Augmentation devices failed bacterial endotoxin testing.
Augmentation devices failed bacterial endotoxin testing.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact International Life Sciences or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for International Life Sciences recalls
Be the first to know. Free instant alerts to your inbox.
Artelon FlexBand Dynamic Matrix Ref: 31057. Reason: Augmentation devices failed bacterial endotoxin testing.. Classification: Class II. Quantity: N/A. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsGet instant alerts for recalls that affect you. Free forever.
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Rising Pharmaceuticals recalls 1,200 Temozolomide 5 mg capsules nationwide after a stability test found out-of-spec impurities. The drug is Rx-only, with NDC 16571-816-51 and lot 1TM0524003A. Stop using immediately and contact a healthcare provider for guidance.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Kirkman recalled 178 bottles of MAXIMUM Zone 1 4% Lidocaine Cream distributed nationwide in the U.S. by Dermal Source. The recall cites stability data that does not support the stated expiry date. Consumers and healthcare providers should stop using this product immediately and contact Kirkman for guidance.
HTO Nevada Inc. dba Kirkman recalled 243 bottles of MAXIMUM ZONE 2, 4% lidocaine cream distributed nationwide by Dermal Source. The recall cites stability data that does not support an expiry date. Consumers and healthcare providers should stop using this product immediately and contact Kirkman for guidance.
Cipla USA recalls 271 cartons of Nilotinib 150 mg capsules nationwide after stability tests show out-of-spec results. The issue affects description and appearance by visual inspection. Stop using and contact Cipla USA or a clinician for guidance.
HTO Nevada Inc. dba Kirkman recalls 27,380 bottles of FIVE-STAR VASOCAINE Spray distributed nationwide by Dermal Source. The recall cites stability data that does not support the product's expiry date. Stop using the spray and contact Kirkman or your healthcare provider for guidance.
Nilotinib capsules manufactured for Cipla USA are recalled nationwide after stability testing showed out-of-spec results. The failure involves description and appearance by visual inspection at six months of long-term stability. Patients and healthcare providers should stop using the product immediately and contact Cipla USA for guidance.