Browse Device Recalls
169 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 169 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 169 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 31, 2021 | Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Nu... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | Left Heart Kit, Model Number M20268. for blood pressure monitoring. | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 12... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Jan 18, 2021 | Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend... | Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless Fle... | Class II | Smiths Medical ASD Inc. |
| Dec 21, 2020 | Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use... | Shipping box may contain wrong model. | Class II | Smiths Medical ASD Inc. |
| Dec 15, 2020 | PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60P... | A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incor... | Class II | Smiths Medical ASD Inc. |
| Dec 8, 2020 | smiths medical portex Loss of Resistance Device, REF 100/398/000 | The labeling was missing information on sterilization and prohibition of reuse. | Class II | Smiths Medical ASD Inc. |
| Aug 28, 2020 | Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to... | Label has the incorrect size for the tracheotomy tube. | Class II | Smiths Medical ASD Inc. |
| Jul 14, 2020 | CADD Administration Sets, Model #21-7346-24 | Product may have been manufactured with an air filter assembled in an incorrect orientation. | Class II | Smiths Medical ASD Inc. |
| Jun 26, 2020 | Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump. | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific seque... | Class I | Smiths Medical ASD Inc. |
| Jun 26, 2020 | Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, ... | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific seque... | Class I | Smiths Medical ASD Inc. |
| Jun 11, 2020 | PORT-A-CATH¿ II POWER P.A.C. Low Profile" system. | Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System ... | Class II | Smiths Medical ASD Inc. |
| May 26, 2020 | Pediatric Adjustable Flange Tracheostomy Tube Cuffless | One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes wa... | Class II | Smiths Medical ASD Inc. |
| Mar 24, 2020 | CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L ... | Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. ... | Class I | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pre... | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091 | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model ... | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model... | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Mode... | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076 | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094 | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1... | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model... | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093 | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090 | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Mar 10, 2020 | smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092 | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... | Class II | Smiths Medical ASD Inc. |
| Feb 28, 2020 | Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product U... | Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid inf... | Class II | Smiths Medical ASD Inc. |
| Oct 28, 2019 | Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightwei... | There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially ... | Class I | Smiths Medical ASD Inc. |
| Jul 8, 2019 | GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled ... | Potential for certain GRIPPER Needles to contain an occluded or blocked needle. | Class II | Smiths Medical ASD Inc. |
| Jul 8, 2019 | GRIPPER Needles sold individually. Labeled as the following item description... | Potential for certain GRIPPER Needles to contain an occluded or blocked needle. | Class II | Smiths Medical ASD Inc. |
| Feb 11, 2019 | Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx... | Incorrect needle length and gage. | Class II | Smiths Medical ASD Inc. |
| Feb 11, 2019 | Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes in... | Packaged with an incorrect size inner cannula. | Class II | Smiths Medical ASD Inc. |
| Nov 26, 2018 | ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than in... | Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the saf... | Class II | Smiths Medical ASD Inc. |
| Nov 19, 2018 | Medex High Pressure Stopcock used to control the direction of IV fluid flow. ... | Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that m... | Class II | Smiths Medical ASD Inc. |
| Oct 15, 2018 | Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software... | Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured p... | Class II | Smiths Medical ASD Inc. |
| Aug 22, 2018 | Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Mode... | Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped punctur... | Class II | Smiths Medical ASD Inc. |
| 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. |
| Jul 6, 2018 | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Ti... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flare... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| 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. |
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.