1,264 recalls tagged with “fda regulated”.
Olympus recalls 3,046 BF-P190 bronchovideoscopes sold nationwide in the US and 2,414 overseas. The recall centers on updated IFU guidance to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Clinicians and facilities should stop using the device immediately and follow Olympus recall instructions.
Ethicon Endo-Surgery recalled 3 ECHELON Linear Cutter Reload 80 mm Blue devices, Product Number GLC80, distributed internationally to the United Arab Emirates, after they were shipped unsterilized. The devices were shipped unsterilized, creating a potential infection risk. Healthcare providers should stop using the device immediately and await instructions from Ethicon Endo-Surgery.
Olympus Corporation of the Americas recalls the BRONCHOVIDEOSCOPE BF-1TQ170. The recall is active with 2,092 units in the outside US market and no US units affected. The action seeks updated instructions for safe use with laser and high-frequency therapy equipment. Healthcare providers should stop use and follow manufacturer recall instructions.
Boston Scientific recalled 59 Tenacio Pumps with InhibiZone worldwide, including the US and Canada. The devices may experience inflation and/or deflation performance issues. Patients and healthcare providers should stop using the device immediately and await recall instructions.
Olympus recalled 395 EVIS EXERA II bronchoscopes after updates revealed safety concerns. The bronchoscope's instructions for use with laser and coagulation equipment lacked clarity, posing high risks during procedures. Patients and healthcare providers must stop using this device and follow recall instructions immediately.
Olympus Corporation of the Americas recalls 5,221 units sold in the U.S. and 4,321 units overseas. The recall covers the EVIS EXERA III BRONCHOVIDEOSCOPE BF-H190. It flags updated instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Patients and healthcare providers should stop using the device immediately and follow recall instructions.
Olympus Corporation of the Americas recalled 916 BF-Q190 bronchovideoscopes in the United States and 1,402 outside the US. The recall seeks to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Stop using the device immediately and follow the manufacturer’s recall guidance.
Boston Scientific recalled the TENACIO Pump without InhibiZone (UPN 72404420) worldwide, including the US and Canada. The device may experience inflation and/or deflation performance issues. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions.
Olympus recalled 6,450 BF-P60 bronchofiberscopes worldwide after updated instructions clarify safe use with laser, argon plasma coagulation and high-frequency therapy devices. The recall covers 1,007 US units and 5,443 units outside the US. Healthcare providers should stop using the device immediately and follow manufacturer instructions. Contact Olympus Corporation of the Americas for guidance.
Olympus Corporation of the Americas recalls the BF-TE2 bronchofiberscope distributed nationwide in the United States. The recall updates the Instructions for Use to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Stop using the device immediately and follow the manufacturer’s recall instructions.
Insulet recalled 174,013 Omnipod 5 iOS app software units distributed nationwide in the United States. The recall cites a magnifying feature bug that can duplicate a single-digit entry. This could lead to bolus insulin dosing errors and hypoglycemia. Stop using the app immediately and follow recall instructions from Insulet or your healthcare provider.
Medline Recall: Excelsior Medical 0.9% Sodium Chloride Injection, USP, 10 mL fill prefilled saline flush syringes EMZ111240 is being recalled. The notice covers 8,267,150 syringes distributed across the United States and Canada. The risk is a concentration deviation of sodium chloride. Healthcare facilities should stop using the product and follow recall instructions. See the FDA recall page for完整
Abbott recalled 11,805 TactiFlex Sensor Enabled Ablation Catheters worldwide. The devices may detach the tip during removal from packaging. Healthcare providers and patients should stop using the device immediately and follow Abbott's recall instructions. Check with Abbott or your healthcare provider for instructions.
Abbott recalls 399 TactiFlex Sensor Enabled Ablation Catheters after reports of tip detachment during packaging removal. The recall covers devices worldwide. Stop using the device immediately and follow manufacturer instructions.
Abbott recalled 3,403 TactiFlex Sensor Enabled Ablation Catheters sold worldwide. The devices may detach a tip during removal from packaging. Hospitals and providers should stop using the devices and follow the manufacturer’s recall instructions.
Gina Marie Bakery LLC recalled 172 cases of Toasted Cherry Biscotti after undeclared Red 40 was found. The recall originated with a Connecticut notice and was reported to the FDA on 2025-09-10. Consumers who purchased this product should not consume it and should contact Gina Marie Bakery LLC for refund or replacement.
Abbott recalled 1,958 TactiFlex Sensor Enabled Ablation Catheters worldwide. A limited number of tip detachment events occurred during catheter removal from packaging. Patients and healthcare providers should stop using the device immediately and follow Abbott's recall instructions.
Gina Marie Bakery LLC recalls Vanilla with Apricot Jam Cookies due to undeclared artificial colorings Red 40 and Yellow 6. The recall, initiated by the state of Connecticut and notified to the FDA, involves 172 cases at 20 containers per case. FDA-listed recall status is ACTIVE with no reported incidents yet.
Goot Essa recalled 62 lbs of Der Mutterschaf Cheese, Sheep Tomme Style, produced in batch #33 at plant #26476, with exp. 12/24/2025. The recall is active after a positive Listeria monocytogenes test. Consumers should not consume this cheese and should contact the company for refund or replacement.
Gina Marie Bakery LLC recalls 172 cases of Vanilla Chocolate Dipped Cookies after undisclosed Red 40 pigment was found. The recall was initiated by the state of Connecticut and notified to FDA on 2025-09-10. Consumers who bought the cookies should not eat them and should seek refunds or replacements.