FDA medical device recalls

38,657 recall records. Showing the 50 most recent by initiation date.

Z-1633-2026 — Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438; Class II ·Ongoing · Straumann USA LLC · 20260317
Z-1632-2026 — Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; Class II ·Ongoing · Straumann USA LLC · 20260317
Z-1804-2026 — Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryk… Class II ·Ongoing · Stryker Sustainability Solutions · 20260312
Z-1795-2026 — B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor Class II ·Ongoing · Brahms GmbH · 20260312
Z-1653-2026 — ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. Class II ·Ongoing · Siemens Medical Solutions USA, Inc · 20260310
Z-1692-2026 — Vue Motion V12. Product Number: 1017979. Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260305
Z-1782-2026 — COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073 Class II ·Ongoing · Cook Incorporated · 20260305
Z-1783-2026 — COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order N… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1792-2026 — COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Refer… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1776-2026 — COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Pa… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1787-2026 — COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Refere… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1781-2026 — COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Ord… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1786-2026 — COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775 Class II ·Ongoing · Cook Incorporated · 20260305
Z-1779-2026 — COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Or… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1769-2026 — Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max… Class II ·Ongoing · Tornier, Inc · 20260305
Z-1790-2026 — COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242 Class II ·Ongoing · Cook Incorporated · 20260305
Z-1775-2026 — COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 Class II ·Ongoing · Cook Incorporated · 20260305
Z-1788-2026 — COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; R… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1789-2026 — COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1777-2026 — COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1780-2026 — COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA,… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1791-2026 — COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1784-2026 — COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1785-2026 — Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G321… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1778-2026 — COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference… Class II ·Ongoing · Cook Incorporated · 20260305
Z-1631-2026 — Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: E… Class II ·Ongoing · Koven Technology, Inc. · 20260304
Z-1661-2026 — ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1675-2026 — Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1659-2026 — Allura Xper FD10C; System Code: 722001; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1678-2026 — Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1663-2026 — ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1669-2026 — Allura Xper FD20/20; System Code: 722038; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1671-2026 — Allura Xper FD20/15; System Code: 722058; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1667-2026 — ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1662-2026 — ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1670-2026 — Allura Xper FD20/20 OR Table; System Code: 722039; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1680-2026 — Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1677-2026 — Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1674-2026 — Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1665-2026 — ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1668-2026 — Allura Xper FD20/10; System Code: 722029; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1660-2026 — ALLURA Xper FD10F; System Code: 722002; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1666-2026 — ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1766-2026 — OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem Class II ·Ongoing · Oxoid Australia Pty Limited · 20260303
Z-1679-2026 — Azurion 5 M12; System Code: (1)722227, (2)722231; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1676-2026 — Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1673-2026 — Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1672-2026 — Allura Xper FD20/15 OR Table; System Code: 722059; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1664-2026 — ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; Class II ·Ongoing · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 20260303
Z-1614-2026 — Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. Class I ·Ongoing · Philips Respironics, Inc. · 20260302