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 ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used with Anspach Systems The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This device is intended… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only*** This device is… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is intended to be used with… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device is intended to be used… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This device is intended to be… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This device is intended to… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended to be used with… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY Surface finish is different than specified. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Siemens Dimension LOCI TNI Troponin I Calibrator RC 621 Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems because the bottle labeled as Calibrator… Class IIIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall MAS Omni Immune Controls The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change. Class IIIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall MAS Omni Immune PRO Controls The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change. Class IIIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Synergy XVI Intended for radiation therapy treatment. XVI can incorrectly calculate the target position of the treatment table. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereArizona, Connecticut, Iowa, Maryland, Michigan, Minnesota, Nevada, Ohio, Texas and Virginia
- Medical device recall Convatec Flexi Seal Control Fecal Management System Convatec Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Tytin Regular Set, Double Spill, 50 Capsules Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the… Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips/Children’s Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor. The battery pack wire harness is improperly assembled rendering the device inoperable. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereArizona, Florida, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Nevada, South Carolina, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator’s Manual Software Version 08-02 Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system… Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas 6000 analyzer series Operators Manual Roche cobas Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system… Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system… Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall APTIMA Urine Collection Kit Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. Class IIIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall IntellaTip MiFi XP Temperature Ablation Catheter Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IntellaTip MiFi XP Temperature Ablation Catheter Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IntellaTip MiFi XP Temperature Ablation Catheter Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IntellaTip MiFi XP Temperature Ablation Catheter Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IntellaTip MiFi XP Temperature Ablation Catheter Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass 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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