Class IIOngoingZ-2465-2026
ConMed Corporation recalls ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip
Potential for overpressure alerts.
ConMed CorporationNYJun 24, 2026
2026 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 637–648 of 2,088 recalls
Class IIOngoingZ-2464-2026
ConMed Corporation recalls ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip
Potential for overpressure alerts.
ConMed CorporationNYJun 24, 2026
Class IIOngoingZ-2462-2026
Howmedica Osteonics Corp. recalls TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB)…
- Polymer/Metal/Polymer Coated Porous Uncemented Semi-Constrained Patello/Femorotibial Knee Prosthesis
- Under Investigation by firm
Howmedica Osteonics Co…NJJun 24, 2026
Class IIOngoingZ-2461-2026
Howmedica Osteonics Corp. recalls TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB)…
- Polymer/Metal/Polymer Coated Porous Uncemented Semi-Constrained Patello/Femorotibial Knee Prosthesis
- Under Investigation by firm
Howmedica Osteonics Co…NJJun 24, 2026
Class IIOngoingZ-2460-2026
Accriva Diagnostics, Inc. recalls directCHECK ACT-LR whole blood quality control
Assayed Whole blood control contains labeling with incorrect performance range.
Accriva Diagnostics, I…CAJun 24, 2026
Class IIOngoingZ-2459-2026
AMD Medicom Inc. recalls Ritmed Neurological Sponges
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that co…
AMD Medicom Inc.Jun 24, 2026
Class IIOngoingZ-2458-2026
AMD Medicom Inc. recalls Ritmed Neurological Sponges
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that co…
AMD Medicom Inc.Jun 24, 2026
Class IOngoingZ-2457-2026
Abiomed, Inc. recalls Impella CP Set with SmartAssist. Product Codes: 1000080
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Abiomed, Inc.MAJun 24, 2026
Class IIOngoingZ-2456-2026
Smith & Nephew, Inc. recalls TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent na…
Smith & Nephew, Inc.TNJun 24, 2026
Class IIOngoingZ-2451-2026
Medtronic Navigation, Inc.-Boxborough recalls Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Medtronic Navigation,…MAJun 24, 2026
Class IIOngoingZ-2450-2026
Steris Corporation recalls ALYON Surgical Lighting System
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Steris CorporationOHJun 24, 2026
Class IIOngoingZ-2449-2026
Steris Corporation recalls HarmonyAIR A-Series Surgical Lighting System
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Steris CorporationOHJun 24, 2026