Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 12, 2024 | Impella RP Flex with SmartAssist; Product Number: 1000323; | Optical Sensors have been damaged due to physical interaction between the inlet and another devic... | Class I | Abiomed, Inc. |
| Dec 12, 2024 | ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL ... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | Impella RP with SmartAssist; Product Number: 0046-0035; | Optical Sensors have been damaged due to physical interaction between the inlet and another devic... | Class I | Abiomed, Inc. |
| Dec 11, 2024 | nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extraco... | The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and Fle... | Class I | Nuwellis Inc |
| Dec 10, 2024 | Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Pa... | Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized ... | Class I | Mercury Enterprises, Inc. dba Mercury Medical |
| Dec 9, 2024 | Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model ... | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching fr... | Class I | Maquet Cardiovascular, LLC |
| Dec 9, 2024 | VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-400... | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching fr... | Class I | Maquet Cardiovascular, LLC |
| Dec 9, 2024 | JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L | Oxygen concentrator may melt or catch on fire during use. | Class I | JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD |
| Dec 6, 2024 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could ... | Class I | Fresenius Kabi USA, LLC |
| Nov 27, 2024 | Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic a... | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blo... | Class I | Trokamed GmbH |
| Nov 27, 2024 | Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic a... | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blo... | Class I | Trokamed GmbH |
| Nov 27, 2024 | Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic a... | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blo... | Class I | Trokamed GmbH |
| Nov 27, 2024 | Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic a... | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blo... | Class I | Trokamed GmbH |
| Nov 20, 2024 | StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number... | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... | Class I | Nova Biomedical Corporation |
| Nov 20, 2024 | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescri... | A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of errone... | Class I | Nova Biomedical Corporation |
| Nov 20, 2024 | StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. ... | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... | Class I | Nova Biomedical Corporation |
| Nov 14, 2024 | Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. ... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 14, 2024 | Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD722... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 14, 2024 | Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Mo... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 14, 2024 | Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: ... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 14, 2024 | Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Lo... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 14, 2024 | Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Stra... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 14, 2024 | Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. ... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 1, 2024 | Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM... | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the ext... | Class I | Medtronic Neurosurgery |
| Nov 1, 2024 | Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y... | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the ext... | Class I | Medtronic Neurosurgery |
| Oct 22, 2024 | Allegedly counterfeit batteries manufactured by CSB batteries being used with... | ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infu... | Class I | ICU Medical, Inc. |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 16, 2024 | Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607 | Baxter is aware of several recalls by other manufacturers related to the potential risk of expos... | Class I | Baxter Healthcare Corporation |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 862140... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 ... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRB... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CR... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | BioZorb Marker. Radiographic soft tissue marker. | Firm received reports of adverse events/complications that include serious injuries, such as pain... | Class I | Hologic, Inc |
| Oct 10, 2024 | Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CR... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
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.