providing ventilation therapy. About 1,934 devices are affected.
Product
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1938-2021·2021-06-30
OneTouch Ultra Test Strips Recalled for Potential Inaccurate Glucose Readings
Cardinal Health Inc. is recalling OneTouch Ultra Test Strips (item 3510443) because temperature excursions during shipping may have compromised glucose measurement accuracy.
Product
ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1933-2021·2021-06-30
Prefilled Pen Needles Recalled Due to Temperature Exposure During Shipping
Cardinal Health is recalling 1,599 boxes of prefilled pen needles that were exposed to low temperatures during shipping, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.
Product
BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1919-2021·2021-06-30
Ultrasound Probe Cover Kit Recalled for Lack of FDA Clearance
Exact Medical Manufacturing is recalling the Hays Innovation Ultrasound Probe Cover Kit because it lacks required FDA 510(k) clearance for use in body openings.
Product
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1924-2021·2021-06-30
Ultrasonic Probe Covers Recalled for Missing FDA Clearance
Exact Medical Manufacturing recalls 6,000 ultrasonic probe covers lacking FDA 510(k) clearance for use in body openings. The product was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Product
Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1949-2021·2021-06-30
FDA Recalls Medical Action Minor Procedure Trays for Flaking Metal on Hemostats
Medical Action Industries is recalling 31 cases of Minor Procedure Trays because hemostats in the kits may have flaking metal or brown spots that could compromise sterile surgical procedures.
Product
Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1940-2021·2021-06-30
OneTouchDelica Lancets Recalled Due to Temperature Exposure During Shipping
Cardinal Health Inc. is recalling OneTouchDelica Lancets 33G because devices were exposed to freezing temperatures (31.9°F) during shipping, which may cause inaccurate test results.
Product
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1910-2021·2021-06-30
Ultrasonic Transducer Covers Lack FDA Clearance for Body Cavity Use
Exact Medical Manufacturing is recalling 7,920 ultrasonic transducer probe covers distributed across six states and Puerto Rico because they lack required FDA 510(k) clearance for use in body cavities and surgical openings.
Product
6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1926-2021·2021-06-30
reSET-O Mobile App Recall: Software Defect Allows Incorrect Reward Access
Pear Therapeutics recalls the reSET-O mobile app due to a software defect that allowed patients with positive drug tests to access undeserved rewards. The flaw may undermine substance abuse treatment effectiveness.
Product
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Category
Medical Device
Distribution
16 states

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14301–14325 of 40112