Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum. Product is not performing according to specifications. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report11 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Minnesota, North Carolina, Nevada, New York, Oregon, Puerto Rico, Tennessee and Texas
- Medical device recall RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic… MAKO has identified the potential that the shell impactors may be damaged intraoperatively. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by… MAKO has identified the potential that the shell impactors may be damaged intraoperatively. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by… MAKO has identified the potential that the shell impactors may be damaged intraoperatively. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete… Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Puritan Bennett 980 Ventilator Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedDec 17, 2014ClassClass IStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Wisconsin named
- Medical device recall BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with… It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Texas, Vermont, Washington and Wisconsin named
- Medical device recall Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and West Virginia named
- Medical device recall TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3) Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the… Laser etching on the parts is wider and deeper than the conditions previously validated. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota and Pennsylvania
- Medical device recall Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic… It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Florida, New York and West Virginia named
- Medical device recall Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Distal Access Catheter Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report17 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Illinois, Kentucky, Massachusetts, Michigan, Mississippi, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Trevo Pro 4 Stent Retriever Product shipped to US customers had non U.S. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Indiana, New Jersey and Pennsylvania
- Medical device recall Soft Contact Lens Portions of the lots may contain units with an incorrect lens axis condition. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A… AMO has received complaints where the finger grip dislodged while depressing the syringe plunger. Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use,… Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medical device recall A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall An endometrial suction curette is a device used to remove material from the uterus and from the mucosal… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall An external vein stripper is an extravascular device used to remove a section of a vein The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Manual trephines are bone cutting and drilling instruments that are used without a power source on a… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient’s… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient’s… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient’s… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall D’errico perforator drills are bone cutting and drilling instruments that are used without a power source on… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are… The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and… Class IIFDA’s classDec 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 17, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia 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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