Class IIOngoingZ-2770-2026
Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Due to manufacturing issues, reperfusion catheters may fractures
Penumbra, Inc.CAJul 29, 2026
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 181–192 of 674 recalls
Class IIOngoingZ-2758-2026
Paragon 28, Inc. recalls P28 PHANTON INTRAMEDULLARY NAIL SYSTEM
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Paragon 28, Inc.COJul 29, 2026
Class IIOngoingZ-2753-2026
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Under Investigation by firm
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2752-2026
Boston Scientific Corporation recalls FARASTAR PFA Generator
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Under Investigation by firm
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2751-2026
Boston Scientific Corporation recalls FARASTAR Pulsed Field Ablation Generator
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Under Investigation by firm
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2750-2026
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Under Investigation by firm
Boston Scientific Corp…MNJul 29, 2026
Class IOngoingZ-2749-2026
Medline Industries, LP recalls MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc.…
Medline Industries, LPILJul 29, 2026
Class IOngoingZ-2748-2026
Medline Industries, LP recalls MEDLINE convenience kits labeled as: 1) C-SECTION
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc.…
Medline Industries, LPILJul 29, 2026
Class IOngoingZ-2747-2026
Medline Industries, LP recalls MEDLINE ANTERIOR HIP
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc.…
Medline Industries, LPILJul 29, 2026
Class IIOngoingZ-2741-2026
Maquet Cardiovascular, LLC recalls The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany,…
Maquet Cardiovascular,…NJJul 22, 2026
Class IIOngoingZ-2737-2026
Medline Industries, LP recalls Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF…
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach.…
Medline Industries, LPILJul 22, 2026
Class IIOngoingZ-2736-2026
Medline Industries, LP recalls Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYN…
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach.…
Medline Industries, LPILJul 22, 2026