Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jul 15, 2013 | Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Produc... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Nu... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These s... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43... | 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 DME) Catalog Number: 43523 Product... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Produ... | 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 Retail) Catalog Number: 43437 Prod... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 11, 2013 | LPS Lower Extremity Dovetail Intercalary component. Intended for use in re... | The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the fema... | Class I | DePuy Orthopaedics, Inc. |
| Jul 1, 2013 | MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an opti... | The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate v... | Class I | Iradimed Corporation |
| Jun 17, 2013 | Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 ... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 A... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 A... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboG... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 Alb... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, 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.