Browse Device Recalls
1,624 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,624 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 1,624 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H7... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), RE... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H74... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H74908... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL)... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF ... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), RE... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H7490... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), ... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 20, 2024 | 3M Durapore Surgical Tape, Catalog Number 1538-118 | Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled w... | Class II | 3M Company - Health Care Business |
| Mar 19, 2024 | Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Ca... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 ... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Clearview Blower/Mister, Model Number 22120 | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model ... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip,... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring ... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Mode... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt,... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model ... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Mode... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 11, 2024 | Ureteral dilator, REF RBD014 | A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facil... | Class II | Coloplast Manufacturing US, LLC |
| Mar 6, 2024 | KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b... | The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminate... | Class II | Microbiologics Inc |
| Mar 5, 2024 | DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device use... | Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Int... | Class II | Beckman Coulter, Inc. |
| Mar 5, 2024 | OptiCross Coronary Imaging Catheter, REF H749518080120 | Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect vo... | Class II | Boston Scientific Corporation |
| Feb 29, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometri... | The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) ass... | Class II | Beckman Coulter, Inc. |
| Feb 27, 2024 | CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the foll... | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... | Class I | Smiths Medical ASD Inc. |
| Feb 27, 2024 | CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following ... | CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following ... | Class I | Smiths Medical ASD Inc. |
| Feb 27, 2024 | CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, a... | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... | Class I | Smiths Medical ASD Inc. |
| Feb 26, 2024 | NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 | Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, t... | Class II | Navinetics Inc |
| Feb 20, 2024 | Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilit... | Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Int... | Class II | Boston Scientific Corporation |
| Feb 20, 2024 | 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; ... | Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top fil... | Class II | 3M Company - Health Care Business |
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.