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Browse Device Recalls

125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 125 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 125 FDA device recalls.

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DateProductReasonClassFirm
Jul 13, 2018 Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase... The product was mislabeled with the incorrect label. 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.
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.
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 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.
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.
Oct 31, 2016 CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102... 20 Pumps sold to the Finnish market contain a message in which one word in the message is mistran... Class II Smiths Medical ASD, Inc.
Oct 31, 2016 HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotl... HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the requir... Class III Smiths Medical ASD, Inc.
Oct 25, 2016 NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reo... Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incor... Class II Smiths Medical ASD, Inc.
Jul 15, 2016 Custom Made Tracheostomy Device The CADD Administration Sets with Flow Sto... Smiths Medical determined that a single custom Tracheostomy device had been shipped to the custom... Class II Smiths Medical ASD, Inc.
Apr 22, 2016 CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-... Smiths Medical became aware that under delivery of medication may occur on CADD Administration Se... Class II Smiths Medical ASD, Inc.
Sep 14, 2015 PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF... The label on the lid stock of the individual needle packages for a portion of Lot number 46262 co... Class II Smiths Medical ASD, Inc.
May 26, 2015 CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Versio... Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the loc... 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
Mar 21, 2015 Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A. The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in... Class II Smiths Medical ASD, Inc.
Feb 2, 2015 CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Ster... Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette ... Class II Smiths Medical ASD, Inc.
Dec 17, 2014 Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Hep... The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit L... Class III Smiths Medical ASD, Inc.
Nov 21, 2014 Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock... Needle is not captured in the needle safety sheath in specific lots. Class II Smiths Medical ASD, Inc.
Nov 21, 2014 Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 ... Needle is not captured in the needle safety sheath in specific lots. Class II Smiths Medical ASD, Inc.
Nov 21, 2014 Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock... Needle is not captured in the needle safety sheath in specific lots. Class II Smiths Medical ASD, Inc.
Sep 29, 2014 CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-... Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD&quot... Class II Smiths Medical ASD, Inc.
Jul 7, 2014 H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediat... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric ... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediat... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Apr 22, 2014 SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with t... The hose could separate from the blanket. Class II Smiths Medical ASD, Inc.
Apr 10, 2014 Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The c... One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in... Class I Smiths Medical ASD, Inc.
Mar 17, 2014 Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended f... Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the ... Class II Smiths Medical ASD, Inc.
Mar 17, 2014 Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended... Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the ... Class II Smiths Medical ASD, Inc.
Nov 22, 2013 4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. p... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. ... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 2... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pu... Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smi... Class II Smiths Medical ASD, Inc.
Nov 22, 2013 G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. p... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. pe... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. pe... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. p... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. pe... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. ... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. pe... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentrati... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. p... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Nov 22, 2013 4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per... issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthe... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... 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.