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 |
|---|---|---|---|---|
| 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. |
| Oct 1, 2013 | Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated ... | There is an issue associated with Digital Pathology System (DPS) Software, in which the annotatio... | Class II | Omnyx Llc |
| Sep 30, 2013 | Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in ... | Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive... | Class II | Draeger Medical, Inc. |
| Sep 30, 2013 | Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P ... | A potential non conformance was identified with the Zero-P VA plate where the screw could back ou... | Class II | Synthes USA HQ, Inc. |
| Sep 27, 2013 | TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm,... | Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures... | Class II | Olympus America Inc. |
| Sep 27, 2013 | B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 42... | One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is... | Class II | B. Braun Medical, Inc. |
| Sep 24, 2013 | Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates ea... | The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is ove... | Class II | Synthes USA HQ, Inc. |
| Sep 20, 2013 | Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US) | The trial insertion instrument may disassemble during use due to a potentially weak weld on then ... | Class II | Aesculap, Inc. |
| Sep 20, 2013 | MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended f... | The root cause investigation showed that the under-volume hazard can occur when the unit has bee... | Class II | Medrad Inc dba Bayer R&I |
| Sep 19, 2013 | Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 | The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not comp... | Class II | Aesculap, Inc. |
| Sep 11, 2013 | The Artis zee / zeego Angiography System is designed as a set of components t... | There is a potential issue on running Artis systems running software VC1x software if a network p... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 10, 2013 | Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar ... | Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did... | Class II | Aesculap, Inc. |
| Sep 6, 2013 | Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rH... | The recall was initiated due to an increased risk of implants breaching the sterile pouches insid... | Class II | Small Bone Innovations, Inc. |
| Sep 3, 2013 | Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software ve... | When using systems operating with software versions VD10A/G during a RAD examination, a malfuncti... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 3, 2013 | (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Urosko... | A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 28, 2013 | Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with sof... | When using systems operating with software versions VD10A/G during a RAD examination, a malfuncti... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 28, 2013 | Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse ... | The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured. | Class II | Globus Medical, Inc. |
| Aug 14, 2013 | Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product... | During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia mach... | Class I | Draeger Medical, Inc. |
| Aug 13, 2013 | Synthes Application Instrument Sternal Zip Flex System intended for use in... | When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant wh... | Class II | Synthes USA HQ, Inc. |
| Aug 5, 2013 | Outlook Safety Infusion System Burette Set. For intravenous fluid administ... | Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Pro... | Class II | B. Braun Medical, Inc. |
| Aug 1, 2013 | Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates e... | The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malf... | 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.