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Browse Device Recalls

179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 179 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 179 FDA device recalls.

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DateProductReasonClassFirm
Jul 6, 2018 smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Fl... "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... Class III Smiths Medical ASD Inc.
Jun 22, 2018 Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial B... The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain th... Class II Smiths Medical ASD Inc.
Jun 22, 2018 Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial B... The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain th... Class II Smiths Medical ASD Inc.
May 10, 2018 medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 0... Product has a lack of sterility assurance Class II Smiths Medical ASD Inc.
Apr 13, 2018 Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, r... Class II Smiths Medical ASD Inc.
Apr 2, 2018 Bivona¿ Tracheostomy Tube Tracheostomy Tubes Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as s... Class II Smiths Medical ASD Inc.
Dec 4, 2017 Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM... Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kit... Class II Smiths Medical ASD Inc.
Dec 4, 2017 PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM... Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kit... Class II Smiths Medical ASD Inc.
Nov 29, 2017 BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 92065... Some printing modes on the devices may not function properly (tabular data printing, real-time co... Class II Smiths Medical ASD Inc.
Nov 22, 2017 CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 100085... Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The la... Class II Smiths Medical ASD Inc.
Nov 13, 2017 Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps a... Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misi... Class II Smiths Medical ASD Inc.
Nov 13, 2017 Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps a... Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misi... Class II Smiths Medical ASD Inc.
Nov 13, 2017 Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps a... Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misi... Class II Smiths Medical ASD Inc.
Sep 25, 2017 CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. No... Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may... Class II Smiths Medical ASD Inc.
Sep 25, 2017 CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented ... Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may... Class II Smiths Medical ASD Inc.
Sep 25, 2017 CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvente... Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may... Class II Smiths Medical ASD Inc.
Aug 24, 2017 Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient contr... In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not matc... Class II Smiths Medical ASD Inc.
Aug 22, 2017 Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactu... Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... Class II Smiths Medical ASD Inc.
Aug 22, 2017 Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufacture... Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... Class II Smiths Medical ASD Inc.
Aug 14, 2017 UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/08... Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy T... Class II Smiths Medical ASD Inc.
Jun 5, 2017 CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented... The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been... Class II Smiths Medical ASD Inc.
May 15, 2017 CADD¿ High Volume Administration Set with FlowStop, 21-7381-24. Product U... One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, inco... Class II Smiths Medical ASD Inc.
Apr 4, 2017 Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 &... Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medica... Class II Smiths Medical ASD Inc.
Mar 17, 2017 CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO. Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yel... Class II Smiths Medical ASD Inc.
Feb 9, 2017 Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, ... Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy ... Class II Smiths Medical ASD Inc.
Dec 9, 2016 Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Steri... The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is co... Class II Smiths Medical ASD Inc.
Nov 21, 2016 Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvan... Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720... Class II Smiths Medical ASD Inc.
Dec 3, 2015 Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3... There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Al... Class II Smiths Medical ASD Inc.
May 4, 2015 Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID P... Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Se... Class II Smiths Medical Asd 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.