Recalls and safety alerts from the FDA, newest first.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. — B Braun Medical Inc · Class II · Ongoing
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient. — Siemens Medical Solutions USA, Inc · Class II · Ongoing
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
Due to incorrect functional length on device labeling. — Grace Medical, Inc. · Class II · Ongoing
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. — Becton Dickinson & Company · Class I · Ongoing
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. — Becton Dickinson & Company · Class I · Ongoing
The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in… — Oculus Technologies of Mexico, S.A. de C.V. · Class II · Ongoing
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. — B Braun Medical Inc · Class I · Ongoing
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. — Becton Dickinson & Company · Class I · Ongoing
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. — Becton Dickinson & Company · Class I · Ongoing
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient. — Siemens Medical Solutions USA, Inc · Class II · Ongoing
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. — Becton Dickinson & Company · Class I · Ongoing
Potential for the Cassette Loading Lever to break. — Fresenius Kabi USA, LLC · Class II · Ongoing
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. — CareFusion 303, Inc. · Class II · Ongoing
Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off. — Shimadzu Medical Systems · Class II · Ongoing
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives. — SSC- Surgical Specialties Corporation · Class II · Ongoing
Sterile wound dressing, lacks sterility assurance — DeRoyal Industries Inc · Class II · Ongoing
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. — CareFusion 303, Inc. · Class II · Ongoing
Temperature probe devices lack FDA clearance. — Covidien LLC · Class II · Ongoing
Temperature probe devices lack FDA clearance. — Covidien LLC · Class II · Ongoing
The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. — Kico Knee Innovation Company · Class II · Ongoing
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure. — Covidien, LP · Class II · Ongoing
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing