The latest headlines across every section, pulled from official and open-access sources.
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
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits. — Windstone Medical Packaging, Inc. · Class II · Ongoing
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
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in u… — Fresenius Kabi USA, LLC · Class I · Ongoing
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. — CareFusion 303, Inc. · 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
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
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc. — Baxter Healthcare Corporation · Class II · Ongoing
Sesame Seeds White were labeled as Curry Powder Sweet. — J and J Bunting, Inc · Class II · Ongoing
Potential contamination with foreign objects (metal pieces). — Straus Family Creamery · Class II · Ongoing
Products may be potentially contaminated with Salmonella. — JCB Flavors, LLC · Class I · Ongoing
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination — The Coffee Connexion Co., Inc · Class I · Ongoing
Potential contamination with foreign objects (metal pieces). — Straus Family Creamery · Class II · Ongoing
Products may be potentially contaminated with Salmonella. — JCB Flavors, LLC · Class I · Ongoing
Products may be potentially contaminated with Salmonella. — JCB Flavors, LLC · Class I · Ongoing
Undeclared allergen (sesame). Ingredients panel does not list sesame as sub-ingredient of Za'atar spice and Contains statement does not declare sesame. — Market of Choice Inc · Class II · Terminated
Product does not meet label claim for Vitamin E. — Sato Pharmaceutical Inc. · Class III · Ongoing
Products may be potentially contaminated with Salmonella. — JCB Flavors, LLC · Class I · Ongoing
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination — The Coffee Connexion Co., Inc · Class I · Ongoing
Salmonella. The firm was notified by the North Carolina Department of Agriculture that the product test positive for Salmonella. — Nassar Investment Company LLC · Class I · Ongoing
Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified. — Jesse Withrow · Class II · Completed
Possible carbon steel foreign material (1-2mm) — Creative Compounds, LLC · Class II · Ongoing
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination — The Coffee Connexion Co., Inc · Class I · Ongoing
Potential contamination with foreign objects (metal pieces). — Straus Family Creamery · Class II · Ongoing