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 |
|---|---|---|---|---|
| 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 |
| Mar 4, 2013 | Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berma... | The product specifications sheet, part of the Instructions for Use (IFU), for the specified produ... | Class II | Arrow International Inc |
| Mar 1, 2013 | Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to... | There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over t... | Class II | B. Braun Medical, Inc. |
| Feb 28, 2013 | Siemens Mammomat Inspiration - full-field digital mammography Product Usa... | Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 22, 2013 | Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: ... | The Trial Head may come loose from the implant stem during manipulation of the arm during surgery... | Class II | Synthes USA HQ, Inc. |
| Feb 22, 2013 | Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000... | The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to th... | Class II | Synthes USA HQ, Inc. |
| Feb 4, 2013 | The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep... | The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath... | Class II | Arrow International Inc |
| Jan 31, 2013 | Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Pr... | During the course of product monitoring, Siemens became aware of a tolerance problem in the power... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 24, 2013 | Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC345... | Firm was made aware of incidents relating to the difficulty of properly engaging and securing the... | Class II | Stelkast Co |
| Jan 21, 2013 | Artis zee systems x-ray, angiographic system | The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135,... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 18, 2013 | Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical... | The bipolar energy did not stop after release of the foot pedal. | Class II | Aesculap, Inc. |
| Jan 15, 2013 | Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos... | Siemens has become aware of a potential malfunction and possible hazard to patients and staff whe... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 11, 2013 | Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number ... | This recall is being initiated in response to complaints received where it was reported that the ... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Large Combination Clamp/Large External Fixation System, Part Number 390.005 ... | The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm socket... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. Fo... | There is the potential for the anterior footplates to not fit onto the Titanium Midface Distracto... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Par... | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to ... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Flexible Grip which is part of the Synthes Universal Nail System. Indicate... | Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part ... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular ... | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to ... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, P... | It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Pa... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Par... | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to ... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread L... | Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly et... | Class II | Synthes USA HQ, Inc. |
| Jan 11, 2013 | Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also kn... | The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Den... | Class II | Synthes USA HQ, Inc. |
| Jan 4, 2013 | The product is labeled in part "***Surgical Laser Technologies, Inc. Montgome... | Firm became aware that some products within the specified lot may not have been sealed appropriat... | Class II | PhotoMedex, Inc. |
| Jan 3, 2013 | Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indic... | Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pu... | Class I | Animas Corporation |
| Dec 17, 2012 | Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infu... | Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on J... | Class III | Animas Corporation |
| Dec 17, 2012 | Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F... | Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" ne... | Class II | Vygon Corporation |
| Dec 13, 2012 | REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product ... | The affected product was packaged with the incorrect introducer needle. The kit label indicates ... | Class II | Medical Components, Inc dba MedComp |
| Dec 13, 2012 | Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number... | The displayed value for the invasive blood pressure measurement of the IACS was different than th... | Class II | Draeger Medical, Inc. |
| Nov 29, 2012 | Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath ... | Firm became aware that two handsets in the affected batches became inoperable while the user was ... | Class II | Handicare Accessibility |
| Nov 27, 2012 | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 4... | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessi... | Class II | Arrow International Inc |
| Nov 27, 2012 | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr ... | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessi... | Class II | Arrow International 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.