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Browse Device Recalls

590 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 590 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 590 FDA device recalls.

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DateProductReasonClassFirm
Jul 31, 2017 100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clav... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotat... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, R... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, S... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand P... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿,... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotatin... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Rem... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gan... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer,... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Cle... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClav... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port,... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Port... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotat... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿,... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clav... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced P... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clav... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotat... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way St... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Rem... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Conn... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-W... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿,... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Sto... Some devices were labeled as Does not contain DEHP even though the product may contain small am... 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.