Class IIOngoingZ-3191-2026
Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control.…
Datex-Ohmeda, Inc.WISep 23, 2026
Recalls: Nonconforming Material/Component
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 325 recalls
Class IIOngoingZ-3190-2026
Datex-Ohmeda, Inc. recalls Aisys CS2
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control.…
Datex-Ohmeda, Inc.WISep 23, 2026
Class IIOngoingZ-3189-2026
Datex-Ohmeda, Inc. recalls Aisys
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control.…
Datex-Ohmeda, Inc.WISep 23, 2026
Class IIOngoingZ-3188-2026
Boston Scientific Corporation recalls Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord
A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path.…
Boston Scientific Corp…MASep 23, 2026
Class IIOngoingZ-3180-2026
Embecta Medical II LLC recalls EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Dem…
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
embecta Medical II LLCNJSep 23, 2026
Class IIOngoingZ-3179-2026
Embecta Medical II LLC recalls EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated…
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
embecta Medical II LLCNJSep 23, 2026
Class IOngoingZ-3154-2026
AVID Medical, Inc. recalls Haylard UNIV IMAGING BIOPSY TRUCUSTOM
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
AVID Medical, Inc.VASep 23, 2026
Class IOngoingZ-3153-2026
AVID Medical, Inc. recalls Haylard BASIC BIOPSY TRAY
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
AVID Medical, Inc.VASep 23, 2026
Class IOngoingZ-3152-2026
AVID Medical, Inc. recalls Haylard CONTINUOUS NERVE BLOCK TRAY
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
AVID Medical, Inc.VASep 23, 2026
Class IOngoingZ-3151-2026
AVID Medical, Inc. recalls Haylard 18G SINGLE SHOT EPI TRAY
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
AVID Medical, Inc.VASep 23, 2026
Class IOngoingZ-3127-2026
Medline Industries, LP recalls Medline Convenience Kits: 1) DYNDB3086D
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides.…
Medline Industries, LPILSep 23, 2026
Class IOngoingZ-3126-2026
Medline Industries, LP recalls Medline Convenience Kits: 1) DYNDH1193
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides.…
Medline Industries, LPILSep 23, 2026