Browse Device Recalls

780 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 780 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 780 FDA device recalls.

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Date	Product	Reason	Class	Firm
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.
Sep 27, 2016	Transpac¿ IV Monitoring Kit w/Safeset 84" Arterial Pressure Tubing, Reservoir...	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/Waste Bag System, 3 Port "OFF" Manifold (600 psi), Transpac¿ I...	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 WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, ...	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, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRO...	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/Safeset" Blood Sampling Port and 03 ml Squeeze ...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Sep 27, 2016	TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needlele...	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 INTRAFLO¿ FLUSH...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Sep 27, 2016	LEFT HEART KIT FOR PORTLAND ADVENTIST HOSP., Item No. 46066-13 The Transpac ...	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 BIFURCATED KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS,...	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 BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Sep 27, 2016	TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV. OF IOWA, Item No. 46091-56 ...	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/Arterial 84" Safeset" Reservoir, 03 ml Squeeze ...	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 WITH 03ML FLUSH DEVICE FOR CARLE CLINIC, Item No. 46087-37 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	TRANSPAC¿ IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH ...	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¿ w/Safeset Reservoir, Squeeze 03 ml Flush and Needleless Valve, Item...	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 DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06 The Tra...	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.