Browse Device Recalls
607 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 607 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 607 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 18, 2014 | Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valv... | ICU has become aware of an issue with a component where the connection on an arterial monitoring ... | Class II | ICU Medical, Inc. |
| Jul 18, 2014 | Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze... | ICU has become aware of an issue with a component where the connection on an arterial monitoring ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoCl... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron F... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating L... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Nee... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rot... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Lue... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rota... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connect... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave",... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 17 cm (7'') Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoC... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item #... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Lue... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv C... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClav... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rota... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, R... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps,... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, P... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 78" Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoCl... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, R... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender R... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClav... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector,... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syp... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Par... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Co... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, ... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings)... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Sipho... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps,... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connec... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 24, 2013 | 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B330... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU 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.