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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.