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U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

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476–500 of 26383

ModerateFDA (Devices)·Z-2008-2026·2026-05-06
Medline Neuro Sponges recalled for out-of-specification endotoxin levels
Medline Industries is recalling Medline Neuro Sponges in multiple sizes worldwide after internal review found higher-than-expected endotoxin levels in representative product samples.
Product
Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3. Neu
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0502-2026·2026-05-06
Injectable Phenylephrine Hydrochloride Solution Recall Due to cGMP Deviations
Wells Pharma of Houston LLC is recalling Phenylephrine Hydrochloride Injectable Solution, 40 mg, 250 mL IV bags nationwide due to cGMP deviations. The recall affects 13,070 IV bags with multiple lot numbers and expiration dates through July 2026.
Product
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1980-2026·2026-05-06
Dimension Creatinine Flex Reagent Cartridge Recalled for Imprecision Results
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine test results that could be erroneously increased or decreased.
Product
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1946-2026·2026-05-06
Disposable Mixing Bowls with Spatula recalled for compromised sterile barrier
Zimmer, Inc. is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) due to package seal defects that may compromise the sterile barrier. Ten complaints have been received identifying incomplete seals, wrinkles, or peeling seals.
Product
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2002-2026·2026-05-06
Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems is recalling the Philips Bridge Prep Kit (Lot K12-09098B) because the catheter may experience resistance when being advanced over the guidewire.
Product
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1957-2026·2026-05-06
Philips Ingenia 1.5T CX MRI Machine MRE Stiffness Measurement Error
Philips is recalling the Ingenia 1.5T CX MRI machine with MR Elastography because certain image reconstruction parameters may cause stiffness value measurement errors in the default scan protocol.
Product
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1950-2026·2026-05-06
HiResolution Bionic Ear Battery Pak Fails Safety Door Compliance
Advanced Bionics is recalling HiResolution Bionic Ear System M Zn-Air Battery Paks because the non-tamperproof battery door does not require a tool to open, violating safety standards. The issue affects 45,173 units distributed worldwide.
Product
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1959-2026·2026-05-06
Philips Ingenia 3.0T CX MRI System MR Elastography Software Issue
Philips is recalling Ingenia 3.0T CX MRI systems with MR Elastography due to potential stiffness value errors caused by specific image reconstruction parameters and Resoundant algorithm settings, resulting in incorrect voxel size displays in the default MRE scan protocol.
Product
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1986-2026·2026-05-06
Depuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Compromise
Depuy Synthes is recalling ATTUNE Revision Hinge Femoral components because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0504-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston is voluntarily recalling 2,940 IV bags of fentanyl citrate injectable solution due to cGMP (current good manufacturing practice) deviations. The product was distributed nationwide.
Product
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1967-2026·2026-05-06
Philips SmartPath to dStream MR Elastography Software Parameter Error
Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.
Product
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1952-2026·2026-05-06
Philips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall
Philips Achieva 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings when certain image reconstruction parameters are used together, potentially affecting diagnostic accuracy.
Product
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0500-2026·2026-05-06
iVIZIA Dry Eye Lubricant Drops Recalled for Sterility Assurance
Thea Pharma, Inc. is recalling iVIZIA Dry Eye (Povidone 0.5%) lubricant eye drops nationwide due to the FDA's discovery of manufacturing process deviations that affect the product's sterility assurance.
Product
IVIZIA DRY EYE — IVIZIA DRY EYE (POVIDONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0506-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recall Due to cGMP Deviations
Wells Pharma of Houston is recalling fentanyl citrate injectable solution (1000 mcg/50 mL) due to current good manufacturing practice (cGMP) deviations. The recall affects 150 syringes distributed nationwide.
Product
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0503-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma is recalling fentanyl citrate injectable solution (1000 mcg/100 mL, 10 mcg per mL) distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 4,030 IV bags with various lot numbers and expiration dates between April and June 2026.
Product
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1993-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral implant sterility concern
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT SZ 8 CEM implants due to external sterile packaging adhered to internal sterile packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1955-2026·2026-05-06
Philips Evolution 3.0T MR Elastography upgrade stiffness calculation error
Philips Evolution upgrade 3.0T with MR Elastography systems may produce incorrect stiffness values when specific image reconstruction parameters are used, causing voxel size settings to display smaller than intended.
Product
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
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-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 (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-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 (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 (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