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 |
|---|---|---|---|---|
| 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. |
| Jul 31, 2013 | Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumb... | Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction I... | Class II | Synthes USA HQ, Inc. |
| Jul 31, 2013 | 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixatio... | Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issu... | Class II | Synthes USA HQ, Inc. |
| Jul 31, 2013 | Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The ... | Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock state... | Class II | Arrow International Inc |
| Jul 31, 2013 | Slipped Capital Femoral Epiphysis System Product Usage: Intended for fra... | There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to sti... | Class II | Synthes USA HQ, Inc. |
| Jul 31, 2013 | Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Lar... | The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints ... | Class II | Synthes USA HQ, Inc. |
| Jul 31, 2013 | Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional... | All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction for... | Class II | Synthes USA HQ, Inc. |
| Jul 30, 2013 | Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifr... | The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is et... | Class II | Synthes USA HQ, Inc. |
| Jul 30, 2013 | Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for frac... | A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate. | Class II | Synthes (USA) Products LLC |
| Jul 30, 2013 | Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fi... | Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect label... | Class II | Synthes USA HQ, Inc. |
| Jul 30, 2013 | Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product ... | The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are e... | Class II | Synthes USA HQ, Inc. |
| Jul 30, 2013 | Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment... | The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole... | Class II | Synthes USA HQ, Inc. |
| Jul 30, 2013 | Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable a... | Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the n... | Class II | Synthes USA HQ, Inc. |
| Jul 30, 2013 | Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject P... | Complaints were received of inconsistencies in the expiration dates shown on the packaging of the... | Class II | Synthes USA HQ, Inc. |
| Jul 22, 2013 | 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.... | All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of break... | Class II | Synthes USA HQ, Inc. |
| Jul 17, 2013 | Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalo... | Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due ... | Class II | Arrow International Inc |
| Jul 17, 2013 | Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Cat... | The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW... | Class II | Arrow International Inc |
| Jul 16, 2013 | UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical inst... | Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially e... | Class II | Aesculap, Inc. |
| Jun 26, 2013 | ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21... | Siemens issued a customer safety advisory notice and field safety corrective action for a potenti... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 24, 2013 | SC2316, Distal Femoral Augment with Screw Total knee replacement due to os... | The firm became aware of an incident relating to a breach of sterility in the sterility barrier p... | Class II | Stelkast Co |
| Jun 22, 2013 | Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The M... | A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking ... | Class II | Synthes USA HQ, Inc. |
| Jun 18, 2013 | ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for v... | Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant -... | Class II | Aesculap, Inc. |
| Jun 12, 2013 | Synthes CMF Distraction System The product is intended for use as a bone s... | The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxill... | Class II | Synthes USA HQ, Inc. |
| Jun 11, 2013 | Synthes Flexible Medullary Reamer. Intended to be used to facilitate the p... | Due to the coiled design for this product, the product is difficult to clean and the potential fo... | Class II | Synthes USA HQ, Inc. |
| Jun 10, 2013 | syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo... | Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the s... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 5, 2013 | 5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit ... | DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. T... | Class II | Synthes USA HQ, Inc. |
| Jun 5, 2013 | Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab... | The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presen... | Class II | Fisher Scientific Co |
| Jun 5, 2013 | Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003.... | Siemens issued a Field Safety Notice about the potential hazard to patients or operators when usi... | Class II | Siemens Medical Solutions USA, Inc |
| May 31, 2013 | Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding ... | Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbe... | Class II | Synthes USA HQ, Inc. |
| May 31, 2013 | Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting... | The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column ... | Class II | Synthes (USA) Products LLC |
| May 29, 2013 | Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM T... | A plate was inadvertently released to a sales consultant that was restricted for sale. | 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.