Browse Device Recalls
214 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 214 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 214 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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. |
| Jul 20, 2018 | CE18TKPS CONT EPIDURAL TRAY (LF), Material Number 332216 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 | CONTIPLEX TUOHY SET, 18GX6", 1.3X150MM, Material Number 331694 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 | CE18TBLS CONT EPIDURAL TRAY, Material Number 332219 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 | CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 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 | CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 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 2 IN CONT. PNB SET, Material Number 331673 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 | EPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 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 | CE17TKCD CONT EPIDURAL ANESTHESIA KIT, Material Number 332229 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 | CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 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 | CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 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 | CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 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 | CNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 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 | CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 Connectio... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jun 4, 2018 | 26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog N... | There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a ... | Class II | B. Braun Medical, Inc. |
| May 9, 2018 | Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Produ... | There is a potential for a different set to be mixed within the lot, where the incorrect set does... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthes... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of ... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthes... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local ... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051,... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252.... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anes... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075,... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local ... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jul 29, 2016 | Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start... | Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) ... | Class II | B. Braun Medical, Inc. |
| Jul 11, 2016 | Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DEx... | B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tr... | Class II | B. Braun Medical, Inc. |
| Apr 26, 2016 | WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous deliver... | Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle gu... | Class II | B. Braun Medical, Inc. |
| Apr 14, 2016 | Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: ... | BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... | Class II | B. Braun Medical, Inc. |
| Apr 14, 2016 | Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve ... | BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... | 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.