Minnesota recalls

Zimmer, Inc. is recalling certain Affixus 9 mm femoral nails (Model 815509300, Lot 66717550) used in hip and thigh bone fracture surgery. Some implants may have a thinner-than-expected diameter that could cause the nail to fracture over time, potentially requiring additional surgery.

Zimmer, Inc. is recalling a specific batch of Affixus Antegrade Femoral Nails (9 mm, 280 mm length, left Piriformis) used in thigh bone fracture repair. The affected implants may have a manufacturing defect that weakens the nail shaft and could cause it to break inside the leg. If this happens, patients may experience pain, improper bone healing, or need another surgery.

Zimmer has recalled certain Affixus Antegrade Femoral Nails (model 815609440) used in hip fracture surgery. Some implants may have a manufacturing defect that makes them thinner than intended, which could cause the implant to crack or break over time. This could lead to pain, improper healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails (9 mm, 420 mm length, left side) used in thighbone fracture surgery. Some implants may have a manufacturing defect that weakens the nail shaft, increasing the risk of the implant breaking inside the leg.

Zimmer Affixus Antegrade Femoral Nails (9 mm, 400 mm length, left side) may have a smaller-than-intended diameter along the shaft. This could cause the implant to weaken and break over time, leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific Affixus Antegrade Femoral Nailing System implants (model 815609380, 9 mm, 380 mm length, left side) because they may have a manufacturing defect that makes the shaft undersized. This defect could cause the implant to break over time, potentially requiring additional surgery.

Zimmer, Inc. recalled certain Affixus Antegrade Femoral Nails (9 mm, 360 mm length, left side) because the shaft may be undersized and could fracture over time. A fractured implant could cause pain, improper bone healing, or require additional surgery.

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.

A New Life Herbs Sinus Cap herbal supplement is being recalled because the product makes unapproved claims about treating sinus issues and lacks required supplement facts labeling. The FDA determined the product is misbranded and does not meet federal requirements for herbal supplements.

A New Life Herbs' Pain Away herbal supplement contains labeling that makes drug claims (like "analgesic" and "anti-inflammatory") without FDA approval. The product also lacks a required Supplement Facts label, making it misbranded. About 275 bottles were distributed across 13 states.

A New Life Herbs is recalling its Organic Ginger Root Herbal Supplement because the product makes unapproved drug claims on its label and is missing required Supplement Facts labeling. The product was sold in 50-capsule plastic bags in multiple states.

A New Life Herbs is recalling its Mullein flower alcohol tincture ear drops because the product makes unapproved claims about treating pain and infection, and the bottle lacks required supplement labeling. The FDA found 22 bottles (lot T553MF, expiring 12/28) distributed across multiple states.