Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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 7, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Horizon 24 Large Titanium Clips with Adhesive Backing The manufacturing and expiration dates are not printed on the blister pack label. Class IIFDA’s classAug 10, 2016in FDA’s Enforcement Report20 statesnamed in where it went PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Illinois, Kentucky, Maryland, Michigan, Minnesota, North Carolina, New Mexico, New York, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals… If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to… Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 6F/7F MynxGrip Vascular Closure Device A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations. Class IIFDA’s classAug 10, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereCalifornia and Mississippi
- Medical device recall EnVision FLEX+, Mouse, High pH (Link), Product No The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1. Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Spirit Plus Bed, A-C Powered Hospital Bed Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered hospital beds due to reports of hi-lo actuators broken at the… Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Spirit Select Bed, A-C Powered Hospital Bed Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered hospital beds due to reports of hi-lo actuators broken at the… Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a… Labeling problem Class IIIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 10, 2016ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Illinois, Kentucky, Minnesota, North Carolina, Oregon, Rhode Island, South Dakota, Texas, Utah and Washington named
- Medical device recall Zimmer¿ Air Dermatome II Handpiece The surface coating applied to the device is blistering, peeling and discoloring after usage over time Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Zimmer¿ Air Dermatome II Handpiece w/o Hose The surface coating applied to the device is blistering, peeling and discoloring after usage over time Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Zimmer¿ Air Dermatome II Width Plate, 1 in. The surface coating applied to the device is blistering, peeling and discoloring after usage over time Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Zimmer¿ Air Dermatome II Width Plate, 2 inch The surface coating applied to the device is blistering, peeling and discoloring after usage over time Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Zimmer¿ Air Dermatome II Width Plate, 1.5 inch The surface coating applied to the device is blistering, peeling and discoloring after usage over time Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Zimmer¿ Air Dermatome II Width Plate, 3 inch The surface coating applied to the device is blistering, peeling and discoloring after usage over time Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Zimmer¿ Air Dermatome II Width Plate, 4 inch The surface coating applied to the device is blistering, peeling and discoloring after usage over time Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Merge HEMO software. The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7 Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 91496 Ultraview SL Command Module, Options A, B, C, and I The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 3, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 3, 2016ClassClass IStatusTerminatedWhereMaryland and Washington
- Medical device recall GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereFlorida, Tennessee and Texas
- Medical device recall Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products… It was discovered that both the new device and the predicate device failed to comply with performance standard. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AUTOCOMP6 XPS High Speed Compounder An issue was identified after a redesign of the auto compounding device. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report21 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Washington
- Medical device recall AUTOCOMP6 XP High Speed Compounder An issue was identified after a redesign of the auto compounding device. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report21 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Washington
- Medical device recall AUTOCOMP6 High Speed Compounder An issue was identified after a redesign of the auto compounding device. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report21 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Washington
- Medical device recall Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL. An issue was identified after a redesign of the auto compounding device. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report21 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Washington
- Medical device recall Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000… An issue was identified after a redesign of the auto compounding device. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report21 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Washington
- Medical device recall Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL An issue was identified after a redesign of the auto compounding device. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report21 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Washington
- Medical device recall Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL /… An issue was identified after a redesign of the auto compounding device. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report21 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Washington
- Medical device recall Container fill and transfer sets, 250 mL and 500 mL, . . An issue was identified after a redesign of the auto compounding device. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement Report21 statesnamed in where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Washington
- Medical device recall Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma) The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. Class IIIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 3, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Cardinal Health Mono Rapid Test The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. Class IIIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 3, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Clearview MONO (Whole Blood, Serum, Plasma) The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. Class IIIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 3, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Henry Schein One Step + Mono Rapid Test Device The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. Class IIIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 3, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Proadvantage Mono Rapid Test Cassette The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. Class IIIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 3, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Stanbio Rely Mono Rapid Test The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. Class IIIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 3, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Signify Mono (Whole Blood, Serum, Plasma) The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. Class IIIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 3, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected… Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 3, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No.… Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Allegra X-5 rotor yoke A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower… Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the… Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the… Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper… Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization… Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower… Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package Instructions For Use had incorrect lot number and calibrator values Class IIIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 3, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Kentucky, Massachusetts, New York, Ohio, South Carolina, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Anastoclip AC 8cm 35 Clips US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AnastoClip AC 8cm 35 Clips US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are… Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
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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