Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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Date	Product	Reason	Class	Firm
Oct 19, 2016	ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur an...	CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the A...	Class II	Siemens Healthcare Diagnostics, 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 19, 2016	Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit includin...	Products are not designed, qualified, manufactured, and/or managed under a state of control per i...	Class II	Ultroid Technologies, Inc.
Oct 18, 2016	ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Ca...	Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.	Class II	ConforMIS, Inc.
Oct 18, 2016	Xhibit Central Station, Model 96102. Intended use is to provide clinicia...	The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. De...	Class II	Spacelabs Healthcare Inc
Oct 18, 2016	Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed ...	Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units l...	Class II	Teleflex Medical
Oct 17, 2016	Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Sk...	Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table heig...	Class II	Siemens Medical Solutions USA, Inc
Oct 15, 2016	Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette ...	The fuse blows during initial power up or after a period of time. This results in a complete los...	Class II	Natus Manufacturing Limited
Oct 14, 2016	Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, ...	Sterility of the outer surface of the container compromised due to packaging defect.	Class II	Covidien LLC
Oct 14, 2016	ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog...	ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak o...	Class II	Reshape Medical Inc
Oct 14, 2016	Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL	Due to customer-experienced complaints on narrow assay range compared to prior lots and the user ...	Class II	Helena Laboratories, Inc.
Oct 14, 2016	OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigati...	Incorrect lot number on outer kit	Class III	OMNI LIFE SCIENCE
Oct 13, 2016	Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral...	Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside...	Class II	C.R. Bard, Inc.
Oct 13, 2016	Ingenuity CT Computed Tomography X-ray system, Model 728326	The product label does not include the correct current rating.	Class III	Philips Medical Systems (Cleveland) Inc
Oct 13, 2016	Ingenuity Core 128 Computed Tomography X-ray system, Model 728323	The product label does not include the correct current rating.	Class III	Philips Medical Systems (Cleveland) Inc
Oct 13, 2016	Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coi...	Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside...	Class II	C.R. Bard, Inc.
Oct 13, 2016	IQon Spectral CT Computed Tomography X-ray system, Model 728332	The product label does not include the correct current rating.	Class III	Philips Medical Systems (Cleveland) Inc
Oct 13, 2016	Brilliance ICT SP Computed Tomography X-ray system, Model 728311	The product label does not include the correct current rating.	Class III	Philips Medical Systems (Cleveland) Inc
Oct 13, 2016	Ingenuity Core Computed Tomography X-ray system, Model 728321	The product label does not include the correct current rating.	Class III	Philips Medical Systems (Cleveland) Inc
Oct 13, 2016	PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677....	Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for...	Class II	PerkinElmer, Inc
Oct 13, 2016	BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covingt...	Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside...	Class II	C.R. Bard, Inc.
Oct 13, 2016	Brilliance iCT Computed Tomography X-ray system, Model 728306	The product label does not include the correct current rating.	Class III	Philips Medical Systems (Cleveland) Inc
Oct 13, 2016	Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Co...	Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside...	Class II	C.R. Bard, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCR...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW ...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCRE...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SC...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-12...	A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.	Class II	CYPRESS MEDICAL PRODUCTS
Oct 12, 2016	X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE...	Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.	Class II	C.R. Bard, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCRE...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the p...	Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Val...	Class II	Alere San Diego, Inc.
Oct 12, 2016	C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Steri...	Defect; The contact part could possibly separate from the electrode affecting to functionality of...	Class II	C.R. Bard, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING ...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic ...	According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his sup...	Class II	Bausch & Lomb, Inc.
Oct 12, 2016	DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCR...	SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.	Class II	DePuy Spine, Inc.
Oct 12, 2016	GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 1...	Potential presence of particulate matter on the blood side of the dialyzer	Class II	Baxter Healthcare Corp.
Oct 11, 2016	NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers...	The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit d...	Class II	Baylis Medical Corp *
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 11, 2016	RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U	Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged ...	Class III	Stryker Instruments Div. of Stryker Corporation
Oct 11, 2016	ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for t...	Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHIT...	Class II	Abbott Laboratories
Oct 11, 2016	Radiation Therapy Treatment Planning System Product Usage: RayStation is...	An error may occur with the display of dose computed on images other than the planning CT (auxili...	Class II	RAYSEARCH LABORATORIES AB
Oct 11, 2016	ROSA Brain, 3.0.0 The device is intended for the spatial positioning and ori...	Complaint of the head holder connector locking up mechanically when tightened.	Class II	Zimmer Biomet, Inc.
Oct 10, 2016	Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241...	St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio...	Class I	St Jude Medical Inc.
Oct 10, 2016	Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quad...	St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio...	Class I	St Jude Medical Inc.
Oct 10, 2016	Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, C...	St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio...	Class I	St Jude Medical Inc.
Oct 7, 2016	Advia Chemistry Calibrator For in vitro diagnostic use in the calibration o...	Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the ...	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 6, 2016	Autolube-III Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, Inc.
Oct 6, 2016	AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system	Supplied Directions for Use (DFU) did not contain a recommended service interval.	Class II	The Anspach Effort, 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.