Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 11, 2013 | AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identificat... | Kits incompatible with certain fluorescence microscope light sources | Class III | AdvanDx, Inc. |
| Dec 10, 2013 | Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement T... | MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 lev... | Class II | Philips Medical Systems, Inc. |
| Dec 5, 2013 | Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 ... | X-ray system C-arm casting may loosen and fall | Class II | Philips Medical Systems, Inc. |
| Nov 25, 2013 | Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plasti... | Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of ste... | Class II | Navilyst Medical, Inc. |
| Nov 20, 2013 | TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Univ... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 20, 2013 | Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to sec... | Mismarked and unmarked screws | Class II | SpineFrontier, Inc. |
| Nov 20, 2013 | Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the In... | Mismarked and unmarked screws | Class II | SpineFrontier, Inc. |
| Nov 20, 2013 | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-801... | Screw inserters may not mate properly with hex interface of the screws. | Class II | SpineFrontier, Inc. |
| Nov 20, 2013 | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-801... | Screw inserters may not mate properly with hex interface of the screws. | Class II | SpineFrontier, Inc. |
| Nov 20, 2013 | TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Unive... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 20, 2013 | TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Univ... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 20, 2013 | Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to s... | Mismarked and unmarked screws | Class II | SpineFrontier, Inc. |
| Nov 20, 2013 | Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to se... | Mismarked and unmarked screws | Class II | SpineFrontier, Inc. |
| Nov 20, 2013 | TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Unive... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 20, 2013 | TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Inte... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 20, 2013 | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-8... | Screw inserters may not mate properly with hex interface of the screws. | Class II | SpineFrontier, Inc. |
| Nov 20, 2013 | TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Univ... | Sterility of device may be compromised due to lack of pouch seal integrity | Class II | Boston Scientific Corporation |
| Nov 15, 2013 | HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | Class II | Instrumentation Laboratory Co. |
| Nov 15, 2013 | HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | Class II | Instrumentation Laboratory Co. |
| Nov 15, 2013 | HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | Class II | Instrumentation Laboratory Co. |
| Nov 13, 2013 | Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD... | KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int... | Class II | Karl Storz Endoscopy America Inc |
| Nov 13, 2013 | Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009B... | KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int... | Class II | Karl Storz Endoscopy America Inc |
| Nov 12, 2013 | Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2... | 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirc... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 6, 2013 | Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatolo... | Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch an... | Class II | Candela Corporation |
| Nov 6, 2013 | Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeo... | KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper w... | Class II | Karl Storz Endoscopy America Inc |
| Nov 5, 2013 | Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M00625022... | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... | Class II | Boston Scientific Corporation |
| Nov 5, 2013 | Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M006250228... | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... | Class II | Boston Scientific Corporation |
| Nov 5, 2013 | Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M006250228... | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ... | Class II | Boston Scientific Corporation |
| Oct 30, 2013 | Easy Diagnost Eleva Universal Fluoroscopic applications | The delivered application software was an outdated version to the model of equipment. | Class II | Philips Medical Systems, Inc. |
| Oct 23, 2013 | BrightView XCT is a gamma camera for Single Photon Emission Computed Tomograp... | It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the ti... | Class II | Philips Medical Systems, Inc. |
| Oct 21, 2013 | Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS19... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, T... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Att... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZR... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PR... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Med... | Class I | Medtronic Vascular |
| Oct 21, 2013 | COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT19... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 21, 2013 | THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 18, 2013 | PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw im... | During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8... | Class II | SpineFrontier, Inc. |
| Oct 14, 2013 | Philips Multi Diagnost Eleva with FlatDetector | The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of t... | Class II | Philips Medical Systems, Inc. |
| Oct 14, 2013 | Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Lib... | Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result ... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 14, 2013 | Philips Multi Diagnost Eleva II | The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of t... | Class II | Philips Medical Systems, Inc. |
| Oct 11, 2013 | TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes ... | Incorrect instructions for use (IFU). | Class I | Codman & Shurtleff, Inc. |
| Oct 11, 2013 | TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube o... | Incorrect instructions for use (IFU). | Class I | Codman & Shurtleff, Inc. |
| Oct 10, 2013 | Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactat... | Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell le... | Class II | Nova Biomedical Corporation |
| Oct 9, 2013 | Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX | NT2000iX software shipped with the international setting turned on. The international settings in... | Class II | Neurotherm, Inc. |
| Sep 27, 2013 | OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-US... | Alcohol Prep Pads contained within the kit are not properly labeled. | Class II | Insulet Corporation |
| Sep 27, 2013 | OmniPod Insulin Management Product Demonstration Kit; Model Reference Number:... | Alcohol Prep Pads contained within the kit are not properly labeled. | Class II | Insulet Corporation |
| Sep 24, 2013 | Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81... | Handles and heads may not be compatible. | Class II | SpineFrontier, Inc. |
| Sep 24, 2013 | Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates tha... | Handles and heads may not be compatible. | Class II | SpineFrontier, 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.