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 |
|---|---|---|---|---|
| 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 |
| Jul 1, 2015 | 8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic m... | The possibility exists for intraoperative reamer head breakages which could also allow for un-ret... | Class II | Synthes (USA) Products LLC |
| Jun 30, 2015 | Artis zee/ zeego systems; dedicated angiography systems developed for single ... | in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray loc... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2015 | Axiom Artis systems, dedicated angiography systems developed for single and b... | The possibility exists for a large amount of liquid to seep through the top cover of the table an... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2015 | Artis Q systems; dedicated angiography systems developed for single and bipl... | The possibility exists for a large amount of liquid to seep through the top cover of the table an... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2015 | Siemens Artis zee systems; dedicated angiography systems developed for singl... | The possibility exists for a large amount of liquid to seep through the top cover of the table an... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 24, 2015 | 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and... | It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade. | Class II | Synthes (USA) Products LLC |
| Jun 24, 2015 | Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synth... | The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have... | Class II | Synthes (USA) Products LLC |
| Jun 22, 2015 | Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine... | the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fab... | Class II | Draeger Medical, Inc. |
| Jun 11, 2015 | SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and... | During certain clinical workflows safety issues may occur involving monitor assignment order and ... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 10, 2015 | Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intend... | The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversiz... | Class II | Synthes (USA) Products LLC |
| Jun 4, 2015 | SOMATOM Emotion 6; produce cross-sectional images of the body by computer rec... | A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix ... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2015 | SOMATOM Emotion 16; produce cross-sectional images of the body by computer re... | A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix ... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 3, 2015 | TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL... | A specific part and lot number was packaged and shipped prior to the completion of a required int... | Class II | Synthes, Inc. |
| May 28, 2015 | Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, ... | It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to br... | Class II | Synthes, Inc. |
| May 28, 2015 | Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction ... | Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an in... | Class II | Synthes, Inc. |
| May 27, 2015 | DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm... | certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0... | Class II | Synthes, Inc. |
| May 22, 2015 | Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego system... | There exists a possible position sensor fault in the swivel base axis not being detected by the s... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2015 | Syngo.via and Syngo.x ; a software solution intended to be used for viewing, ... | measurements drawn on the 2nd and subsequent images of the series are not visible on printouts wh... | Class II | Siemens Medical Solutions USA, Inc |
| May 13, 2015 | 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm ... | affected parts and lots of the Cannulated Drill Bits have the potential to break during use | Class II | Synthes, Inc. |
| May 13, 2015 | 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the C... | Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were foun... | Class II | Synthes, 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.