State

Maine product recalls

20,364 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.

14476–14500 of 20364

SevereFDA (Devices)·Z-0926-2023·2023-01-25
Medical device controller software update addresses critical failure
Cardiac Assist is issuing a software update for LifeSPARC Controller units that may experience critical failure causing the system to freeze, crash, or lose display functionality. Affected units are identified by specific serial numbers.
Product
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0885-2023·2023-01-25
Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly
The Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly when blood enters the device through a compromised balloon catheter during use.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0969-2023·2023-01-25
Cardinal Health Jackson-Pratt Channel Drain: Multiple Performance Defects
Cardinal Health is recalling Jackson-Pratt Channel Drains due to multiple reported performance defects including dull trocars, lack of flexibility, missing radiopacity, and broken tips. These issues may compromise insertion and drain function.
Product
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0978-2023·2023-01-25
Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Issues
Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. No injuries have been reported.
Product
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2023·2023-01-25
Cardinal Health Jackson-Pratt Surgical Drains Recalled for Multiple Defects
Cardinal Health recalls Jackson-Pratt Channel Drains due to reported defects including non-visibility on imaging, dull insertion trocars, reduced flexibility, and broken drain tips.
Product
Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0133-2023·2023-01-25
Drug Recall: Artificial Tears Eye Ointment Due to Manufacturing Deviations
Akorn, Inc. is recalling Artificial Tears Ointment (1.16 million tubes nationwide) due to manufacturing practice deviations. The firm voluntarily initiated this recall.
Product
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0982-2023·2023-01-25
Jackson-Pratt Wound Drain Recalled for Performance Issues
Cardinal Health recalls Jackson-Pratt Channel Drains (15 Fr) due to performance issues: broken tips, dull trocars, lack of radiopacity, and reduced flexibility affecting surgical wound drainage.
Product
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0128-2023·2023-01-25
Prescription Anesthetic Drug Recalled for Subpotent Epinephrine Content
Fresenius Kabi is recalling Sensorcaine anesthetic injections nationwide due to subpotent epinephrine content. Affected batches may not provide adequate anesthesia or hemostasis during procedures.
Product
SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0998-2023·2023-01-25
FDA Recalls Thoracic Stent-Graft Systems Over Manufacturing Size Defect
Bolton Medical has recalled 640 units of RELAY PRO thoracic stent-graft systems worldwide because the products may be shorter than their packaging indicates.
Product
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0995-2023·2023-01-25
Vasoshield Syringe Ink Chips May Cause Embolic Events
Ink on the Vasoshield syringe may chip off, potentially causing blood clots and foreign body reactions in patients. About 9,817 devices are affected.
Product
Hemopro 2 with Vasoshield, Model VH-4001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0129-2023·2023-01-25
Local anesthetic Sensorcaine vials recalled for subpotent epinephrine
Fresenius Kabi is recalling Sensorcaine-MPF local anesthetic vials due to subpotent epinephrine levels. The affected batch (31,600 vials) was distributed nationwide.
Product
SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0980-2023·2023-01-25
Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects
Cardinal Health is recalling 750 units of Jackson-Pratt Channel Drains (10 mm) due to multiple performance issues including broken drain tips, lack of radiopacity, dull trocars, and reduced flexibility that could affect surgical outcomes.
Product
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0976-2023·2023-01-25
Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects
Cardinal Health Jackson-Pratt Channel Drains are recalled for performance defects including dull trocars, broken tips, lack of flexibility, and lack of radiopacity. 220 units are affected.
Product
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0956-2023·2023-01-25
ARTIS medical imaging systems recalled for mechanical connection failure
Siemens ARTIS pheno and ARTIS icono imaging systems are recalled because the mechanical connection between the tabletop and table base may fail. The recall affects 550 units distributed worldwide.
Product
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0967-2023·2023-01-25
Cardinal Health Jackson-Pratt Channel Drains Recalled for Performance Defects
Cardinal Health is recalling 1,150 Jackson-Pratt Channel Drains due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips affecting post-surgical wound drainage.
Product
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0132-2023·2023-01-25
FDA Recalls Akorn AK-POLY-BAC Eye Ointment for CGMP Violations
Akorn Inc. voluntarily recalls 36,025 tubes of AK-POLY-BAC Bacitracin/Polymixin B eye ointment nationwide due to manufacturing process deviations affecting product quality and sterility.
Product
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0986-2023·2023-01-25
Cardinal Health Jackson-Pratt Drain Recalled for Performance Defects
Cardinal Health is recalling Jackson-Pratt Channel Drains (15 Fr, REF JP-2228) due to multiple performance issues including dull trocars, broken wound tips, lack of radiopacity, and inflexibility. The recall affects approximately 15,493 units distributed worldwide.
Product
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0127-2023·2023-01-25
Injectable Anesthetic Sensorcaine Recalled for Subpotent Epinephrine
Sensorcaine injectable anesthetic is being recalled because testing showed the epinephrine component is below the required potency level. No illnesses or injuries have been reported.
Product
SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0957-2023·2023-01-25
Mobile CT Scanner Injury Risk During Reverse Transport
Mobius Imaging recalls the MobiCT-32 AIRO Mobile CT Scanner after one untrained user was injured while moving the unit in reverse. The manufacturer will add warning labels to improve instructions for safe reverse transport.
Product
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0153-2023·2023-01-25
Proparacaine Ophthalmic Solution Recalled for Manufacturing Quality Deviations
Akorn is voluntarily recalling Proparacaine Ophthalmic Solution nationwide due to Current Good Manufacturing Practice deviations.
Product
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0985-2023·2023-01-25
Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects
Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The recall affects 7,129 units distributed worldwide.
Product
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0975-2023·2023-01-25
Cardinal Health Jackson-Pratt Channel Drain recalled for performance defects
Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm, model JP-2212) due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.
Product
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0984-2023·2023-01-25
Cardinal Health Jackson-Pratt Channel Drains recalled for multiple performance defects
Cardinal Health is recalling 2,277 Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. These defects may affect the drain's function and clinical performance.
Product
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0165-2023·2023-01-25
Prescription Rifampin Capsules Recalled Due to Failed Quality Specifications
Amerisource Health Services is recalling Rifampin Capsules USP 300 mg nationwide due to failed impurities and degradation specifications. Affected patients should contact their healthcare provider before using remaining inventory.
Product
RIFAMPIN — RIFAMPIN (RIFAMPIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0141-2023·2023-01-25
Ketorolac Tromethamine ophthalmic solution recalled due to manufacturing deviations
Akorn is recalling Ketorolac Tromethamine Ophthalmic Solution nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers of the 0.5% formulation.
Product
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
Category
Drug
Distribution
Distributed nationwide