Browse Device Recalls
2,939 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,939 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 2,939 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Sep 18, 2015 | 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic cathete... | Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card... | Class II | Arrow International Inc |
| Sep 14, 2015 | Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates an... | Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120... | Class II | Synthes (USA) Products LLC |
| Sep 11, 2015 | MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a con... | small puncture marks in a sterile package for an accessory to an Olympus device | Class II | Olympus Corporation of the Americas |
| Sep 4, 2015 | 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Uni... | This product was produced using a finishing process not identified as part of the manufacturing s... | Class II | Synthes (USA) Products LLC |
| Sep 3, 2015 | Inserter for Titanium Elastic Nails (TEN), orthopedic device | potential for mechanical failures such as breakage. | Class II | Synthes (USA) Products LLC |
| Aug 31, 2015 | Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The S... | The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled M... | Class II | Synthes (USA) Products LLC |
| Aug 27, 2015 | Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes | Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the ... | Class II | Arrow International Inc |
| Aug 27, 2015 | Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesth... | Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during... | Class II | B. Braun Medical, Inc. |
| Aug 21, 2015 | EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscop... | Insufficient information for specific cleaning accessories used for the cleaning and reprocessing... | Class II | Olympus Corporation of the Americas |
| Aug 20, 2015 | Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous ... | Two isolated instances of holes in the outer header bag component of the double barrier sterile p... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Aug 18, 2015 | SOMATOM Force; computed tomography x-ray system. Intended to generate and ... | Software and firmware bugs | Class II | Siemens Medical Solutions USA, Inc |
| Aug 17, 2015 | CIOS ALPHA; image intensified fluoroscopic x-ray system | patient procedure interruption due to a potential system failure | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | SOMATOM Definition Flash; intended to produce cross-sectional images of the b... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | SOMATOM Definition AS, intended to produce cross-sectional images of the body... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | SOMATOM Definition Edge; intended to produce cross-sectional images of the bo... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 11, 2015 | Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm;... | DLS pin breakage during planned implant removal, after uneventful and successful healing of the f... | Class II | Synthes (USA) Products LLC |
| Aug 11, 2015 | Syngo RT Oncologist, an optional accessory to the linear accelerator system a... | This update is intended to provide a software update for the Syngo RT Oncologist, which is curren... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 5, 2015 | ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, P... | A software fix has been released to prevent automatic movement resulting in a collision safety ri... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 4, 2015 | Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilize... | Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional Ne... | Class II | Bayer Healthcare |
| Jul 30, 2015 | PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeut... | the catheter peel-away component hub tabs may prematurely detach. One injury reported. | Class II | Arrow International Inc |
| Jul 30, 2015 | Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Comp... | saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the cath... | Class II | Arrow International Inc |
| Jul 29, 2015 | VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also know... | The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the c... | Class II | Synthes (USA) Products LLC |
| Jul 29, 2015 | Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sci... | Potential for micropores to form, allowing fluid to enter the hollow handle. | Class II | Synthes (USA) Products LLC |
| Jul 29, 2015 | Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) an... | Labeling changes were made related to MR conditions that align with standard definitions for MR S... | Class II | Synthes (USA) Products LLC |
| Jul 22, 2015 | Synthes Application Instrument for Sternal ZIPFIX; indications for use includ... | The end cap may loosen and detach making the instrument non-functional. No injuries reported. | Class II | Synthes (USA) Products LLC |
| Jul 21, 2015 | Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test;... | The devices that included the OVAR research test were not cleared for marketing and mTBI research... | Class II | Neuro Kinetics, Inc. |
| Jul 13, 2015 | PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended fo... | The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V... | Class I | Draeger Medical, Inc. |
| Jul 7, 2015 | S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal... | A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break... | Class II | Aesculap, Inc. |
| Jul 6, 2015 | Syngo.plaza; picture archiving and communications system Product Usage: S... | Potential issue leading to data loss and patient data mix-up | Class II | Siemens Medical Solutions USA, Inc |
| Jul 1, 2015 | Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap ... | The wrap is for single use for nail sterilization but does not have sufficient testing for the de... | 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.