Browse Device Recalls
1,361 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,361 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 1,361 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 17, 2015 | Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S Peoduc... | Probe programming error. The incorrect program can generate more heat at the surgical site, resu... | Class II | ConMed Corporation |
| May 13, 2015 | Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression t... | Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for... | Class II | Advanced Back Technologies, Inc. |
| May 13, 2015 | Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for tra... | Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for... | Class II | Advanced Back Technologies, Inc. |
| May 6, 2015 | enGen Laboratory Automation System (enGen System), Product Code ENGEN, config... | Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of ent... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2015 | IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (... | IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to s... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 9, 2015 | IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement... | IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parame... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 6, 2015 | VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-... | Software anomaly allows testing of multiple assays using a single urine specimen, regardless of t... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-... | Software anomaly allows testing of multiple assays using a single urine specimen, regardless of t... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | Assay Data Disk (ADD), All DRV versions that support product within expiry da... | Software anomaly regarding urine samples that require acidified pretreatment. The software has a... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre... | Software anomaly regarding urine samples that require acidified pretreatment. The software has a... | Class II | Ortho-Clinical Diagnostics |
| Apr 2, 2015 | MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma dete... | The probability and histogram data within the Melafind's device displayed user interface lacks ap... | Class II | MELA Sciences, Inc. |
| Mar 23, 2015 | ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894. | Siemens internal investigation confirmed that current contamination avoidance settings do not pre... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 10, 2015 | Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Numb... | Software Anomaly; It is possible for the device to process samples with a cartridge other than th... | Class II | Ortho-Clinical Diagnostics |
| Feb 17, 2015 | Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemod... | Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condit... | Class II | Transonic Systems Inc |
| Feb 11, 2015 | ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Versio... | Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 19, 2015 | ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the... | Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2015 | NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 6010... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 601... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog N... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965P... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog N... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 601... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No.... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 600... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 600... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 6... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H965PK193168S1, REF/Catalog No. PK193168S, STERILE... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602000571, REF/Catalog No. 602... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 601... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749601801561, REF/Catalog No. 60180156, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 600... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 601... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 600... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 601... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 60191101... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.