fda regulated Recalls
1,320 recalls tagged with “fda regulated”.
Boston Scientific Pacemakers Recalled Over Software Flaw in Safety Architecture (2025)
Boston Scientific Pacemaker L231 Recalled; 63,851 Units in 2025
Boston Scientific Pacemakers Recalled for Software Safety Issue Affecting 12,326 Units (2025)
Great American Seafood Imports Co. Frozen Raw Shrimp Recall Covers 11,081 Cases (2025)
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
READYPREP PVP Iodine 10% Topical Antiseptic Recalled for Subpotent Drug (Medline)
FDA recalls READYPREP PVP, povodone-iodine 10% topical antiseptic. Medline Industries issued the nationwide recall. Subpotent drug is the reason. Consumers should stop using the product immediately.
Best Yet, Arctic Shores, and Great American Frozen Shrimp Recalled for Cs-137 Contamination (2025)
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
Hershey Creamery Green Mint Chip Bulk Ice Cream Recalled for Coliform Contamination (81 Units, 2025)
Product tested elevated coliform counts during routine testing
Boston Scientific ICEfx Cryoablation System Recalled for 19 Units Worldwide (2025)
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Chlorpromazine Hydrochloride 200 mg Recall Expanded After Packaging Contamination Found in 3,363 JDS
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Chlorpromazine Hydrochloride Recall 2025: 14,923 Bottles Over Packaging Contamination
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal 800mg/160mg Sulfamethoxazole and Trimethoprim Tablets Recalled for Foreign Packaging Material
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
B. Braun Lactated Ringers Injection 46,032 Containers Recalled Over Particulate Matter
Amneal Chlorpromazine Hydrochloride 25 mg 100-count Recalled in 2025 for Packaging Contamination
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Aesculap ELAN 4 Fixed Duraguard Recalled for Mislabeling (1 Unit, 2025)
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
CorNeat Vision EverPatch Recalled for Conjunctival Wound Dehiscence Risk (630 Units, 2025)
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Corneat Vision EverPatch+ 180-Unit Recall for Scleral Patch Dehiscence Risk (2025)
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Aesculap AG Recalls ELAN 4 Fixed Duraguard Long Mislabeling Devices (GB943R)
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Tampa Maid Foods Frozen Shrimp Recalled for Cs-137 Contamination (2025)
Tampa Maid Foods recalled 776 cases of Panko Style Breaded Butterfly Shrimp due to potential Cesium-137 contamination. The product was distributed to 16 states. Consumers should not eat the shrimp and should contact the company for refunds or replacements.