Browse Device Recalls

2,049 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,049 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 2,049 FDA device recalls in N/A.

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Date	Product	Reason	Class	Firm
Jun 24, 2020	PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1...	Reagents were shipped to customers after the Use by data indicated on its labeling.	Class III	DNA Genotek Inc.
Jun 23, 2020	TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses	Colored contact lenses were distributed without FDA clearance.	Class II	Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020	TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses	Colored contact lenses were distributed without FDA clearance.	Class II	Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020	TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact...	Colored contact lenses were distributed without FDA clearance.	Class II	Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020	TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses	Colored contact lenses were distributed without FDA clearance.	Class II	Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020	TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact le...	Colored contact lenses were distributed without FDA clearance.	Class II	Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020	Neurosign V4 Intraoperative Nerve monitor family of devices.	Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and...	Class II	The Magstim Company Limited
Jun 23, 2020	TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses	Colored contact lenses were distributed without FDA clearance.	Class II	Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020	TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses	Colored contact lenses were distributed without FDA clearance.	Class II	Chengdu Ai Qin E-commerce Co., Ltd
Jun 22, 2020	CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usa...	Software defect may result in disapperance of tag sites during recalculation and lead to addition...	Class II	Biosense Webster (israel), Ltd.
Jun 20, 2020	Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 0697157...	The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Jun 20, 2020	Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 0697157...	The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Jun 20, 2020	Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 0697157...	The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Jun 19, 2020	Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series ...	Quality Control results were not properly evaluated for QC failures.	Class II	Abbott Gmbh & Co. KG
Jun 17, 2020	LoFric Origo, Nelaton, 16in, FR10 urinary catheters	Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a ...	Class II	Wellspect HealthCare (Division of DENTSPLY IH AB)
Jun 17, 2020	LoFric Origo, Tiemann, 16in, FR14 urinary catheters	Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a ...	Class II	Wellspect HealthCare (Division of DENTSPLY IH AB)
Jun 17, 2020	LoFric Origo, Tiemann, 16in, FR12 urinary catheters	Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a ...	Class II	Wellspect HealthCare (Division of DENTSPLY IH AB)
Jun 17, 2020	DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA ...	The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman C...	Class II	Beckman Coulter Biomedical GmbH
Jun 16, 2020	MatrixMIDFACE Screws - Product Usage: The intended use for this device is in ...	One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a bo...	Class II	Synthes Produktions GmbH
Jun 10, 2020	Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887	The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may ...	Class II	Elekta Instrument AB
Jun 8, 2020	Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPr...	The motor controller may fail, which can potentially lead to an error in functionality of the Bod...	Class II	Hocoma AG
Jun 5, 2020	Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) com...	Tube material of a smaller diameter was used.	Class II	Richard Wolf GmbH
May 26, 2020	RayStation standalone software treatment planning system (RayStation 8A, 8B, ...	It is not obvious that the manual import of a treatment record into RayCare PACS does not automat...	Class II	RAYSEARCH LABORATORIES AB
May 26, 2020	ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPIN...	6.0x50mm poly-reduction screws were laser etched 6.0x45	Class II	U&I CORP.
May 23, 2020	Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 In...	Two issues were identified with the computed tomography x-ray system including a service function...	Class II	Shanghai United Imaging Healthcare Co., Ltd.
May 21, 2020	Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, ...	In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there ca...	Class II	Elekta Limited
May 18, 2020	RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radi...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Produ...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy a...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation ...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radi...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy an...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy an...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radi...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy a...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy a...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiat...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiat...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radi...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 18, 2020	RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radia...	Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu...	Class II	RAYSEARCH LABORATORIES AB
May 15, 2020	DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is...	Failures were found in the temperature measurement function while in the predict mode.	Class II	Mediana Co., Ltd.
May 12, 2020	Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for c...	Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)	Class I	Medtronic Vascular Galway DBA Medtronic Ireland
May 11, 2020	ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Pr...	Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, ...	Class II	Radiometer Medical ApS
May 11, 2020	ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 0570069393841...	Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, ...	Class II	Radiometer Medical ApS
May 8, 2020	uCT 530 Computed Tomography X-Ray System	Two issues were identified with the computed tomography x-ray system including a service function...	Class II	Shanghai United Imaging Healthcare Co., Ltd.
May 4, 2020	AC Powered hospital adjustable bed.	Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.	Class II	Umano Medical, Inc.
Apr 29, 2020	Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Cat...	Product was not irradiated; therefore, they are not sterile and do not meet product specification.	Class II	Thermo Fisher Scientific (Monterrey)
Apr 24, 2020	ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained ...	Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High...	Class II	Abbott Gmbh & Co. KG
Apr 21, 2020	Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus P...	Signature from the user is necessary to proceed with specific actions in the Proton Therapy Syste...	Class II	Ion Beam Applications S.A.

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.