Browse Device Recalls
2,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,969 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 2,969 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 12, 2016 | Mammomat Inspiration with Tomosynthesis functionality | A potential system fatal error may occur during tomosynthesis reconstruction with large breasts t... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 4, 2016 | Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation. | The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation C... | Class I | Draeger Medical, Inc. |
| Jan 29, 2016 | software for Syngo Dynamics a Picture Archiving and Communication System ... | Siemens is releasing a software update that addresses an issue of mixing data from multiple patie... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 28, 2016 | Large Volume Paracentesis Kit is packaged in a thermaformed tray which contai... | Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the ab... | Class II | Gi Supply |
| Jan 25, 2016 | Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Mo... | Siemens' conducting a recall due to a potential issue when using the measurement package of the V... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 18, 2016 | A Picture Archiving and Communication System (PACS) intended to display, proc... | To inform users about the possible incorrect values for Distance Measurements when using certain ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 18, 2016 | Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbi... | Software Issue | Class II | Philips Respironics |
| Jan 15, 2016 | OraQuick HCV Visual Reference Panel Intended to assist new operation in b... | OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Ant... | Class III | OraSure Technologies, Inc. |
| Jan 12, 2016 | Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07... | Arrow has issued a recall for these products due to potential packaging damage. The sterility of ... | Class II | Arrow International Inc |
| Jan 8, 2016 | Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: T... | Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenos... | Class II | Olympus Corporation of the Americas |
| Jan 7, 2016 | Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast De... | Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the ... | Class II | Wfr/aquaplast Corp |
| Jan 6, 2016 | Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw... | DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Can... | Class II | Synthes (USA) Products LLC |
| Dec 22, 2015 | Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus V... | Drager became aware of situations where the error message "Poti unplugged" was generated causing ... | Class I | Draeger Medical, Inc. |
| Dec 22, 2015 | Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: ... | Drager became aware of situations where the error message "Poti unplugged" was generated causing ... | Class I | Draeger Medical, Inc. |
| Dec 22, 2015 | Syngo Plaza Picture archiving and communication system. Software only. PACS... | Siemens is releasing an updated software version to address several software issues including RGB... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2015 | The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CL... | The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing ... | Class II | Therakos Inc |
| Dec 16, 2015 | GE Inspection Technologies, LP, Cabinet X-ray system used for industrial qual... | GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems ma... | Class II | GE Inspection Technologies, LP |
| Dec 8, 2015 | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... | Class II | Synthes (USA) Products LLC |
| Dec 8, 2015 | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... | Class II | Synthes (USA) Products LLC |
| Dec 8, 2015 | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... | Class II | Synthes (USA) Products LLC |
| Dec 8, 2015 | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... | Class II | Synthes (USA) Products LLC |
| Dec 8, 2015 | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... | Class II | Synthes (USA) Products LLC |
| Dec 7, 2015 | MAGNETOM systems, magnetic resonance diagnostic devices (MRDD). | Possible installation error of the quench lines of superconducting magnets, used to vent helium g... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 1, 2015 | Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN... | The firm became aware of cases in which the battery run times of the optional PS 500 power supply... | Class I | Draeger Medical, Inc. |
| Dec 1, 2015 | SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexi... | The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual di... | Class II | Synthes (USA) Products LLC |
| Nov 30, 2015 | Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDR... | The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tub... | Class II | Bayer Healthcare |
| Nov 30, 2015 | Columbus Revision Knee System, EnduRo Knee System Product Usage: The Colu... | Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem impla... | Class II | Aesculap, Inc. |
| Nov 18, 2015 | Software version VD10E for Syngo X-Workplace; Picture archiving and communica... | Potential post-processing software issue when using tabcard "4D" on X-Workplace with software ver... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 17, 2015 | Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retra... | AAG received a customer complaint that corrosion had been found by a hospitals central sterile s... | Class II | Aesculap, Inc. |
| Nov 17, 2015 | Syngo Imaging XS is a Picture Archiving and Communication System (PACS) | For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in inco... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 17, 2015 | Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm... | A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. E... | Class II | Olympus Corporation of the Americas |
| Nov 12, 2015 | Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthet... | There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Wor... | Class I | Draeger Medical, Inc. |
| Nov 10, 2015 | Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG:... | The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris... | Class II | Aesculap, Inc. |
| Nov 10, 2015 | Tray Set containing multiple instruments and may contain the flexible bone aw... | The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris... | Class II | Aesculap, Inc. |
| Nov 10, 2015 | Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG ... | The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris... | Class II | Aesculap, Inc. |
| Nov 10, 2015 | Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aescul... | The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris... | Class II | Aesculap, Inc. |
| Nov 2, 2015 | Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/R... | TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent ... | Class II | Synthes (USA) Products LLC |
| Nov 2, 2015 | 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixat... | It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the inco... | Class II | Synthes (USA) Products LLC |
| Oct 30, 2015 | Artis systems with large display from Siemens Medical Solutions USA, Inc. In... | Due to improper soldering in a limited number of large display bypass module components of a spec... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 28, 2015 | Syngo Imaging VB36D_HF02. Radiological image processing system. | To provide supplementary information regarding the release of the syngo Imaging Software Version ... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2015 | Synthes Application Instrument for Sternal ZIPFIX. Indications for use incl... | Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on Au... | Class II | Synthes (USA) Products LLC |
| Oct 16, 2015 | ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ... | Possibility that the catheter peel-away component hub tabs may prematurely detach when the pract... | Class II | Arrow International Inc |
| Oct 8, 2015 | Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 t... | These lots of Oxygen Dial Regulators could have the settings label off by one position. When the ... | Class II | Precision Medical, Inc. |
| Oct 8, 2015 | Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/... | The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indi... | Class II | Synthes (USA) Products LLC |
| Oct 7, 2015 | Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324... | The affected part number and lot listed above is incorrectly etched with the wrong part number an... | Class II | Synthes (USA) Products LLC |
| Oct 6, 2015 | 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes mod... | Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw. | Class II | Synthes (USA) Products LLC |
| Sep 28, 2015 | Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile... | The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.41... | Class II | Synthes (USA) Products LLC |
| Sep 24, 2015 | MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis. | Display freeze of MODULARIS hand control results in information not being updated on the display.... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 23, 2015 | Ventilator Tubing | As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product reca... | Class II | Instrumentation Industries Inc |
| Sep 21, 2015 | Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. ... | Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the ... | Class II | Synthes (USA) Products LLC |
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.