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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 6, 2020 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Rem... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Cla... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 1, 2020 REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClav... Incorrect filter assemblies in IV administration set. Class II ICU Medical, Inc.
Feb 14, 2020 The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; ... Firm identified software issues which leads to the patient ID and patient information not being s... Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Oct 4, 2019 REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-w... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, ... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hang... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, F... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Mani... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing,... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pr... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopco... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Jul 12, 2019 ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-00... Firm identified several software issues through internal testing of its Cogent Hemodynamic Monito... Class II ICU Medical, Inc.
Feb 21, 2019 icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Ad... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). ... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Gradu... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV admin... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV admini... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administr... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) ... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Jan 3, 2019 icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed Sy... There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate Class I ICU Medical, Inc.
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Oct 5, 2018 Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u... Potential for leakage due to defect in the thermoset check valve component. Class II ICU Medical, Inc.
Oct 5, 2018 Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per... Potential for leakage due to defect in the thermoset check valve component. Class II ICU Medical, Inc.
Oct 5, 2018 Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u... Potential for leakage due to defect in the thermoset check valve component. Class II ICU Medical, Inc.
Aug 20, 2018 ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF... Design change implemented changing the device from a blood set with a filter to a transfer set wi... Class II ICU Medical, Inc.
Feb 5, 2018 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer,... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouche... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotati... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Cla... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connect... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Jan 5, 2018 Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module ... When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pau... Class II ICU Medical, Inc.
Aug 31, 2017 SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 ... ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metal... Class II ICU Medical, Inc.
Jul 31, 2017 88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Ro... 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 159" (404 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.
Jul 31, 2017 119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blo... 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.