Browse Device Recalls
3,164 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,164 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 3,164 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 23, 2017 | Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pou... | Possible open seal on top portion of the package. Could cause breach of sterility. | Class II | Medline Industries Inc |
| Oct 20, 2017 | HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx O... | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ... | Class II | Terumo BCT, Inc. |
| Oct 20, 2017 | Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat tr... | Potential breach of sterility of the packaging. | Class II | Shippert Medical Technologies |
| Oct 20, 2017 | HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice... | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ... | Class II | Terumo BCT, Inc. |
| Sep 18, 2017 | MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERIL... | The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead... | Class II | MicroPort Orthopedics Inc. |
| Sep 11, 2017 | BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and syn... | Cut resistant surgical glove liners lack sterility assurance. | Class II | Zimmer Biomet, Inc. |
| Sep 5, 2017 | Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline Prefilled 550 ml Sterile¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex Unit Dose 15 ml Normal Saline ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 35... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S ... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 24, 2017 | 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit C... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Jul 24, 2017 | Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | CVC Tray Pediatrics. Product Code: AMS-9335CP-2. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | 3-Way Standardbore Stopcock. Product Code: AMS-100. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic H... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Jul 24, 2017 | RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plas... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Jun 23, 2017 | Hypodermic Needle, 23 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Hypodermic Needle, 25 G X 5/8 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/case The product... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Hypodermic Needle, 20 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe, 30 CC L/S, 50 per box, 9 boxes/case, 450/case The products... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.5, 100 per box, 15 bo... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe, 60 CC L/L, 50 per box, 8 boxes/case, 400/case The products... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.0, 100 per box, 15 bo... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Hypodermic Needle, 30 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 bo... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe, 30 CC L/L, 50 per box, 9 boxes/case, 450/case The products... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Hypodermic Needle, 27 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.5, 100 per box, 24 bo... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.0, 100 per box, 15 bo... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, 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.