Recall

The U.S. Food and Drug Administration announced several significant updates today, addressing sterilization policies, drug approvals, and food safety measures to safeguard public health.   New...

Key TakeawaysDIGEMID has issued an alert regarding the illegal sale of Sculptra injections (poly-L-lactic acid) without a sanitary registration in Peru. The unregistered...

Key TakeawaysDIGEMID seized an unregistered Botox (Botulinum Toxin Type A) product found in a Peruvian customs warehouse. The product, manufactured by Allergan Pharmaceuticals...

Key TakeawaysOnly 30 out of 157 heart devices with Class I recalls underwent premarket testing. Devices often approved via 510(k) pathway with minimal...

Key TakeawaysBaxter Healthcare updates instructions for ExactaMix compounding device inlets due to particulate matter risk. Affected products remain in use but require strict...

Key TakeawaysBionpharma Inc. has issued a voluntary nationwide recall of a single batch of Atovaquone Oral Suspension due to potential bacterial contamination with...

Key TakeawaysThe FDA upgraded Fresenius Kabi's voluntary recall of Ivenix LVP administration sets to a Class I recall due to risks of uncontrolled...

Key TakeawaysThe FDA has warned consumers not to use SnoreStop Nasal Spray due to potential microbial contamination, which may pose serious health risks,...

Key TakeawaysAGEMED warns consumers about cosmetic products being sold without mandatory health notifications, putting user safety at risk. These unregulated products have not...

Key TakeawaysThe European Commission has recalled certain batches of cosmetic products due to chemical risks associated with BMHCA. This substance, banned in cosmetics,...

Key TakeawaysBreas Medical has issued updated instructions for Vivo 45 LS ventilators due to potential risks from elevated formaldehyde emissions, especially at higher...

Key TakeawaysMedtronic recalls certain McGrath MAC Video Laryngoscopes due to a risk of battery overheating and explosion. Affected devices should be removed and...

Key Takeaways:Defibtech has issued a recall for its RMU-2000 ARM XR Chest Compression Device due to reports of the device unexpectedly stopping compressions. ...

Key Takeaways:Medline Industries, LP, has recalled specific syringes within its convenience kits due to potential contamination, breakage, and leakage. The FDA has classified...

Key Takeaways:Inari Medical has updated the instructions for the ClotTriever XL Catheter due to severe adverse events, including patient deaths and injuries. The...