Browse Device Recalls
2,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,969 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 2,969 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jul 17, 2018 | 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2 | The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen c... | Class II | Arrow International Inc |
| Jul 17, 2018 | 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr dou... | The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen c... | Class II | Arrow International Inc |
| Jul 12, 2018 | Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67 | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ ... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424 | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T11... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodi... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC0210... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 10, 2018 | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... | Class II | Arrow International Inc |
| Jul 10, 2018 | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... | Class II | Arrow International Inc |
| Jul 3, 2018 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip AR... | One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter.... | Class II | Arrow International Inc |
| Jun 29, 2018 | 3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product... | In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceilin... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2018 | 3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling... | In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceilin... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Cat... | The torque wrench used on the ceiling column assembly during a recent service visit was outside o... | Class II | Bayer Medical Care, Inc. |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Cat... | The torque wrench used on the ceiling column assembly during a recent service visit was outside o... | Class II | Bayer Medical Care, Inc. |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with... | The torque wrench used on the ceiling column assembly during a recent service visit was outside o... | Class II | Bayer Medical Care, Inc. |
| Jun 22, 2018 | Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10... | Potential hardware issue which may cause thermal effects and possible damage to system parts. | Class II | Siemens Medical Solutions USA, Inc |
| Jun 22, 2018 | ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Produ... | Potential hardware issue which may cause thermal effects and possible damage to system parts. | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2018 | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators... | In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for th... | Class I | Philips Respironics, 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 30, 2018 | ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000 | During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotatio... | Class II | Siemens Medical Solutions USA, Inc |
| May 25, 2018 | Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Art... | Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, w... | Class II | Siemens Medical Solutions USA, Inc |
| May 25, 2018 | AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is ... | Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, w... | Class II | Siemens Medical Solutions USA, Inc |
| May 24, 2018 | Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalat... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inh... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhala... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger 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.