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

21026–21050 of 40339

HighFDA (Devices)·Z-1133-2019·2019-04-24
BioFire FilmArray BCID Panel Recall for False Positive Blood Culture Results
BioFire Diagnostics is recalling FilmArray BCID Panels used with specific BACT/ALERT blood culture bottles due to an increased risk of false positive results for Enterobacteriaceae and E. coli.
Product
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1197-2019·2019-04-24
Abbott Alinity c Processing Module Recalled for Safety Interlock Defect
Abbott is recalling 559 Alinity c Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.
Product
Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1180-2019·2019-04-24
Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
Gyrus ACMI is recalling Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.
Product
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1187-2019·2019-04-24
Gyrus ACMI Recalls Diego Elite Malleable Monopolar Blades
Gyrus ACMI is recalling 161 Diego Elite Malleable 4mm Standard Monopolar Blades because they may allow unintended RF energy activation when used with Diego Elite consoles.
Product
Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1199-2019·2019-04-24
GE Healthcare Recalls Innova IGS 630 Angiographic X-Ray System
GE Healthcare is recalling one Innova IGS 630 angiographic X-ray system because a specific user action may cause a loss of imaging function.
Product
Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1192-2019·2019-04-24
Medrobotics Flex Robotic System Obturators Recalled for Weld Failure Risk
Medrobotics is recalling 24 Flex Robotic System obturators because a weld may break, causing the rod to separate from the cone.
Product
Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1137-2019·2019-04-24
bioMerieux Recalls Vitek 2 Test Kits Due to False ESBL Results
bioMerieux is recalling Vitek 2 test kits because they may incorrectly identify Escherichia coli as having an ESBL phenotype.
Product
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1145-2019·2019-04-24
Roche Bilirubin Total Gen.3 Recalled for Potential Medical Risk
Roche Diagnostics is recalling Bilirubin Total Gen.3 assays due to new endogenous interference claims that may pose a potential medical risk.
Product
Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1181-2019·2019-04-24
Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
Gyrus ACMI is recalling 82 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.
Product
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1191-2019·2019-04-24
Medrobotics Flex Robotic System Obturators Recalled for Weld Failure Risk
Medrobotics is recalling 35 Flex Robotic System obturators because a weld may break, causing the rod to separate from the cone.
Product
Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1146-2019·2019-04-24
Roche Lactate Gen.2 Recalled Due to Endogenous Interference Claims
Roche Diagnostics is recalling Lactate Gen.2 reagents because new endogenous interference claims may affect test accuracy on specific analyzers.
Product
Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1148-2019·2019-04-24
Bioventus Recalls Bioactive Bone Graft Putty Due to Sterility Risk
Bioventus is recalling 10,793 units of Bioactive Bone Graft Putty because sterile pouches may puncture during transit, potentially introducing non-sterile devices and causing patient infection.
Product
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-1184-2019·2019-04-24
Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
Gyrus ACMI is recalling 193 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with specific consoles.
Product
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1200-2019·2019-04-24
GE Healthcare Recalls Innova IGS 630 X-Ray Systems for Imaging Loss
GE Healthcare is recalling 49 Innova IGS 630 Interventional Fluoroscopic X-Ray Systems due to a potential loss of x-ray imaging function when changing the field of view while releasing the footswitch.
Product
Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1183-2019·2019-04-24
Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
Gyrus ACMI is recalling 13 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with compatible consoles.
Product
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1201-2019·2019-04-24
GE Healthcare Recalls Innova IGS 6 X-Ray Systems Due to Imaging Loss
GE Healthcare is recalling 22 Innova IGS 6 Interventional Fluoroscopic X-Ray Systems because they may lose x-ray imaging function during specific field of view changes.
Product
Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1139-2019·2019-04-24
Pintler Medical Recalls 24 Warming Pads Due to Malfunction
Pintler Medical LLC is recalling 24 warming pads used in operating rooms because they malfunction. The affected units were distributed to facilities in Wisconsin.
Product
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1132-2019·2019-04-24
Wilson-Cook Recalls Acusnare Polypectomy Snares Due to Loop Retraction Issues
Wilson-Cook Medical Inc. is recalling 34,456 Acusnare Polypectomy Snares because the snare loop may not completely retract or may misshape.
Product
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1178-2019·2019-04-24
Olympus Diego Elite Console Recall for Unintended RF Energy Activation
Gyrus ACMI is recalling Olympus Diego Elite Consoles because they may inadvertently activate the RF energy feature when used with specific blades.
Product
Olympus Diego Elite Console MDCONS 100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1196-2019·2019-04-24
Abbott Alinity i Processing Module Recalled for Safety Interlock Defect
Abbott is recalling Alinity i Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.
Product
Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1150-2019·2019-04-24
Integra Salto Talaris Ankle Prosthesis Recalled for Incorrect Labeling
Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle implants because the labels list an incorrect metallic coating material symbol.
Product
Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-1144-2019·2019-04-24
Philips Brilliance iCT CT Scanners Recalled for Collimator Compensator Failure
Philips is recalling two Brilliance iCT CT scanners because a component may fail, causing image artifacts. The devices were distributed only to China and the UK.
Product
Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1173-2019·2019-04-24
Integra Talar Dome Total Ankle Prosthesis Recalled for Labeling Error
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Product
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-1138-2019·2019-04-24
Topcon IMAGEnet 6 Software Recalled for Patient Data Display Error
Topcon Medical Systems is recalling IMAGEnet 6 software due to a defect that may display incorrect patient identification information alongside thumbnails.
Product
IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1166-2019·2019-04-24
Integra Talar Dome Total Ankle Prosthesis Recalled for Labeling Error
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Product
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
Category
Medical Device
Distribution
26 states

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21026–21050 of 40339