Class IIOngoingZ-3175-2026
Happiest Baby, Inc recalls Happiest Baby
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Happiest Baby, IncCASep 23, 2026
Recalls: Device Design
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 218 recalls
Class IIOngoingZ-3165-2026
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System.
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
NOXBOX LTDSep 23, 2026
Class IOngoingZ-3080-2026
BD SWITZERLAND SARL recalls BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Inf…
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
BD SWITZERLAND SARLSep 23, 2026
Class IIOngoingZ-3110-2026
Lutronic Corporation recalls Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device…
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Lutronic CorporationSep 16, 2026
Class IIOngoingZ-3064-2026
Johnson & Johnson Surgical Vision, Inc. recalls HEALON EndoCoat PRO
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion…
Johnson & Johnson Surg…CASep 9, 2026
Class IIOngoingZ-3039-2026
GE Medical Systems Information Technologies Inc recalls FRU (Field replaceable unit)
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
GE Medical Systems Inf…WISep 2, 2026
Class IIOngoingZ-3038-2026
GE Medical Systems Information Technologies Inc recalls PORTRAIT CORE SERVICES SOFTWARE V1.0.5
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
GE Medical Systems Inf…WISep 2, 2026
Class IIOngoingZ-3037-2026
GE Medical Systems Information Technologies Inc recalls PORTRAIT COMPUTE AND CORE SERVICES V1.2
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
GE Medical Systems Inf…WISep 2, 2026
Class IIOngoingZ-3036-2026
GE Medical Systems Information Technologies Inc recalls PORTRAIT CORE SERVICES SOFTWARE V1.1
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
GE Medical Systems Inf…WISep 2, 2026
Class IIOngoingZ-2987-2026
Restor3d Inc. recalls Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Gle…
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
restor3d Inc.NCAug 26, 2026
Class IIOngoingZ-2970-2026
Gentherm Medical, LLC recalls Blanketrol III
Overheating of the 115V CPU board may cause the device to shut down.
Gentherm Medical, LLCOHAug 26, 2026
Class IIOngoingZ-2969-2026
Gentherm Medical, LLC recalls Innercool Coolblue Console
Overheating of the 115V CPU board may cause the device to shut down.
Gentherm Medical, LLCOHAug 26, 2026