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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
Sep 23, 2013 Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Ane... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Ane... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 Th... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesth... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-2... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 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.
Sep 23, 2013 Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional An... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesth... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 10, 2013 Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Ve... Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable V... Class II Smiths Medical ASD, Inc.
Sep 10, 2013 Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away S... Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable V... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, ... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Mar 28, 2013 Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product Code... Unable to pass catheter through outer sheath during embryo transfer Class II Smiths Medical ASD, Inc.
Mar 28, 2013 Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB6... Unable to pass catheter through outer sheath during embryo transfer Class II Smiths Medical ASD, Inc.
Mar 28, 2013 Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP... Unable to pass catheter through outer sheath during embryo transfer Class II Smiths Medical ASD, Inc.
Mar 28, 2013 Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasou... Unable to pass catheter through outer sheath during embryo transfer Class II Smiths Medical ASD, Inc.
Mar 28, 2013 Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product C... Unable to pass catheter through outer sheath during embryo transfer Class II Smiths Medical ASD, Inc.
Mar 28, 2013 Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfe... Unable to pass catheter through outer sheath during embryo transfer Class II Smiths Medical ASD, Inc.
Feb 6, 2013 Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Re... In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when use... Class I Smiths Medical ASD, Inc.
Jun 27, 2012 Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 ... HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , t... Class II Smiths Medical ASD, Inc.
Feb 14, 2012 Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Versio... Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that... Class I Smiths Medical ASD, Inc.
May 14, 2010 Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended ... An issue with the plunger rod seal was identified where the seal had the potential to migrate ins... 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.