Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 20, 2018 | NES1727KFX W /17GA TUOHY 19GA SPRW OT, Material Number 333197 Connection ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | EC20CST 20G CLSD SOFT TIP CATH, Material Number 333521 Connection device ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 Connection device us... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 Connectio... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | ES1725K SPINAL/EPIDURAL TRAY, Material Number 333165 Connection device us... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18H CONT EPIDURAL SET, Material Number 332210 Connection device used by... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18TK ACCU-BLOC PERIFIX KIT, Material Number 332220 Connection device us... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TFC CONTINUOUS EPID SET W/17G TUOHY, Material Number 332238 Connectio... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | BULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N Connecti... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TF PERIFIX FX CONTIN. EPIDURAL SET, Material Number 332234 Connection... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18TB CONT EPIDURAL TRAY, Material Number 332222 Connection device used ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | EPID. CATH. NG, 20GA. CLOSED TIP-LF, Material Number 333541 Connection de... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | ES1725KFX ESPOCAN SPINAL/EPID. TRAY, Material Number 333196 Connection de... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17T CONT EPIDURAL SET, Material Number 332202 Connection device used by... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | GOVCE18TKST CONT EPID W/SOFT TIP, Material Number 332604 Connection devic... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 Connection device ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612 | The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been ... | Class II | Zimmer Biomet, Inc. |
| Jul 20, 2018 | CE17TK19CDP CONT EPIDURAL TRAY, Material Number 332262 Connection device ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | EC19OF SPRINGWOUND 19G EPID CATHETER, Material Number 333514 Connection d... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18HKCD CONT EPIDURAL TRAY, Material Number 332206 Connection device use... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | EC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 Connection ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connectio... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY, Material Number 332143 Connection... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TB CONT EPIDURAL TUOHY, Material Number 332224 Connection device used... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 Connection... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18T CONT EPIDURAL SET, Material Number 332200 Connection device used by... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18TKCD10L 18GA TUOHY/10CC GLAS, Material Number 332217 Connection devic... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | EC20CS EPIDURAL CATHETER, Material Number 333532 Connection device used b... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129 Connecti... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CONTI ECHO CT W/2IN TUOHY ULTRA 360 SET, Material Number 331767 Connectio... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CONTIPLEX TUOHY ULTRA 4 IN CNB400TU, LF, Material Number 331691 Connectio... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TKF PERIFIX CONTIN. EPIDURAL TRAY, Material Number 332086 Connection ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | EC20O 20G X 100CM CATH OPEN TIP LF, Material Number 333520 Connection dev... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 Connection de... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CONT STIM BASIC KIT W/2 IN INSUL TUOHY, Material Number 331757 Connection... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 Connection ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CEP18TKO CONT. EPIDURAL PEDIATRIC KIT, Material Number 332290 Connection ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TKCDLS CONT EPIDURAL TRAY, Material Number 332212 Connection device u... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18TKDP CONT EPID/DURAPREP, Material Number 332215 Connection device use... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | ES1827QK ESPOCAN COMBINED 27GA, Material Number 333182 Connection device ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TKFCY 17GA SAFETY TUOHY NEEDLE TRAY, Material Number 332075 Connectio... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TKFSDT EPID TRAY W/17GA FIXED WING, Material Number 332093 Connection... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CCE18HK10L CONT EPIDURAL TRAY, Material Number 332264 Connection device u... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TKFCPS EPIDURAL FULL TRAY, Material Number 332078 Connection device u... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TKST CONT EPID W/SOFT TIP, Material Number 332082 Connection device u... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | ESPOCAN SPINAL/EPID TRAY W/ 18G TUOHY, Material Number 333193 Connection ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629 | The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been ... | Class II | Zimmer Biomet, Inc. |
| Jul 20, 2018 | SCNB4TK CONT STIM W/4 INCH INSUL TUOHY, Material Number 331756 Connection... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | EC20C 20G X 100CM CATH CLOSED, Material Number 333540 Connection device u... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, 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.