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 |
|---|---|---|---|---|
| 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. |
| May 6, 2015 | syngo Workflow SLR; The information system syngo Workflow SLR is a digital ra... | A potential exists for order transactions from interfaced HIS (Hospital Information System) syste... | Class II | Siemens Medical Solutions USA, Inc |
| May 5, 2015 | Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ra... | under certain circumstances the Cios Alpha system may freeze during a procedure. | Class II | Siemens Medical Solutions USA, Inc |
| May 5, 2015 | ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression,... | potential safety risk of collision of the LINAC gantry with the patient or the treatment table i... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 30, 2015 | I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display... | complaints of system malfunction and unintended, sudden movement at start up. No injuries reported. | Class II | Neuro Kinetics, Inc. |
| Apr 20, 2015 | SOMATOM Perspective; the intended use of computed tomography is to produce cr... | Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2015 | SOMATOM Emotion 16, the intended use of computed tomography is to produce cro... | Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2015 | SOMATOM Emotion 6; the intended use of computed tomography is to produce cros... | Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 14, 2015 | AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray... | If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system,... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radi... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fl... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medi... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 9, 2015 | TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractur... | TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the ... | Class II | Synthes, Inc. |
| Mar 27, 2015 | CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous... | There is a potential for a hole to be present in the outer tray of a limited number of pain contr... | Class II | B. Braun Medical, Inc. |
| Mar 26, 2015 | EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument ha... | New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope... | Class II | Olympus America Inc. |
| Mar 26, 2015 | Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound o... | The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not cons... | Class II | PhotoMedex, Inc. |
| Mar 26, 2015 | ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item... | Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force w... | Class II | Handicare USA, Inc. |
| Mar 19, 2015 | Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography syst... | potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connectio... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 9, 2015 | MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indic... | The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that g... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 26, 2015 | Vitagel; indicated in surgical procedures (other than in neurosurgical and op... | Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Feb 24, 2015 | Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aimin... | The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and rem... | Class II | Synthes, Inc. |
| Feb 18, 2015 | Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to... | Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/re... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 17, 2015 | Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femora... | For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead ... | Class II | Synthes, Inc. |
| Feb 16, 2015 | Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D... | Locking pegs were not locking during distal radius procedures. There has been one (1) report of r... | Class II | Flower Orthopedics Corporation |
| Feb 6, 2015 | SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA... | Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 5, 2015 | Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lum... | Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Tr... | Class II | Medical Components, Inc dba MedComp |
| Feb 5, 2015 | ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Cod... | Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rat... | Class II | Arrow International Inc |
| Feb 3, 2015 | Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elasti... | The Inserter has the potential for mechanical failures such as breakage of the main shaft of the ... | Class II | Synthes, Inc. |
| Jan 28, 2015 | 9F Plastic Dual Port; The port systems are totally implantable vascular acces... | The dual port with catheters was not covered under FDA clearance. | Class II | Medical Components, Inc dba MedComp |
| Jan 21, 2015 | Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 2... | Drug products contained within the kits may have been rendered ineffective by a duplicate sterili... | Class II | Medical Components, Inc dba MedComp |
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.