Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 31, 2017 | 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-W... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿,... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Sto... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 24, 2017 | Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implan... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implant... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implanta... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implant... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillator... | Class II | Sorin Group Italia SRL - CRF |
| Jul 17, 2017 | CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 17, 2017 | CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle ... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 17, 2017 | CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 13, 2017 | Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumin... | Stylette removal difficulties on the Euphora and Solarice products. | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Jul 13, 2017 | Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumi... | Stylette removal difficulties on the Euphora and Solarice products. | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Jul 13, 2017 | Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W2... | The firm received several customer complaints reporting some perioperative breakages of NE0411 No... | Class II | In2Bones, SAS |
| Jul 12, 2017 | MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 ... | Affected units may have a defective component that is intended to protect the internal circuitry ... | Class I | Philips North America, LLC |
| Jul 5, 2017 | SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold... | Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manu... | Class II | Centurion Medical Products Corporation |
| Jun 29, 2017 | EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 29, 2017 | EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrill... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 29, 2017 | SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is inten... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 26, 2017 | Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Anal... | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... | Class II | Beckman Coulter Inc. |
| Jun 20, 2017 | Intellicuff Standalone (PN 951001) Used to continuously measure and automa... | Issue related to the performance of the motor in recalled product. During use, motor may cease to... | Class II | Hamilton Medical, Inc. |
| Jun 15, 2017 | Plum 360 Infusion System | Potential for the Connectivity Engine Module of the affected unit to disengage from the main chas... | Class II | ICU Medical Inc |
| Jun 15, 2017 | Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES... | The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1... | Class II | Custom Assemblies Inc |
| Jun 6, 2017 | Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Ve... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| May 30, 2017 | Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, N... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, ... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 N... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manif... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotat... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Co... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Con... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, It... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-C... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Ite... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usag... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Prod... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filt... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-r... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressu... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
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.