Browse Device Recalls
797 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 797 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 797 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 31, 2017 | LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrica... | A shipment of LCSU 4 suction units and canisters attempted importation into the United States but... | Class II | Laerdal Medical Corporation |
| Aug 28, 2017 | PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) dev... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker ... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (L... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devic... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Jul 17, 2017 | ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units... | Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from ... | Class II | Philips Electronics North America Corporation |
| Jun 16, 2017 | CS 100 Intra-Aortic Balloon Pump | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jun 16, 2017 | CS 100i Intra-Aortic Balloon Pump | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jun 16, 2017 | CS 300 Intra-Aortic Balloon Pump | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jun 7, 2017 | MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to ... | An intermittent electrical problem that could lead to a loss of system power due to a loose screw... | Class II | Mako Surgical Corporation |
| Jun 5, 2017 | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN)... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H78... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) ... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (U... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model ... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 2, 2017 | Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO ... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Pro... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO ... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Pro... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, P... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| Jun 2, 2017 | Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Pro... | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... | Class II | St. Jude Medical, Inc. |
| May 23, 2017 | Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic ir... | If the gantry module is replaced after original installation the configuration settings may be mi... | Class II | Elekta, Inc. |
| May 15, 2017 | FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is int... | The device history record (DHR) was missing its test documentation for final HIPOT (high potentia... | Class II | Boston Scientific Corporation |
| Apr 12, 2017 | Savaria SL-1000 Stairlift | The electrical controller, combined with motor, causes feedback, damaging a component on the cont... | Class II | Savaria Concord Lifts, Inc. |
| Mar 22, 2017 | UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNI... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... | Class II | Philips Electronics North America Corporation |
| Mar 22, 2017 | The following systems are only affected if a Laird chiller is installed (11NC... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... | Class II | Philips Electronics North America Corporation |
| Mar 22, 2017 | Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... | Class II | Philips Electronics North America Corporation |
| Mar 21, 2017 | Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular ... | Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and l... | Class II | Roche Diagnostics Corporation |
| Mar 10, 2017 | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Prod... | In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to th... | Class I | Heartware |
| Feb 27, 2017 | Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ON... | A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 ma... | Class II | Welch Allyn Inc |
| Oct 19, 2016 | SOMATOM Definition Flash system, x-ray, tomography, computed | Hardware issue that may expose the user to a potential risk for serious injury due to exposure to... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2016 | SOMATOM Definition AS system, x-ray, tomography, computed | Hardware issue that may expose the User to a potential risk for serious injury due to exposure to... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2016 | SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM ... | A problem can occur with the small light marker windows, used for the positioning laser and are i... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2016 | SOMATOM Definition Flash, Computed tomography system Product Usage: SOMAT... | A problem can occur with the small light marker windows, used for the positioning laser and are i... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 11, 2016 | Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Per... | Nuvectra is conducting a recall due to two clinical risks that are associated with certain percu... | Class II | Nuvectra |
| Oct 6, 2016 | Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophy... | The EP Catheters may be mislabeled for French size during reprocessing. | Class II | Stryker Sustainability Solutions |
| Sep 27, 2016 | SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C., Item No. 46097-30 The... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., ... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC., Item No. 460... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital, Item No. 46070-30 The Tr... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush D... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | Cath Lab Kit w/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringe... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac D... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59 The T... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 4259... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | Transpac¿ IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposab... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 460... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU 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.