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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 27, 2024 | CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the foll... | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... | Class I | Smiths Medical ASD Inc. |
| Feb 27, 2024 | CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following ... | CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following ... | Class I | Smiths Medical ASD Inc. |
| Feb 27, 2024 | CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, a... | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... | Class I | Smiths Medical ASD Inc. |
| Feb 7, 2024 | smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP,... | When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... | Class I | Smiths Medical ASD Inc. |
| Feb 7, 2024 | smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, RE... | When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... | Class I | Smiths Medical ASD Inc. |
| Dec 19, 2023 | Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medf... | Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... | Class II | Smiths Medical ASD Inc. |
| Dec 19, 2023 | Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 ... | Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... | Class II | Smiths Medical ASD Inc. |
| Dec 19, 2023 | Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 | Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... | Class II | Smiths Medical ASD Inc. |
| Dec 19, 2023 | smiths medical Medfusion Model 4000 syringe pump | Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the f... | Class I | Smiths Medical ASD Inc. |
| Dec 19, 2023 | Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-01... | Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... | Class II | Smiths Medical ASD Inc. |
| Dec 19, 2023 | smiths medical Medfusion Model 3500 Syringe pump | Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. D... | Class I | Smiths Medical ASD Inc. |
| Nov 10, 2023 | Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R | There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... | Class II | Smiths Medical Asd Inc |
| Nov 10, 2023 | 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR | There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... | Class II | Smiths Medical Asd Inc |
| Nov 10, 2023 | Medex LOGICAL CATH LAB KIT, List Number M20754 | There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... | Class II | Smiths Medical Asd Inc |
| Nov 10, 2023 | 6IN PRESSURE TUBING, List Number MX20617 | There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... | Class II | Smiths Medical Asd Inc |
| Nov 10, 2023 | HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP | There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... | Class II | Smiths Medical Asd Inc |
| Nov 10, 2023 | HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP | There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... | Class II | Smiths Medical Asd Inc |
| Nov 10, 2023 | 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL | There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... | Class II | Smiths Medical Asd Inc |
| Nov 10, 2023 | Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R | There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... | Class II | Smiths Medical Asd Inc |
| Nov 10, 2023 | 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R | There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... | Class II | Smiths Medical Asd Inc |
| Sep 6, 2023 | Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase... | The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the pa... | Class II | Smiths Medical ASD Inc. |
| Aug 22, 2023 | Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P... | The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) b... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on... | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) ... | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0... | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Jul 18, 2023 | PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter | Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflectin... | Class II | Smiths Medical ASD Inc. |
| Apr 5, 2023 | DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product ... | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequat... | Class II | Smiths Medical ASD Inc. |
| Apr 5, 2023 | DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product ... | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequat... | Class II | Smiths Medical ASD Inc. |
| Apr 5, 2023 | DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code... | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequat... | Class II | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Oct 10, 2022 | Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or ... | Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record sy... | Class II | Smiths Medical ASD Inc. |
| Apr 18, 2022 | Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model... | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... | Class I | Smiths Medical ASD Inc. |
| Apr 18, 2022 | Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-2... | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... | Class I | Smiths Medical ASD Inc. |
| Aug 9, 2021 | Bivona Uncuffed Wire Endotracheal Tubes, | Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of... | Class II | Smiths Medical ASD Inc. |
| Aug 9, 2021 | Bivona Aire-Cuf Endotracheal Tube | Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of... | Class II | Smiths Medical ASD Inc. |
| Aug 6, 2021 | NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 | There is potential for harmful levels of aluminum leaching when using lower flow rates with certa... | Class I | Smiths Medical ASD Inc. |
| Aug 6, 2021 | NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR... | There is potential for harmful levels of aluminum leaching when using lower flow rates with certa... | Class I | Smiths Medical ASD Inc. |
| Aug 4, 2021 | smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X... | The incorrect device is contained in the package. | Class II | Smiths Medical ASD Inc. |
| Jul 15, 2021 | Pneupac paraPac plus 300 ventilator kit, REF P300NGB | Two devices were labeled with the same serial number | Class III | Smiths Medical ASD Inc. |
| May 17, 2021 | JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2... | Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 2... | Class I | Smiths Medical ASD Inc. |
| May 14, 2021 | PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Pr... | One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and b... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | Palm Cups - Product Usage: intended to be used to percuss the chest wall to m... | The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot... | 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.