Browse Device Recalls
2,984 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,984 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 2,984 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 19, 2019 | Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgi... | The sterile barrier of some devices may have been affected | Class II | Xodus Medical Inc |
| Sep 19, 2019 | Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory | The sterile barrier of some devices may have been affected | Class II | Xodus Medical Inc |
| Sep 19, 2019 | Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical a... | The sterile barrier of some devices may have been affected | Class II | Xodus Medical Inc |
| Sep 16, 2019 | Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 fo... | The subject product measures 4.0mm in diameter instead of 3.5mm. | Class II | Synthes (USA) Products LLC |
| Sep 12, 2019 | Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Pr... | Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-ha... | Class II | Olympus Corporation of the Americas |
| Sep 5, 2019 | MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with ... | Modified outside of approved manufacturing process | Class II | Synthes (USA) Products LLC |
| Aug 7, 2019 | CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrume... | possibility of the sterility batch being insufficiently sterilized | Class II | Aesculap Implant Systems LLC |
| Aug 7, 2019 | CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrum... | possibility of the sterility batch being insufficiently sterilized | Class II | Aesculap Implant Systems LLC |
| Aug 6, 2019 | Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product ... | Products may contain the incorrect banner card within the kit | Class II | Arrow International Inc |
| Aug 6, 2019 | 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Cat... | Products may contain the incorrect banner card within the kit | Class II | Arrow International Inc |
| Jul 31, 2019 | SOMATOM go.All; Models #11061630 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography ... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.All; Models #11061638 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This compute... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Top; Models #11061648 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Top; Models #11061640 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 30, 2019 | Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with p... | Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 25, 2019 | syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomog... | SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 23, 2019 | Mammomat Revelation with software version VC10 and Biopsy Option Intended ... | An error can occur when performing a biopsy using the InSpect function. The acquisition workstati... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 18, 2019 | Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circ... | Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm ... | Class II | Arrow International Inc |
| Jul 10, 2019 | Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is t... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 10, 2019 | CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186 | The filter capacity is not achieved due to damage of the filter membrane. | Class II | B. Braun Medical, Inc. |
| Jul 9, 2019 | MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914 | Potential of an open port in the quench venting system when using the optional horizontal outlet ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 9, 2019 | MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915 | Potential of an open port in the quench venting system when using the optional horizontal outlet ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 9, 2019 | MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582 | Potential of an open port in the quench venting system when using the optional horizontal outlet ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 9, 2019 | MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643 | Potential of an open port in the quench venting system when using the optional horizontal outlet ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomograph... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tom... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomo... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography sys... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography sys... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomogra... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 20, 2019 | Cios Alpha VA20/ VA30 mobile X-Ray systems | DAP chamber may be missing an insulating foil | Class II | Siemens Medical Solutions USA, Inc |
| Jun 20, 2019 | Cios care fusion system | DAP chamber may be missing an insulating foil | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | Artis zee biplane MN, Model Number 10094143 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dFC, Model Number 7412807 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis TC, Model Number 7728350 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, 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.