State
20,096 recalls have nationwide distribution and so reach Maine. 0 additional recalls listed Maine specifically in their distribution scope.
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.
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing methods that lack FDA review and approval.
Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.
Merit Medical Systems is recalling 1,892 Prelude Sheath Introducer devices due to a labeling error: devices labeled as 7.5F are actually sized as 7F. The dimensional mislabeling could result in incorrect device selection during medical procedures.
American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.
Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.
Empower Pharmacy is recalling a pyridoxine (B6) injection solution because sterility assurance could not be confirmed. The recalled product is lot 609763 with a beyond-use date of 04/18/2025.
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.
American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.
The BD Phoenix 100 system may misidentify Escherichia coli in clinical samples, potentially leading to misdiagnosis and inappropriate patient treatment. Becton Dickinson is recalling 764 units distributed worldwide.
Bard Peripheral Vascular is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needles due to possible packaging damage from manufacturing that may compromise sterility.
The Ingenia Elition X MRI device may have loose screws that interfere with the horizontal tabletop, potentially delaying patient diagnosis and causing anxiety during extended bore exposure.
Boston Scientific has recalled 308 units of WallFlex and Agile esophageal stent systems due to the potential for delivery catheter tip detachment during stent placement. The affected devices are distributed worldwide.
Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.
Boston Scientific is recalling Wallflex and Agile esophageal stent systems worldwide due to the potential for delivery catheter tip detachment during placement. The recall affects 133 units distributed globally.
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
Boston Scientific is recalling Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment that could affect proper stent deployment during medical procedures.
American Contract Systems is recalling 60 Shoulder SESH18I medical convenience kits nationwide due to equipment failure that resulted in out-of-specification humidity readings, preventing sterilization assurance confirmation.
Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.
Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.
American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.
Karl Storz is recalling 78 endoscopes because their instructions for use contain reprocessing modalities that have not been reviewed or approved by the FDA.
Fujifilm mobile x-ray systems may fail to apply configured exposure settings or default to adult chest imaging parameters. This could result in inappropriate radiation exposure levels.
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.
Philips SmartPath dStream MRI devices have loose screws in the RF carrier assembly that may interfere with the moving tabletop, potentially delaying diagnosis. Affected units should be inspected and repaired immediately.