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Browse Device Recalls

58 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 58 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 58 FDA device recalls.

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DateProductReasonClassFirm
Nov 10, 2015 MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The Med... A small number of specific pumps may trigger a low battery alarm at the beginning of the implante... Class II Codman & Shurtleff, Inc.
Nov 10, 2015 MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The Med... A small number of specific pumps may trigger a low battery alarm at the beginning of the implante... Class II Codman & Shurtleff, Inc.
Mar 5, 2015 CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the C... Needle is leaking from hub/needle cannula connection Class II Codman & Shurtleff, Inc.
Sep 15, 2014 Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage Sys... tubing within the system that drains CSF may leak or disconnect from the joints and may result in... Class II Codman & Shurtleff, Inc.
Sep 15, 2014 Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage Sy... tubing within the system that drains CSF may leak or disconnect from the joints and may result in... Class II Codman & Shurtleff, Inc.
Sep 15, 2014 Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System)... tubing within the system that drains CSF may leak or disconnect from the joints and may result in... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessori... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessor... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 8... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ C... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Access... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Cert... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Dec 13, 2013 CODMAN CERTAS Programmable Valves, central nervous system shunt, models as fo... Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray im... Class II Codman & Shurtleff, Inc.
Oct 11, 2013 TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes ... Incorrect instructions for use (IFU). Class I Codman & Shurtleff, Inc.
Oct 11, 2013 TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube o... Incorrect instructions for use (IFU). Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Me... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstrea... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstrea... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream progra... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programma... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Me... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Jun 7, 2013 MedStream Programmable Infusion Pump , Implantable for the intrathecal delive... Miscalibrated Fill Level Sensor may affect dosing level Class I Codman & Shurtleff, Inc.
Jun 7, 2013 MedStream Programmable Infusion Pump- Implantable for the intrathecal deliver... Miscalibrated Fill Level Sensor may affect dosing level Class I Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Catheter and Accessories ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Cathe... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Uniti... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Cat... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Cathet... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for u... Sterility of device may be compromised due to lack of packaging integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, 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.