Maine recalls

Zimmer, Inc. recalled specific lots of Affixus Antegrade Femoral Nails (9 mm, 340 mm, Left) because the implant shaft may be undersized. This could cause the nail to break over time after surgical implantation, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer has recalled certain Affixus 9 mm femoral nails (320 mm length, left side) because the metal shaft may be undersized. This defect could cause the implant to crack over time, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling certain Affixus 9 mm, 300 mm Left Trochanteric Femoral Nails (Model 815609300, Lot 66717600) because the implant shaft may be undersized, which could cause it to crack or break inside the body. If the nail fractures, patients may experience pain, improper bone healing, tissue damage, or need another surgery.

Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (model 815509440, 440 mm length) because the implant shaft may be undersized. This defect could cause the nail to break over time, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific lots of the Affixus Antegrade Femoral Nailing System (a surgical implant used to stabilize thighbone fractures) because some units may have a manufacturing defect that could cause the implant to crack or break over time. If the implant breaks, it could lead to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails (model 815509400, 9 mm, 400 mm length) used in thigh bone surgery. Some implants may have a manufacturing defect that makes the shaft undersized, which could cause the nail to fracture over time.

Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (9 mm, 380 mm length, right-sided) because the implant shaft may be undersized. This manufacturing defect could cause the implant to break inside the body, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. recalled certain Affixus 9 mm femoral nails (model 815509360, length 360 mm) because the shaft may be undersized and prone to breaking. If the implant fractures, it could cause pain, improper bone healing, tissue damage, or require additional surgery.

Zimmer, Inc. recalled 22 Affixus Antegrade Femoral Nails (9 mm, 340 mm length, right-sided) because the implants may have an undersized shaft diameter that could cause the nail to break inside the leg over time. If the implant fractures, it may cause pain, improper bone healing, tissue damage, or require additional surgery.

Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (9 mm, 320 mm length, right-sided) because the implant shaft may be undersized. This manufacturing defect could cause the nail to break over time, which may lead to pain, bone healing problems, or the need for additional surgery.

ICU Medical's LifeShield Infusion Safety Software v2.2 has a software issue that limits concentration settings to one decimal place instead of three. This may force users to set drug limits differently than the manufacturer recommends, potentially causing patients to receive too much or too little medication.

ICU Medical's LifeShield Drug Library Management software version 2.2.1 has a problem where the Change Summary review tool stops working correctly after a library migration. This affects only customers who upgraded from version 2.1x and use Plum Duo v1.1 infusion pumps. When the review tool doesn't work, staff may not catch errors in pump settings.

A faulty motor connector in certain da Vinci 5 surgical systems may cause Error 23062, which locks the surgeon console's ergonomic adjustments (viewer, headrest, armrest, and pedal position). This could delay or disrupt a scheduled surgical procedure. The issue affects 144 systems across 30 states.

The Stryker CranialMask Tracker, a surgical tracking device used during head and neck procedures, can display a software error message when activated in the operating room, making it unusable. This affects 320 units worldwide across specific lot numbers. No injuries have been reported.

BD Pyxis automated medication dispensing cabinets used in hospitals and pharmacies received a firmware update that caused certain drawers to fail. When a drawer fails, staff may have difficulty accessing or restocking medications, which could delay patient care.

Alcon Custom Pak sterile surgical procedure packs used in eye surgery may have incomplete seals that could compromise sterility. This affects 151 units across specific lot numbers. No injuries have been reported.

Draeger, Inc. is recalling certain Vapor 3000 anesthetic vaporizers (Model M36500) because a component inside was not built to specification and contains impurities. This affects 188 units with specific serial numbers distributed worldwide. No injuries have been reported.

Draeger, Inc. is recalling certain Vapor 2000 anesthetic vaporizers because an internal component was manufactured with impurities and did not meet quality specifications. The affected units are identified by specific serial numbers and were distributed worldwide, including across the United States.

AGFA's DR 800 digital X-ray system can deliver higher radiation doses than the FDA allows during certain fluoroscopy procedures. This happens when the frame rate is increased on the NX workstation without proper safety features enabled. About 35 systems are affected nationwide.

Choceur Cookie Butter Holiday Bark sold at Aldi contains pecan that is not listed on the label. People with pecan allergies could have a serious reaction if they eat this product. The recall affects specific lot numbers with best-by dates through June 2026.

Choceur Pecan Cranberry & Cinnamon Holiday Bark contains wheat that is not listed on the label. People with wheat allergies or celiac disease could have a serious reaction if they eat this product. The affected bags were sold at Aldi stores nationwide.

Merck has recalled specific lots of Noxafil Powdermix, a prescription antifungal medication, because some packets may contain metal particles. This affects 845 kits distributed nationwide. No injuries have been reported.

Merck has recalled a limited lot of Emend (aprepitant) 125 mg oral suspension due to the potential presence of metal particles in the product. This affects 3 single-dose kits with lot number Z014503 and expiration date 11/15/2027 distributed nationwide.

Abbott Laboratories is recalling certain Alinity ci-series System Control Modules with software version 3.6.1 or lower due to a performance issue that could produce inaccurate lab test results. The issue affects multiple analytes and was discovered during Abbott's internal testing.

Cepheid's Xpert BCR-ABL Ultra diagnostic test kits may produce inaccurate results when testing blood samples with very high white blood cell counts (above 30,000 cells). This affects certain lot numbers distributed across the US and internationally. No injuries have been reported.

Cepheid's Xpert BCR-ABL Ultra diagnostic test kits may give inaccurate results when testing blood samples with very high white blood cell counts (over 30,000 cells). This affects specific lot numbers distributed across the US and internationally. No injuries have been reported.

Medtronic MiniMed InPen App users on Android (versions 7.5.0, 7.5.1, and 8.0.0) may lose insulin reminders if they uninstall and reinstall the app. The notification settings screen doesn't appear during setup, preventing notifications from overriding your phone's mute or Do Not Disturb mode. This could delay insulin therapy.

Smith & Nephew is recalling certain BIOSURE HA Screws (6mm x 20mm bone fixation screws) due to a labeling error on affected units. The screws themselves are safe, but the packaging labels on a small number of units contain incorrect information. No injuries have been reported.

Myofunctional Research Company USA distributed Myosa for Kids mouthguards in the U.S. without FDA approval. The company mistakenly sold approximately 436 units of these devices, which are designed for children ages 3–15 to help with breathing and myofunctional disorders. No injuries have been reported.

Rocket Medical's 20Fg Seldinger chest tube procedure tray has misleading instructions that may prevent proper securing of the device. This could cause the tube to fall out during use. The issue affects 246 units distributed across multiple U.S. states and internationally.