Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoCla... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... | Class II | ICU Medical, Inc. |
| Dec 10, 2013 | Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The r... | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... | Class II | Zimmer, Inc. |
| Dec 10, 2013 | Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement T... | MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 lev... | Class II | Philips Medical Systems, Inc. |
| Dec 6, 2013 | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catal... | The housing to the Pump's driveline connector became partially or fully separated from the front ... | Class I | HeartWare Inc |
| Dec 5, 2013 | GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: Th... | Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... | Class II | GE Healthcare, LLC |
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.