Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-04-09FDA-DeviceReichert, Inc.Class IIPhoroptor VRx Digital Refraction System Model Numbers: 16241
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
- 2025-04-09FDA-DeviceDraeger, Inc.Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceDraeger, Inc.Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceDraeger, Inc.Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceDraeger, Inc.Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceDraeger, Inc.Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceDraeger, Inc.Class IBrand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceDraeger, Inc.Class IBrand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceTerumo Cardiovascular Systems CorporationClass IITerumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
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.
- 2025-04-09FDA-DeviceStryker SpineClass IIMonterey AL Implant Inserter; 22mm; Catalog 48019140.
Potential for the gold unlock button to separate from the inserter.
- 2025-04-09FDA-DeviceStryker SpineClass IIMonterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Potential for the gold unlock button to separate from the inserter.
- 2025-04-09FDA-DeviceStryker SpineClass IIMonterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Potential for the gold unlock button to separate from the inserter.
- 2025-04-09FDA-DeviceStryker SpineClass IIMonterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Potential for the gold unlock button to separate from the inserter.
- 2025-04-09FDA-DeviceGE HealthcareClass IIGE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.
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.
- 2025-04-09FDA-DeviceGE HealthcareClass IIGE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
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.
- 2025-04-09FDA-DeviceGE HealthcareClass IIGE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.
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.
- 2025-04-09FDA-DeviceGE HealthcareClass IIGE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.
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.
- 2025-04-09FDA-DeviceGE HealthcareClass IIGE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-115; 10) 2088026-132; 11) 2088026-306; 12) 2088026-308; 13) 2088026-406; 14) 2088026-506; 15) 2088026-614; 16) 2088026-713; 17) 2088026-714; 18) 2088026-715; 19) 2088026-723; 20) 2088026-806; 21) 2088026-906; 22) 2088026-936; 23) 2088026-940; 24) 20880
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IIHemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IINasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IINasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IINasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IINasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IIHemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IINasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IIOtopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IINasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IINasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IIOtopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
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.
- 2025-04-09FDA-DeviceStryker CorporationClass IINasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
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.
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