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 |
|---|---|---|---|---|
| Jun 30, 2014 | Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Pi... | Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A ... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 17, 2014 | Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMEN... | Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncolo... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 13, 2014 | Titan T 5K Motor Product Usage: Low-speed motor is used with various att... | The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded i... | Class II | Dental EZ Group Star Dental Division |
| Jun 13, 2014 | Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable p... | Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4... | Class II | Aesculap, Inc. |
| Jun 10, 2014 | Animas Vibe Insulin Infusion Pump. This product is indicated for continuou... | Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was inco... | Class II | Animas Corporation |
| Jun 5, 2014 | AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee /... | There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 5, 2014 | Calcium Hydroxide Powder, USP For use in root canal therapy by health care... | One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed... | Class II | Axcentria Pharmaceuticals, LLC |
| Jun 5, 2014 | Artis zee and Artis zeego systems. x-ray, angiographic system | There is a potential problem with Artis zee and Artis zeego systems running software version VC21... | Class II | Siemens Medical Solutions USA, Inc |
| May 29, 2014 | Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius ... | The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found... | Class II | Synthes, Inc. |
| May 29, 2014 | STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22... | Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled... | Class II | B. Braun Medical, Inc. |
| May 28, 2014 | Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are inten... | The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about vi... | Class I | Childrens Medical Ventures |
| May 28, 2014 | Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic... | A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field... | Class II | Siemens Medical Solutions USA, Inc |
| May 19, 2014 | Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw Syste... | Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression ... | Class II | Small Bone Innovations |
| May 15, 2014 | Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use o... | An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address ... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2014 | Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming... | All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the pack... | Class II | Synthes, Inc. |
| May 13, 2014 | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep... | A limited number of DV5x Series CPAP units were manufactured and shipped without the serial numbe... | Class III | DeVilbiss Healthcare LLC |
| May 9, 2014 | Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobil... | There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the or... | Class II | Siemens Medical Solutions USA, Inc |
| May 9, 2014 | Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems ar... | Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generato... | Class II | Siemens Medical Solutions USA, Inc |
| May 6, 2014 | Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; L... | There is a potential risk when using LANTIS OIS System client software with operating systems for... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 29, 2014 | Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2... | Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use. | Class II | Synthes, Inc. |
| Apr 29, 2014 | Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infan... | The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring... | Class II | Childrens Medical Ventures |
| Apr 25, 2014 | MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis... | There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monit... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 24, 2014 | MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic r... | Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may ha... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 22, 2014 | Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Sh... | It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter ... | Class II | Synthes, Inc. |
| Apr 21, 2014 | Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt ... | AIC (USA) received information regarding 3 complaints in which the deflector did not move freely ... | Class II | Aesculap, Inc. |
| Apr 16, 2014 | DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies an... | DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction Syste... | Class I | Synthes, Inc. |
| Apr 15, 2014 | ReTurn 7500/7500 Aid, transfer | During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw an... | Class II | Handicare USA, Inc. |
| Apr 14, 2014 | Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introdu... | Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted... | Class II | Arrow International Inc |
| Apr 11, 2014 | AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a... | It was determined that under rare environmental conditions (i.e., extremely dry air in combinatio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 10, 2014 | Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixatio... | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result... | Class II | Synthes, Inc. |
| Apr 8, 2014 | Synthes XRL Medium Trial - Central Body, an instrument used as part of the Sy... | Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the inc... | Class II | Synthes, Inc. |
| Apr 7, 2014 | SBi RingFix Olive Wires Product Usage: These are temporary devices indica... | Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-30... | Class II | Small Bone Innovations, Inc. |
| Apr 3, 2014 | syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication... | A complaint reported that the archiving method at one customer site was changed from implicit to ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 3, 2014 | Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Contin... | There is a potential safety risk associated with potentially damaged locking pins within the brac... | Class II | Bayer Corp |
| Apr 3, 2014 | Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spina... | B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing th... | Class II | B. Braun Medical, Inc. |
| Apr 3, 2014 | Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PA... | Systems with the affected serial number are experiencing a software error which may lead to incor... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 1, 2014 | 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliv... | Table may lose calibration during patient treatment, which may cause the possibility of mistreatm... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 1, 2014 | Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray ... | Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerato... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 25, 2014 | Reusable latex breathing bags with multiple part numbers and sold as part of ... | Reusable latex breathing bags with various part numbers and sold as part of test lung and reusabl... | Class II | Draeger Medical, Inc. |
| Mar 24, 2014 | Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number C... | Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contai... | Class II | Arrow International Inc |
| Mar 21, 2014 | Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography... | The rubber damper may degrade and break, causing loosening of the motor mounting plates, which co... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2014 | Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Par... | The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted an... | Class I | Draeger Medical Systems, Inc. |
| Mar 5, 2014 | AXIOM Vertix MD Trauma systems radiographic X-ray | There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 13, 2014 | MULTIX FUSION. The Multix Fusion system is a radiographic system used in h... | It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system bec... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 11, 2014 | Trilogy Ventilators The Respironics Trilogy 100 system provides continuous o... | Internal testing revealed a potentially defective component on the power management board that co... | Class I | Phillips Respironics, Inc. |
| Feb 11, 2014 | The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Us... | The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 ins... | Class II | Synthes, Inc. |
| Feb 7, 2014 | Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care... | The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Crit... | Class I | Draeger Medical Systems, Inc. |
| Feb 7, 2014 | AXIOM Artis Systems Product usage: Artis zee is a family of dedicated ang... | Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriat... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 7, 2014 | Artis Zee Angiographic x-ray systems. | An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 5, 2014 | Synthes 5.0mm Variable Locking Screw This device is part of the Variable A... | Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 ... | 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.