Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

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Date	Product	Reason	Class	Firm
Aug 30, 2019	Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used w...	The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were...	Class II	Philips Ultrasound Inc
Aug 30, 2019	Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide c...	The firm received reports of loss of audio alarm after a power failure or cable disconnection. Th...	Class II	Spacelabs Healthcare, Inc.
Aug 30, 2019	Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used w...	The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were...	Class II	Philips Ultrasound Inc
Aug 30, 2019	Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used a...	The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were...	Class II	Philips Ultrasound Inc
Aug 29, 2019	Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android sof...	The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging...	Class II	LABSTYLE INNOVATIONS
Aug 28, 2019	NavLock Tracker *** Rx Only	Product was incorrectly assembled which could affect navigation accuracy of the device.	Class II	Medtronic Navigation, Inc.
Aug 28, 2019	1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429	The product do not meet certain internal testing specifications.	Class II	Ethicon, Inc.
Aug 28, 2019	1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402	The product do not meet certain internal testing specifications.	Class II	Ethicon, Inc.
Aug 28, 2019	cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF i...	Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Int...	Class II	Roche Diagnostics Operations, Inc.
Aug 28, 2019	Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to ...	A mismatch between the angle of the hole in the base and the angle of the bell, which may cause ...	Class II	Centurion Medical Products Corporation
Aug 28, 2019	cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay...	Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Int...	Class II	Roche Diagnostics Operations, Inc.
Aug 28, 2019	1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201	The product do not meet certain internal testing specifications.	Class II	Ethicon, Inc.
Aug 28, 2019	Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to c...	A mismatch between the angle of the hole in the base and the angle of the bell, which may cause ...	Class II	Centurion Medical Products Corporation
Aug 28, 2019	NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); R...	The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implan...	Class II	Nobel Biocare Usa Llc
Aug 27, 2019	Karl Storz, Model # 11161C2, Flexible Neuroscope	During a complaint investigation it was determined that an error was observed within the instruc...	Class II	Karl Storz Endoscopy
Aug 27, 2019	Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1	During a complaint investigation it was determined that an error was observed within the instruc...	Class II	Karl Storz Endoscopy
Aug 27, 2019	AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-9...	The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potent...	Class II	Ad-Tech Medical Instrument Corporation
Aug 27, 2019	Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: ...	There is a potential patient health risk while performing chronic hemodialysis treatments in the ...	Class II	NxStage Medical, Inc.
Aug 27, 2019	Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope	During a complaint investigation it was determined that an error was observed within the instruc...	Class II	Karl Storz Endoscopy
Aug 26, 2019	Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, w...	Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with th...	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Aug 26, 2019	Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-...	The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used...	Class II	LivaNova Deutschland GmbH
Aug 26, 2019	Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15,...	The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used...	Class II	LivaNova Deutschland GmbH
Aug 23, 2019	Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excime...	At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer la...	Class II	Ra Medical Systems, Inc.
Aug 23, 2019	Monaco Radiation Treatment Planning System (RTP) System	Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setu...	Class II	Elekta, Inc.
Aug 23, 2019	IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affecte...	Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some I...	Class II	Philips North America, LLC
Aug 22, 2019	CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS M...	Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting ...	Class I	Thoratec Switzerland GMBH
Aug 22, 2019	The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double ...	Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) H...	Class II	GETINGE US SALES LLC
Aug 22, 2019	iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient...	Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.	Class II	Conformis, Inc.
Aug 22, 2019	iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient...	Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.	Class II	Conformis, Inc.
Aug 22, 2019	VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal ne...	Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-en...	Class I	LivaNova USA Inc
Aug 22, 2019	Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)050559827...	The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (brea...	Class II	ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Aug 21, 2019	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.	Reports received of the device fracturing during insertion.	Class II	CTL Medical Corporation
Aug 21, 2019	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.	Reports received of the device fracturing during insertion.	Class II	CTL Medical Corporation
Aug 21, 2019	GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usa...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthop...	Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the...	Class II	Zimmer GmbH
Aug 21, 2019	Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Pro...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instru...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 ...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 17...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 ...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large...	Possible suture brittleness or breakage along the Envelope seam before the expiration date of the...	Class II	AZIYO BIOLOGICS
Aug 21, 2019	LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMR...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arco...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	Comprehensive RS Cleat CAP, Item No. 110300	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a...	Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)...	Class II	Boston Scientific Corporation
Aug 21, 2019	HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin ...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.	Reports received of the device fracturing during insertion.	Class II	CTL Medical Corporation
Aug 21, 2019	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEn...	Possible suture brittleness or breakage along the Envelope seam before the expiration date of the...	Class II	AZIYO BIOLOGICS

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.