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
2026 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 349–360 of 2,088 recalls
Class IIOngoingZ-2757-2026
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH CLEAR OUS
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2756-2026
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH (CLEAR) - US
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2755-2026
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH CLEAR
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2754-2026
Boston Scientific Corporation recalls FARADRIVE Steerable Sheath Clear IDE
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Boston Scientific Corp…MNJul 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