Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 27, 2023 | Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470... | 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 6F 100CM MULTI PURPOSE, Catalog number M00310146... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466,... | 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 7F PRE-SHAPED 40 100CM, Catalog number M00310143... | 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 6F PRE-SHAPED 40 100CM, Catalog number M00310142... | 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-1TH190, BF-H190, BF-Q170, & BF-Q190. | 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-1T180, BF-1TQ180, BF-P180, & BF-Q180. | 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-XT190. | 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 | Henke-Ject-2 part luer sterile single use syringes - used for intravenous, in... | Sterile barrier might be damaged compromising the sterility of the device. | Class II | Wolf, Henke Sass, Gmbh |
| Jul 27, 2023 | Olympus Airway Mobilescope, Models MAF-GM & MAF-TM. | 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 7F PRE-SHAPED 40 90CM, Catalog number H965100430... | 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 8F PRE-SHAPED 40 100CM, Catalog number M00310144... | 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 100CM, Catalog number M00310162... | 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 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 8F PRE-SHAPED 40 90CM, Catalog number H965100440... | 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 8F 100CM MULTI PURPOSE, Catalog number M00310148... | 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-DP, LF-GP, & LF-TP. | 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, Model BF-Q180-AC | 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-MP190F. | 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 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V | Recent reports of patient infection. | 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 | 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 | 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 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 | 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 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-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 | 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 | 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 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 | 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 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 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 | 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 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 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 | 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 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 | 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 | 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 | 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 | 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 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 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 | 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 | 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 | NOxBOXi Nitric Oxide Delivery System | Replacement of the internal Sample Pump due to high failure rates. | Class II | NOXBOX LTD |
| 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. |
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.