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 |
|---|---|---|---|---|
| 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 |
| Jan 21, 2015 | Siemens LANTIS Oncology Information System Servers; allows the radiation the... | There is a potential safety risk when using LANTIS server software with operating systems with wh... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 16, 2015 | Artis One; The Artis One is an angiography system developed for diagnostic in... | The possibility exists that the monitor may fail and requires a power circle (shutdown and then p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 13, 2015 | Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PAC... | In case of a system crash, images may not be written to the hard disk and this may result in inco... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 13, 2015 | GE Inspection Technologies x|argos 160D system. Cabinet x-ray system. | It was discovered that the upper left corner-shaped lead shield in the window in one of the doors... | Class II | GE Inspection Technologies, LP |
| Jan 13, 2015 | GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system | It was discovered that the upper left corner-shaped lead shield in the window in one of the doors... | Class II | GE Inspection Technologies, LP |
| Jan 9, 2015 | Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial ... | Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the inco... | Class III | Arrow International Inc |
| Jan 5, 2015 | ARROW Epidural Needle Component (product number AN-05501). Epidural needles ... | The product labeling does not specify the 5 year shelf life of the product. | Class II | Arrow International Inc |
| Jan 2, 2015 | ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lume... | Foreign material found within the kits. The foreign material, white or black particles and/or thr... | Class II | Arrow International Inc |
| Jan 2, 2015 | Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR a... | Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registrat... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 29, 2014 | Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distribu... | Reports of customers falling from the Inversion Table and sustaining injuries. The Inversion Tabl... | Class II | Dick's Sporting Goods |
| Dec 19, 2014 | LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR ... | A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent prot... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 19, 2014 | Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is in... | In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric... | Class II | Synthes, Inc. |
| Dec 17, 2014 | Miethke Shunt System accessories Product Usage: - The Miethke Shunt Syst... | Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box lab... | Class II | Aesculap, Inc. |
| Dec 16, 2014 | Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POS... | the Instructions for Use (IFU) were inadvertently removed from the kit. | Class II | Arrow International Inc |
| Dec 15, 2014 | 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Int... | Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is... | Class II | Synthes, Inc. |
| Dec 15, 2014 | Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 an... | Potential for composed images to be flipped before being sent to PACS on systems with software v... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 15, 2014 | Malleable C- Retractor, Part Number 397.232, used to provide retraction of th... | Potential failure and/or corrosion of the internal spring of the retractor, which may have been m... | Class II | Synthes, Inc. |
| Dec 12, 2014 | R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube... | Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal... | Class II | Teleflex, Inc. |
| Dec 4, 2014 | Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: ... | There is the potential for a breach in the inner or outer packaging pouches of all lots of the Im... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Dec 4, 2014 | Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Number... | There is the potential for a breach in the inner or outer packaging pouches of all lots of the St... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
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.