Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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DateProductReasonClassFirm
Feb 15, 2018 SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of th... To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2018 SOMATOM Perspective 16 Intended to produce cross-sections images of the bo... to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2018 SOMATOM Emotion 16 Intended to produce cross-sections images of the body b... to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2018 SOMATOM Scope Power Intended to produce cross-sections images of the body ... to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2018 The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energ... Lasers/Catheters did not calibrate during set-up prior to use. Class II Ra Medical Systems Inc
Feb 15, 2018 SOMATOM Sensation Cardiac Intended to produce cross-sections images of the... to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2018 SOMATOM Sensation 40 Intended to produce cross-sections images of the body... to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2018 Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lac... Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular device... Class II Teleflex Medical
Feb 15, 2018 SOMATOM Perspective Intended to produce cross-sections images of the body... to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2018 SOMATOM Emotion (2003) Intended to produce cross-sections images of the bo... to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2018 SOMATOM Sensation 64 Intended to produce cross-sections images of the body... to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2018 Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT101... The sterility of the device cannot be assured. There is a potential for an increased risk of infe... Class II Transonic Systems Inc
Feb 15, 2018 SOMATOM Scope Intended to produce cross-sections images of the body by com... to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2018 SOMATOM Sensation Open Intended to produce cross-sections images of the bo... to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2018 SOMATOM Spirit Intended to produce cross-sections images of the body by co... to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... Class II Siemens Medical Solutions USA, Inc
Feb 14, 2018 ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product U... Control Console software has been updated to reduce the risk for collision when delivering automa... Class II Siemens Medical Solutions USA, Inc
Feb 14, 2018 ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product ... Control Console software has been updated to reduce the risk for collision when delivering automa... Class II Siemens Medical Solutions USA, Inc
Feb 14, 2018 ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Prod... Control Console software has been updated to reduce the risk for collision when delivering automa... Class II Siemens Medical Solutions USA, Inc
Feb 14, 2018 ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product ... Control Console software has been updated to reduce the risk for collision when delivering automa... Class II Siemens Medical Solutions USA, Inc
Feb 14, 2018 MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 019400... Control Console software has been updated to reduce the risk for collision when delivering automa... Class II Siemens Medical Solutions USA, Inc
Feb 14, 2018 ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an... The usage of workflows that deviate from the recommended specifications in the User manual for Ex... Class II Brainlab AG
Feb 14, 2018 PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: ... Control Console software has been updated to reduce the risk for collision when delivering automa... Class II Siemens Medical Solutions USA, Inc
Feb 13, 2018 ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239 Falsely elevated progesterone assay values will occur when using certain progesterone assay part ... Class II Tosoh Bioscience Inc
Feb 13, 2018 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Au... Module may freeze without generating user warning. There is a potential risk in delay of sample p... Class II Inpeco S.A.
Feb 13, 2018 BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Ca... Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube Class II Becton Dickinson & Company
Feb 13, 2018 RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (... All patient serum samples yield a weakly positive test result. Class II Stanbio Laboratory, LP
Feb 13, 2018 Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Produ... A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob wil... Class III Michigan Instruments, Inc.
Feb 13, 2018 ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240 Falsely elevated progesterone assay values will occur when using certain progesterone assay part ... Class II Tosoh Bioscience Inc
Feb 13, 2018 BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, C... Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube Class II Becton Dickinson & Company
Feb 13, 2018 Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 049... The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-ri... Class II Pentax of America Inc
Feb 12, 2018 Capio RP; Model #M0068321010. Intended for use in general suturing applica... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-5... The concentration of bromocresol purple in the recalled lots does not conform to specification. Class II Mesa Laboratories Bozeman Manufacturing Facility
Feb 12, 2018 Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use i... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in g... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue rei... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinfo... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 SporAmpule Biological Indicator Catalog Number SPS5-100 The concentration of bromocresol purple in the recalled lots does not conform to specification. Class II Mesa Laboratories Bozeman Manufacturing Facility
Feb 12, 2018 Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is ... The spreader bar can detach from the scale attachment under certain conditions. Class II Arjohuntleigh Magog
Feb 12, 2018 Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue re... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue rei... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Capio CL; Model #M0068311350. Indicated for the placement of suture in a v... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tiss... Class II Boston Scientific Corporation
Feb 12, 2018 Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is inte... The spreader bar can detach from the scale attachment under certain conditions. Class II Arjohuntleigh Magog
Feb 12, 2018 Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use ... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturin... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 8, 2018 Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray ... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Prod... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Cathe... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-... Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage... Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and... Class II Medtronic Perfusion Systems

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.