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 |
|---|---|---|---|---|
| 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. |
| May 28, 2013 | StarDental Classique(TM) Diamond Dental Bur. Used for specific applicatio... | Recall was initiated because a manufacturing issue was found that prevented the diamond coating f... | Class II | Dental EZ Stardental Division |
| May 20, 2013 | Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tiss... | There is a possibility that the pump head was not shipped in the locked position. If the pump he... | Class II | Olympus America Inc. |
| May 13, 2013 | Siemens AXIOM Artis zeego x-ray, angiographic system | Siemens issued a customer safety notice about the overlay of system information after a functiona... | Class II | Siemens Medical Solutions USA, Inc |
| May 7, 2013 | Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system | Siemens became aware of an unintended behavior when using the Luminos dRF with software version V... | Class II | Siemens Medical Solutions USA, Inc |
| May 6, 2013 | Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with sof... | Siemens has discovered through product monitoring a potential malfunction when using system opera... | Class II | Siemens Medical Solutions USA, Inc |
| May 2, 2013 | Mobiletta Mira Mobile X-ray System | Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 26, 2013 | Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic s... | The firm became aware of a potential issue with Axiom Artis systems installed by a third party in... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 18, 2013 | Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 4... | Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been d... | Class II | Synthes USA HQ, Inc. |
| Apr 15, 2013 | Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synth... | Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive ... | Class II | Synthes USA HQ, Inc. |
| Apr 15, 2013 | DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs... | The firm is recalling these power cables due to a latent design reliability issue and the potenti... | Class II | Medrad Inc |
| Apr 11, 2013 | KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HO... | Some joints on the doors of a limited number of IDA beds may loosen or separate over time which c... | Class II | mobility unlimited inc |
| Apr 4, 2013 | 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Cont... | Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2... | Class II | B. Braun Medical, Inc. |
| Apr 4, 2013 | 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Cont... | Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2... | Class II | B. Braun Medical, Inc. |
| Apr 1, 2013 | 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an o... | Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, ... | Class II | Fresenius Medical Care Holdings, Inc. dba Renal... |
| Mar 12, 2013 | Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. | Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were n... | Class II | Custom Ultrasonics, Inc. |
| Mar 8, 2013 | Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, ... | A post market safety review following several customer complaints indicated additional clarificat... | Class II | Synthes USA HQ, Inc. |
| Mar 8, 2013 | Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal ... | Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled wi... | Class II | Synthes USA HQ, Inc. |
| Mar 8, 2013 | Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license i... | The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC2... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2013 | DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 8... | End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter c... | Class II | DeVilbiss Healthcare LLC |
| Mar 4, 2013 | Siemens syngo.plaza SW version VA20 with Mammography license. image proce... | Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syn... | Class II | Siemens Medical Solutions USA, 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.