Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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 5, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall ProScreen CLIA Waived Cup 6 Drugs w/Adul Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen CLIA Waived Cup with 6 Drugs Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen CLIA Waived Cup with 8 Drug Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen CLIA Wvd 12 Panel Cup w/Adult. Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen Cup CLIA with 6 Panel Drug Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall RealityCHECK Tilt Cup 12 Panel + Adult Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall THERMO FISHER 6 DRUG CASSETTE Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall THERMO FISHER 8 DRUG CASSETTE Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cardinal Health Tiny Toes Heel warmers may cause first and second degree burns. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportMissourithe one state its words name PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Brilliance 64 Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance iCT Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance iCT SP Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenuity Core Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenuity Core 128 Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenuity CT Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo Imaging XS is a Picture Archiving and Communication System (PACS) For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming… Class IIFDA’s classDec 30, 2015in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin
- Medical device recall Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield). Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700. Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. Class IIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perseus A500 Anesthesia Workstation, MK06000 There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 23, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 23, 2015ClassClass IStatusTerminatedWhereIllinois, Maine, New York, Ohio, Pennsylvania and Wisconsin
- Medical device recall OmniPod¿, Insulin Management System (US) Pod’s needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall OmniPod¿, Insulin Management System (OUS) Pod’s needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Brilliance 64 Computed Tomography X-ray system During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Ingenuity Core Computed Tomography X-ray system During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Ingenuity CT Computed Tomography X-ray system During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline,… An incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients… GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, South Carolina, Tennessee, Texas and Washington named
- Medical device recall GE Healthcare Optima IGS 320 GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, South Carolina, Tennessee, Texas and Washington named
- Medical device recall Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and… Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereMinnesota
- Medical device recall VentriClear¿ II Ventricular Drainage Catheter Set Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereFlorida, Michigan, Pennsylvania and Tennessee
- Medical device recall Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire… The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania and South Carolina named
- Medical device recall Fujifilm Medical Systems Duodenoscope A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Iowa, Illinois, Kansas, Louisiana, Maryland, Minnesota, Missouri, North Carolina, Tennessee and Washington
- Medical device recall Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit… Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement Report20 statesnamed in where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall GlideScope Video Laryngoscope (GVL) Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GlideScope AVL Video Laryngoscope (AVL) Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0… MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0… MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0… MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0… MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0… MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application ( Middleware ) based on Web… MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application ( Middleware ) based on Web… MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0 Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0 Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0 Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10,… Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because the product does… Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall MiniMed 620G, 3.0mL mg/dL The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Class IIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 23, 2015ClassClass IIStatusTerminatedWhereNo state named
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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