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 |
|---|---|---|---|---|
| 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. |
| Feb 5, 2014 | Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator ... | A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Ap... | Class II | Fisher Scientific Co |
| Jan 30, 2014 | Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws i... | The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, tap... | Class II | Synthes, Inc. |
| Jan 27, 2014 | syngo Dynamics Picture Archiving and Communication System (PACS). Model num... | Potential patient data mixup. Improper error handling could allow for two different patients to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 27, 2014 | Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade an... | Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label. | Class II | Synthes, Inc. |
| Jan 27, 2014 | Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillo... | One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored b... | Class II | Synthes, Inc. |
| Jan 27, 2014 | Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synt... | Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distribu... | Class II | Synthes, Inc. |
| Jan 21, 2014 | Buzzaround XL scooters' Product Usage: mobility | Buzzaround XL scooters' front to rear lockup can become unintentionally disengaged due to possibl... | Class II | Golden Technologies, Inc. |
| Jan 8, 2014 | SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sit... | Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Set... | Class II | B. Braun Medical, Inc. |
| Jan 7, 2014 | Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended f... | The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, ... | Class II | Synthes, Inc. |
| Jan 7, 2014 | Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia ... | The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assem... | Class II | Synthes, Inc. |
| Dec 23, 2013 | Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment... | The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L. | Class II | Aesculap, Inc. |
| Dec 16, 2013 | Siemens Artis zee Ceiling Systems. Angiographic x-ray system. | During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 13, 2013 | B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used f... | Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow... | Class II | B. Braun Medical, Inc. |
| Dec 10, 2013 | Draeger Infinity Acute Care System Monitoring Solution | After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was ... | Class II | Draeger Medical Systems, Inc. |
| Dec 9, 2013 | Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the Hi... | Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possibl... | Class II | Aesculap, Inc. |
| Dec 5, 2013 | Siemens Artis Q and Artis Q biplane systems Product Usage: Intervention... | There exists the possibility that during clinical operation, a breakdown of the x-ray tube could ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 21, 2013 | Medrad Veris MR Monitor units The system is intended to monitor physiolog... | The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and cou... | Class II | Medrad Mr Inc |
| Nov 21, 2013 | Normative Data Template CD for use with the I-Portal devices. Used to meas... | The data provided on the Normative Data Template CD for use with the I-Portal devices has not rec... | Class II | Neuro Kinetics, Inc. |
| Nov 15, 2013 | Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition ... | During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM D... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 13, 2013 | RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aeros... | Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and... | Class II | Instrumentation Industries Inc |
| Nov 8, 2013 | Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Mode... | Potential for a leak between the catheter and the bifurcate which would allow helium to escape to... | Class II | Arrow International Inc |
| Oct 15, 2013 | Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor... | One material batch used for production of the affected parts of the Synthes Material Mix were mix... | Class II | Synthes USA HQ, Inc. |
| Oct 14, 2013 | Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm... | Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve f... | Class II | Synthes (USA) Products LLC |
| Oct 9, 2013 | Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is use... | A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Oste... | Class II | Synthes USA HQ, Inc. |
| Oct 9, 2013 | Arrow Transradial Artery Access products Arrow Transradial Artery Access p... | There is a risk that the introducer needles packaged within the kits can be partially or fully oc... | Class II | Arrow International Inc |
| Oct 9, 2013 | Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripher... | A labeling inconsistency was discovered in which the lidstock states that the kit contains a stim... | Class II | Arrow International Inc |
| Oct 8, 2013 | Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for S... | Complaints were received which described the SynFix LR implant holder breaking at the interface b... | Class II | Synthes USA HQ, Inc. |
| Oct 3, 2013 | Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surg... | Complaints were received for intraoperative reamer head breakages which can allow for unretrieved... | Class II | Synthes USA HQ, Inc. |
| Oct 3, 2013 | Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be... | During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as S... | Class II | Synthes USA HQ, Inc. |
| Oct 3, 2013 | Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Ti... | A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical B... | Class II | Synthes USA HQ, 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.