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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

951–975 of 30633

ModerateFDA (Drugs)·D-0505-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston LLC has recalled fentanyl citrate injectable solution (1250 mcg/25mL) distributed nationwide due to cGMP deviations. The recall involves 50 syringes from Lot 011226204250063, expiring 05/14/2026.
Product
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2037-2026·2026-05-06
Medline medical procedure kits recalled for endotoxin contamination
Medline is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels. The affected in-market product may be out-of-specification for endotoxin.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medli
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1983-2026·2026-05-06
BD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
Becton Dickinson & Co. is recalling certain lots of BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification, potentially affecting microbiologic laboratory testing.
Product
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1985-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral Left Size 4 Cement prosthetic components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1968-2026·2026-05-06
Philips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors
Philips is recalling three models of SmartPath to Ingenia Elition X with MR Elastography devices due to potential stiffness value errors when specific image reconstruction parameters are combined with Resoundant's algorithm.
Product
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1958-2026·2026-05-06
Philips Ingenia 3.0T MRI System with Elastography Software Recall
Philips Ingenia 3.0T MRI systems with MR Elastography software may display incorrect stiffness values and voxel size settings when specific image reconstruction parameters are used, potentially affecting diagnostic accuracy.
Product
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0508-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma is recalling fentanyl citrate injectable solution (50 mcg/5mL, NDC 73702-202-15) nationwide due to cGMP manufacturing deviations. The recall affects 50 syringes from Lot 020226202150202 with expiration date 05/05/2026.
Product
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1949-2026·2026-05-06
Genius Review Station Display Modified Outside Validated Configuration
Hologic is correcting Genius Review Station displays (model CMP-01669) that were modified by users outside the FDA-cleared configuration. The devices need restoration to validated settings per the manufacturer's Operator's Manual.
Product
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1962-2026·2026-05-06
Philips Ingenia Elition S MRI stiffness value error correction
Philips Ingenia Elition S MRI systems with MR Elastography may display incorrect voxel size settings in the default scan protocol when certain image reconstruction parameters are used, potentially leading to stiffness value errors.
Product
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1965-2026·2026-05-06
Philips SmartPath to dStream MR Elastography System Reconstruction Error
Philips is recalling certain SmartPath to dStream 1.5T MR Elastography systems due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause incorrect voxel size settings in the default MRE scan protocol.
Product
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2014-2026·2026-05-06
Medline Neuro Sponges in Medical Procedure Kits Recalled for Endotoxin
Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges (ANGIO PACK-LF) due to higher-than-expected endotoxin levels that may exceed specifications.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1988-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling 3 units of ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM due to external sterile packaging adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0509-2026·2026-05-06
CVS Lidocaine Wound Gel recalled for failed pH specifications
CVS Lidocaine Wound Gel is being recalled because it failed pH specifications. The affected product is distributed nationwide.
Product
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1997-2026·2026-05-06
Heraeus PALAMIX uno Dental Material Mixing Rod Loose Risk Recall
Heraeus Medical is recalling PALAMIX uno dental material because the mixing rod may come loose during mixing in units older than 1.5 years. The shelf life has been reduced from 3 years to 1.5 years.
Product
Heraeus, PALAMIX uno. Material Number: 66057893.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0494-2026·2026-05-06
Levocarnitine Injection USP Missing Label Recall
American Regent, Inc. is recalling Levocarnitine Injection USP (1 g/5 mL) due to missing labeling on certain lots. The affected product was distributed nationwide.
Product
LEVOCARNITINE — LEVOCARNITINE (LEVOCARNITINE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1998-2026·2026-05-06
Heraeus PALAMIX duo dental mixing system batches worldwide recall
Heraeus Medical is recalling PALAMIX duo dental mixing units (Material Number 66057897) because the mixing rod may come loose from its lock during use in units older than 1.5 years. The shelf life is being reduced from 3 years to 1.5 years.
Product
Heraeus, PALAMIX duo. Material Number: 66057897.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V377000·2026-05-05
[pending] 2025 LION LIONC
Pending LLM rewrite. Source: NHTSA 24V377000.
Product
LION — 2025 LION LIONC
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·26V283000·2026-05-05
[pending] 2021 TESLA MODEL Y
Pending LLM rewrite. Source: NHTSA 26V283000.
Product
TESLA — 2021 TESLA MODEL Y
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V378000·2026-05-05
[pending] 2023 GRAND DESIGN SOLITUDE
Pending LLM rewrite. Source: NHTSA 24V378000.
Product
GRAND DESIGN — 2023 GRAND DESIGN SOLITUDE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V304000·2026-05-04
[pending] 2024 NISSAN SENTRA
Pending LLM rewrite. Source: NHTSA 24V304000.
Product
NISSAN — 2024 NISSAN SENTRA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V257000·2026-05-04
[pending] 2022 VOLVO VN
Pending LLM rewrite. Source: NHTSA 25V257000.
Product
VOLVO — 2022 VOLVO VN
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V302000·2026-05-04
[pending] 2021 MINI COOPER SE
Pending LLM rewrite. Source: NHTSA 24V302000.
Product
MINI — 2021 MINI COOPER SE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V301000·2026-05-04
[pending] 2022 NEWMAR BAY STAR
Pending LLM rewrite. Source: NHTSA 24V301000.
Product
NEWMAR — 2022 NEWMAR BAY STAR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V254000·2026-05-04
[pending] 2025 MERCEDES-BENZ G 580
Pending LLM rewrite. Source: NHTSA 25V254000.
Product
MERCEDES-BENZ — 2025 MERCEDES-BENZ G 580
Category
Vehicle
Distribution
Distributed nationwide
HighUSDA FSIS·PHA-05042026-01·2026-05-04
Giovanni Rana Ravioli Pasta Contains Undeclared Shellfish Allergen
USDA FSIS issued a public health alert for Giovanni Rana ravioli sold at Costco in Maryland and New Jersey. Products labeled as beef and burrata actually contain shrimp in lobster sauce, an undeclared shellfish allergen.
Product
Rana Meal Solutions, LLC — FSIS Issues Public Health Alert for Ravioli Pasta With Beef Sauce Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
2 states

Filters

951–975 of 30633