Class IIOngoingZ-2968-2026
Gentherm Medical, LLC recalls Blanketrol II Model 222S
Overheating of the 115V CPU board may cause the device to shut down.
Gentherm Medical, LLCOHAug 26, 2026
Recalls: Device Design
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 218 recalls
Class IIOngoingZ-2960-2026
Tobii Dynavox LLC recalls TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit.…
Tobii Dynavox LlcPAAug 26, 2026
Class IIOngoingZ-2959-2026
Tobii Dynavox LLC recalls TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit.…
Tobii Dynavox LlcPAAug 26, 2026
Class IIOngoingZ-2957-2026
Kico Knee Innovation Company recalls Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2…
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
Kico Knee Innovation C…Aug 26, 2026
Class IIOngoingZ-2954-2026
SDI Limited recalls Dentsply Sirona Capsule Mixer Model No. 5546068
Potential for electrical discharge from unit when unplugged.
SDI LimitedAug 26, 2026
Class IIOngoingZ-2938-2026
Erbe USA Inc recalls ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive press…
Erbe USA IncGAAug 19, 2026
Class IIOngoingZ-2898-2026
United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral offset bushing
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
United Orthopedic Corp…Aug 12, 2026
Class IIOngoingZ-2897-2026
United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral offset bushing
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
United Orthopedic Corp…Aug 12, 2026
Class IOngoingZ-2879-2026
Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, i…
Boston Scientific Neur…CAAug 12, 2026
Class IIOngoingZ-2833-2026
Stryker GmbH recalls Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Stryker GmbHAug 5, 2026
Class IIOngoingZ-2832-2026
Stryker GmbH recalls Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Stryker GmbHAug 5, 2026
Class IIOngoingZ-2831-2026
Stryker GmbH recalls Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Stryker GmbHAug 5, 2026