State

Maine product recalls

19,713 recalls have nationwide distribution and so reach Maine. 0 additional recalls listed Maine specifically in their distribution scope.

About recalls in Maine

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Maine consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

826–850 of 19713

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-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-1961-2026·2026-05-06
Philips Ingenia Ambition X MRI Systems Stiffness Value Error Recall
Philips Ingenia Ambition X MRI systems with MR Elastography may produce incorrect stiffness values due to image reconstruction parameter errors, affecting diagnostic accuracy.
Product
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
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-0526-2026·2026-05-06
Alendronate Sodium Oral Solution Recalled for Out-of-Specification Assay Results
Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution 70 mg/75 mL due to out-of-specification assay results found in a limited number of bottles. The affected lot (AC2040A) was distributed nationwide.
Product
ALENDRONATE SODIUM — ALENDRONATE SODIUM (ALENDRONATE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1953-2026·2026-05-06
Philips Achieva 3.0T MR Elastography system stiffness value error recall
Philips is recalling the Achieva 3.0T with MR Elastography system due to potential stiffness value errors in image reconstruction when specific parameters are used, which may cause incorrect voxel size display in the default scan protocol.
Product
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1969-2026·2026-05-06
Philips MR 7700 MRE Upgrade MRI Equipment Stiffness Value Error Risk
Philips is recalling 15 units of its MR 7700 with MR Elastography upgrade due to potential stiffness value errors in MRI scans when specific image reconstruction parameters are used with the Resoundant algorithm.
Product
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2004-2026·2026-05-06
Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C) because the catheter may experience resistance when being advanced over the guidewire during use.
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
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-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 (Devices)·Z-1982-2026·2026-05-06
BD GasPak EZ CO2 Pouch System gas generating sachets underperforming
Becton Dickinson is recalling certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification.
Product
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1966-2026·2026-05-06
Philips SmartPath dStream 3.0T MRI Scanner Software Parameter Error Recall
Philips is recalling one unit of the SmartPath to dStream 3.0T MRI scanner with MR Elastography due to potential stiffness value calculation errors when specific image reconstruction parameters are used.
Product
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
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-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-2003-2026·2026-05-06
Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
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-1945-2026·2026-05-06
Kiwi Omni Vacuum Delivery System devices recalled for traction force gauge breakage
Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to complaints of device breakage at the traction force gauge to handle joint. The recall affects 49,175 devices distributed nationwide and internationally.
Product
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device desig
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1944-2026·2026-05-06
Vacuum Bag SU Large non-sterile specimen container recall
Milestone S.R.L. is recalling Vacuum Bag SU Large non-sterile specimen containers (Model 68409SS) due to the possibility of reagent leakage from the container. The recall affects approximately 61,600 units distributed worldwide.
Product
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0501-2026·2026-05-06
Similasan iVIZIA Sterile Lubricant Eye Drops Recall Due to Sterility Assurance
Thea Pharma, Inc. is recalling Similasan iVIZIA Sterile Lubricant Eye Drops due to the lack of assurance of sterility caused by manufacturing deviations found by the FDA.
Product
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
Category
Drug
Distribution
Distributed nationwide
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-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-1964-2026·2026-05-06
Philips MR 7700 MR Elastography device stiffness value error recall
Philips is recalling certain MR 7700 devices with MR Elastography due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause voxel size settings to display incorrectly.
Product
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1956-2026·2026-05-06
Philips Ingenia 1.5T MRI System Stiffness Value Calculation Error Recall
Philips Ingenia 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings due to image reconstruction parameter combinations. The error affects 54 units distributed worldwide.
Product
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
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