Medical DeviceApr 9, 2025
Anesthesia Circuit Kit Flex EPA recall — FDA Z-1499-2025
The potential for cracks forming in the breathing circuit hose.
Class IFDA: OngoingDraeger, Inc.
April 2025 recalls — page 9
These records include useful source details for the selected month.
Medical DeviceApr 9, 2025
BD SWITZERLAND SARL BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 recall — FDA Z-1509-2025
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
Class IIFDA: OngoingBD SWITZERLAND SARL
Medical DeviceApr 9, 2025
QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a recall — FDA Z-1504-2025
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Class IIFDA: OngoingQiagen Sciences LLC
Medical DeviceApr 9, 2025
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001 recall — FDA Z-1486-2025
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000)…
Class IIFDA: OngoingGE Healthcare
Medical DeviceApr 9, 2025
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number recall — FDA Z-1492-2025
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…
Class IIFDA: OngoingTerumo Cardiovascular Systems Corporation
Medical DeviceApr 9, 2025
Fisher Diagnostics Pacific Hemostasis Thromboplastin-D, 10 ml recall — FDA Z-1503-2025
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Class IIFDA: OngoingFisher Diagnostics
Medical DeviceApr 9, 2025
Stryker Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte recall — FDA Z-1474-2025
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…
Class IIFDA: OngoingStryker Corporation
Medical DeviceApr 9, 2025
Stryker Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and recall — FDA Z-1479-2025
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…
Class IIFDA: OngoingStryker Corporation
Medical DeviceApr 9, 2025
GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001 recall — FDA Z-1484-2025
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000)…
Class IIFDA: OngoingGE Healthcare
Medical DeviceApr 9, 2025
Stryker Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and recall — FDA Z-1478-2025
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…
Class IIFDA: OngoingStryker Corporation
Medical DeviceApr 9, 2025
PYRAMES Boppli: Bedside Device Kit, REF: 54-0002 recall — FDA Z-1508-2025
Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification.…
Class IIFDA: OngoingPYRAMES Inc.
Medical DeviceApr 9, 2025
Reichert Phoroptor VRx Digital Refraction System Model Numbers: 16242 recall — FDA Z-1501-2025
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Class IIFDA: OngoingReichert, Inc.
Medical DeviceApr 9, 2025
Stryker Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and recall — FDA Z-1470-2025
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…
Class IIFDA: OngoingStryker Corporation
Medical DeviceApr 9, 2025
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001 recall — FDA Z-1485-2025
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000)…
Class IIFDA: OngoingGE Healthcare
Medical DeviceApr 9, 2025
Stryker Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte recall — FDA Z-1473-2025
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…
Class IIFDA: OngoingStryker Corporation
Medical DeviceApr 9, 2025
Stryker Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S recall — FDA Z-1481-2025
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…
Class IIFDA: OngoingStryker Corporation
Medical DeviceApr 9, 2025
Anesthesia Circuit Kit Flex 1 recall — FDA Z-1495-2025
The potential for cracks forming in the breathing circuit hose.
Class IFDA: OngoingDraeger, Inc.
Medical DeviceApr 9, 2025
Ethicon Endo Surgery PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM recall — FDA Z-1515-2025
Identified curing issues with the silicone during the needles manufacturing process.
Class IIFDA: OngoingEthicon Endo Surgery, LLC
Medical DeviceApr 9, 2025
Ethicon Endo Surgery PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP recall — FDA Z-1513-2025
Identified curing issues with the silicone during the needles manufacturing process.
Class IIFDA: OngoingEthicon Endo Surgery, LLC
Medical DeviceApr 9, 2025
Cordis US Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F recall — FDA Z-1510-2025
product mix-up; Vascular stent labeled as one size but contains a different size.
Class IIFDA: OngoingCordis US Corp
Medical DeviceApr 9, 2025
Stryker Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and recall — FDA Z-1471-2025
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…
Class IIFDA: OngoingStryker Corporation
Medical DeviceApr 9, 2025
Reichert Phoroptor VRx Digital Refraction System Model Numbers: 16241 recall — FDA Z-1500-2025
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Class IIFDA: OngoingReichert, Inc.
Medical DeviceApr 9, 2025
Stryker Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S recall — FDA Z-1482-2025
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…
Class IIFDA: OngoingStryker Corporation
Medical DeviceApr 9, 2025
VentStar Flex 220 recall — FDA Z-1493-2025
The potential for cracks forming in the breathing circuit hose.
Class IFDA: OngoingDraeger, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.