Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Nasopore Ex Firm 4cm fragmentable nasal dressing There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nasopore Ex Firm 8cm fragmentable nasal dressing There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nasopore 4cm Standard 2PK fragmentable nasal dressing There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nasopore 4cm Standard 2PK fragmentable nasal dressing There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hemopore 2PK nasal/sinus temporary wound dressing There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GE Healthcare Centricity Universal Viewer (UV) There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity… Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Centricity PACS-IW (PACS-IW) There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity… Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Centricity Radiology RA600 (RA600) There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity… Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Centricity Cardiology CA1000 (CA1000) There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity… Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Centricity Centricity PACS-IW with Universal Viewer There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity… Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Monterey AL Implant Inserter Potential for the gold unlock button to separate from the inserter. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Hampshire, New York, Oklahoma, Pennsylvania, Texas and Utah
- Medical device recall Monterey AL Implant Inserter Potential for the gold unlock button to separate from the inserter. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Hampshire, New York, Oklahoma, Pennsylvania, Texas and Utah
- Medical device recall Monterey AL Implant Inserter Potential for the gold unlock button to separate from the inserter. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Hampshire, New York, Oklahoma, Pennsylvania, Texas and Utah
- Medical device recall Monterey AL Implant Inserter Potential for the gold unlock button to separate from the inserter. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Illinois, Massachusetts, Nebraska, New Hampshire, New York, Oklahoma, Pennsylvania, Texas and Utah
- Medical device recall Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereFlorida, Illinois, Michigan, Nevada, New York and Texas
- Medical device recall Brand Name: VentStar Product Name: VentStar Flex 220 The potential for cracks forming in the breathing circuit hose. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: ID Circuit Product Name: ID Circuit Flex 220 The potential for cracks forming in the breathing circuit hose. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 The potential for cracks forming in the breathing circuit hose. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 The potential for cracks forming in the breathing circuit hose. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 The potential for cracks forming in the breathing circuit hose. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 The potential for cracks forming in the breathing circuit hose. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA The potential for cracks forming in the breathing circuit hose. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Phoroptor VRx Digital Refraction System The head of the phoropter head could come loose and potentially detach due to a default in the assembly. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Phoroptor VRx Digital Refraction System The head of the phoropter head could come loose and potentially detach due to a default in the assembly. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pacific Hemostasis Thromboplastin-D, 4 ml The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 9, 2025ClassClass IIStatusOngoingWherePennsylvania
- Medical device recall Pacific Hemostasis Thromboplastin-D, 10 ml The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 9, 2025ClassClass IIStatusOngoingWherePennsylvania
- Medical device recall Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224… Identified faulty cartridges. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement Report12 statesnamed in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereAlabama, California, District of Columbia, Florida, Indiana, Kansas, Kentucky, Massachusetts, Maine, Minnesota, New York and Texas
- Medical device recall A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System. Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Boppli: Bedside Device Kit 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… Class IIFDA’s classApr 9, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereCalifornia and Massachusetts
- Medical device recall BD Connecta BD Luer-Lok 360 Due to specific lots of luer-lok devices were shipped to the U.S. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only product mix-up; Vascular stent labeled as one size but contains a different size. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, Florida, New Jersey and Tennessee
- Medical device recall Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only product mix-up; Vascular stent labeled as one size but contains a different size. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, Florida, New Jersey and Tennessee
- Medical device recall PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP Identified curing issues with the silicone during the needles manufacturing process. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1 Identified curing issues with the silicone during the needles manufacturing process. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM Identified curing issues with the silicone during the needles manufacturing process. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH Identified curing issues with the silicone during the needles manufacturing process. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxC 500 AU Clinical Chemistry Analyzer Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, Mississippi, Montana, North Carolina, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 2, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 2, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall CVAC Aspiration System Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 2, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Premier Solo Diamond - Large Invented Cone The hardness not meeting the material specification and may cause the diamond bur to bend. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Minnesota, New York, Pennsylvania, Tennessee, Virginia and Washington named
- Medical device recall Baxter Operating table column TS7500 MOBIUS There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Stationary column TruSystem 7500 There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Floor mounting column TruSystem 7500 There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Mobile column TruSystem 7500 There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Mobile column TruSystem 7500 U There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Stationary column TruSystem 7500 U There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Floor mounting column TS 7500 U There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter TruSystem 7500 Hybrid (MC) There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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