Browse Device Recalls
3,629 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,629 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 3,629 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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 1, 2013 | GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe S... | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... | Class I | GE Healthcare, LLC |
| Oct 1, 2013 | GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: T... | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... | Class I | GE Healthcare, LLC |
| Oct 1, 2013 | GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-... | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... | Class I | GE Healthcare, LLC |
| Sep 30, 2013 | Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX0... | Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because... | Class I | Bard Peripheral Vascular Inc |
| Sep 30, 2013 | Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl I... | Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one c... | Class I | Merit Medical Systems, Inc. |
| Sep 23, 2013 | Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, st... | The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sh... | Class I | Baylis Medical Corp * |
| Sep 19, 2013 | Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology ... | Atossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Te... | Class I | Atossa Genetics, Inc. |
| Sep 19, 2013 | Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Dispos... | GE Healthcare has recently become aware of a potential safety issue due to air leakage associated... | Class I | GE Healthcare, LLC |
| Sep 16, 2013 | PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lowe... | PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding ... | Class I | Pentax Medical Company |
| Sep 16, 2013 | Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D,... | Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformat... | Class I | Edwards Lifesciences, LLC |
| Sep 16, 2013 | GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume ... | GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance ... | Class I | GE Healthcare, LLC |
| Sep 5, 2013 | Product Name: AVEA¿ Ventilator. All Models. The affected devices are clear... | CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher ... | Class I | Carefusion 211 Inc dba Carefusion |
| Aug 28, 2013 | GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Inte... | GE Healthcare has recently become aware of a potential safety issue involving unresponsive button... | Class I | GE Healthcare, LLC |
| Aug 27, 2013 | H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573... | Medical device tubing used for endotracheal airway application may become weakened and rendered i... | Class I | H & H Associates |
| Aug 21, 2013 | Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroSca... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2013 | Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2013 | Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: Micro... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2013 | MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: Mic... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2013 | Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Pro... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2013 | Microscan plus Negative Urine Combo 4 Sold outside of US only. Product ... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2013 | Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Syne... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2013 | Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2013 | Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: Mi... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2013 | Microscan plus Negative Combo 3 Sold outside of US only. Product Usage:... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2013 | Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: Mi... | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2013 | HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Indus... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., M... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product... | During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia mach... | Class I | Draeger Medical, Inc. |
| Aug 14, 2013 | CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., M... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., M... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., M... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., M... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries,... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline I... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries,... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industri... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, 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. |
| 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; 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 (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; 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 (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 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 Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Me... | Drug flow rates exceeding programmed flow rates. | Class I | Codman & Shurtleff, Inc. |
| Aug 7, 2013 | Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syrin... | Manufacturer made a change in the production process that resulted in a change in final gel weigh... | Class I | Enhancement Medical, LLC |
| Jul 15, 2013 | Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
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.