April 9, 2025Medical DevicesFDA
Reichert, Inc. recalls Phoroptor VRx Digital Refraction System Model Numbers: 16241
Hazard: The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
April 9, 2025Medical DevicesFDA
Draeger, Inc. recalls Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Softwa
Hazard: The potential for cracks forming in the breathing circuit hose.
April 9, 2025Medical DevicesFDA
Draeger, Inc. recalls Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Softw
Hazard: The potential for cracks forming in the breathing circuit hose.
April 9, 2025Medical DevicesFDA
Draeger, Inc. recalls Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software
Hazard: The potential for cracks forming in the breathing circuit hose.
April 9, 2025Medical DevicesFDA
Draeger, Inc. recalls Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software
Hazard: The potential for cracks forming in the breathing circuit hose.
April 9, 2025Medical DevicesFDA
Draeger, Inc. recalls Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software
Hazard: The potential for cracks forming in the breathing circuit hose.
April 9, 2025Medical DevicesFDA
Draeger, Inc. recalls Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicab
Hazard: The potential for cracks forming in the breathing circuit hose.
April 9, 2025Medical DevicesFDA
Draeger, Inc. recalls Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable
Hazard: The potential for cracks forming in the breathing circuit hose.
April 9, 2025Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Hazard: During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
April 9, 2025Medical DevicesFDA
Stryker Spine recalls Monterey AL Implant Inserter; 22mm; Catalog 48019140.
Hazard: Potential for the gold unlock button to separate from the inserter.
April 9, 2025Medical DevicesFDA
Stryker Spine recalls Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Hazard: Potential for the gold unlock button to separate from the inserter.
April 9, 2025Medical DevicesFDA
Stryker Spine recalls Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Hazard: Potential for the gold unlock button to separate from the inserter.
April 9, 2025Medical DevicesFDA
Stryker Spine recalls Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Hazard: Potential for the gold unlock button to separate from the inserter.
April 9, 2025Medical DevicesFDA
GE Healthcare recalls GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086;
Hazard: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
April 9, 2025Medical DevicesFDA
GE Healthcare recalls GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-00
Hazard: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
April 9, 2025Medical DevicesFDA
GE Healthcare recalls GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001;
Hazard: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
April 9, 2025Medical DevicesFDA
GE Healthcare recalls GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2
Hazard: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
April 9, 2025Medical DevicesFDA
GE Healthcare recalls GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4)
Hazard: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Nu
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Nu
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
April 9, 2025Medical DevicesFDA
Stryker Corporation recalls Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Hazard: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.