Browse Device Recalls
2,609 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,609 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 2,609 FDA device recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 27, 2023 | Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M00310147... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS | Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mi... | Class II | Edwards Lifesciences, LLC |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-P190 & BF-XP190. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be att... | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exp... | Class II | Aomori Olympus Co., Ltd. |
| Jul 27, 2023 | Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60... | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-3C160. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M00310163... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-3C40 & BF-N20. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 26, 2023 | M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item N... | The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, a... | Class II | Zimmer, Inc. |
| Jul 26, 2023 | Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... | Class I | Hamilton Medical, Inc. |
| Jul 26, 2023 | Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral ... | A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 26, 2023 | Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... | Class I | Hamilton Medical, Inc. |
| Jul 26, 2023 | Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... | Class I | Hamilton Medical, Inc. |
| Jul 26, 2023 | Hamilton-MR1, REF: 161010, Intensive Care Ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... | Class I | Hamilton Medical, Inc. |
| Jul 26, 2023 | Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... | Class I | Hamilton Medical, Inc. |
| Jul 26, 2023 | Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... | Class I | Hamilton Medical, Inc. |
| Jul 25, 2023 | ZVU Functional GI Software, REF: ZVU-3 | GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. | Class III | Diversatek Healthcare |
| Jul 25, 2023 | The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluorosc... | Ground cable installed incorrectly. | Class II | Medtronic Navigation, Inc.-Littleton |
| Jul 25, 2023 | Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membra... | During rework of components during the manufacturing process, an additional piece of material may... | Class II | SenTec AG |
| Jul 25, 2023 | ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 1... | There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover im... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 24, 2023 | Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring ... | Sterility of device may be compromised due to breach of the chevron seal of the packaging | Class II | Cook Vandergrift, Inc. |
| Jul 24, 2023 | TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71... | A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL... | Class II | Smith & Nephew, Inc. |
| Jul 24, 2023 | TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71... | A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL... | Class II | Smith & Nephew, Inc. |
| Jul 21, 2023 | Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide ... | A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish ... | Class II | Keystone Industries |
| Jul 21, 2023 | Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live i... | Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-... | Class II | Ambu Inc. |
| Jul 20, 2023 | For intraventricular indications mainly used for operations within the brain ... | Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a ... | Class II | Aesculap Implant Systems LLC |
| Jul 20, 2023 | Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclav... | Reports were received the elastomer cup material is crumbling. | Class II | Cosmedent, Inc. |
| Jul 20, 2023 | PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the su... | Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthal... | Class II | Reichert, Inc. |
| Jul 20, 2023 | Visera Hysterovideoscope Olympus HYF Type V | IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brus... | Class II | Olympus Corporation of the Americas |
| Jul 20, 2023 | Zenition 70. The device is to be used in health care facilities both inside a... | Philips has become aware of the potential for unintended radiation exposure with Zenition 70 syst... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | NOxBOXi Nitric Oxide Delivery System | Replacement of the internal Sample Pump due to high failure rates. | Class II | NOXBOX LTD |
| Jul 19, 2023 | MultiDiagnost-Eleva | A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F42... | Weakened connection point on the adjustable suspension arm, potentially causing damage or a break. | Class II | IHB OPERATIONS B.V. |
| Jul 19, 2023 | Azurion | A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | Allura Xper series | A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product us... | As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Lab... | Class II | Randox Laboratories Ltd. |
| Jul 18, 2023 | PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter | Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflectin... | Class II | Smiths Medical ASD Inc. |
| Jul 18, 2023 | Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, S... | The healing abutments contain a dimensional condition that may lead to a gap between the healing ... | Class II | Preat Corp |
| Jul 18, 2023 | Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Ste... | The healing abutments contain a dimensional condition that may lead to a gap between the healing ... | Class II | Preat Corp |
| Jul 18, 2023 | Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: Th... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
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.