Medical Device Shortages List
Update: December 4, 2024
The FDA updated this web page by adding the following product code to the shortage list:
- KPE (Container, I.V.)
The FDA publishes a device shortage list to provide transparency to the American public, particularly those who use or purchase medical devices. Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires the FDA to maintain a publicly available, up-to-date list of the devices determined to be in shortage. The medical device shortages list reflects the categories of devices the FDA has determined to be in shortage. The presence of a device type on this list does not necessarily indicate that patient care has been affected. In addition, the FDA provides a list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued.
The Office of Supply Chain Resilience is responsible for managing CDRH's activities to anticipate and prevent disruptions to the supply chain for medical devices, including managing the medical device shortage list.
On this page:
Related pages:
- Medical Device Supply Chain and Shortages
- Notify the FDA About an Interruption or Permanent Discontinuance in Device Manufacturing (506J Notification)
- Supply and Shortages of Medical Devices: Frequently Asked Questions
- Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health
- Notify the FDA About a Medical Device Supply Chain Issue
Device Shortage List
Categories of devices that are currently on the device shortage list1 are:
| Category | Product Code (Description) | Availability and Estimated Shortage Duration | Additional Information | Reason for Interruption (per 506J) | Date (YYYY/MM/DD) |
|---|---|---|---|---|---|
| Cardiovascular - Circulatory Support, Structural and Vascular Devices | DSP (Intra-aortic Balloon and Control System) | Estimated through Q4 2024. | To provide recommendations to health care providers and facilities who use these devices, the FDA is providing IABP Shortage - Letter to Health Care Providers |
| 2022/12/02 Initial 2024/04/26 Reverified |
| Cardiovascular - Circulatory Support, Structural and Vascular Devices | BYS (Oxygenator, Long Term Support Greater Than 6 Hours) | Estimated through Q4 2024. | Oxygenator devices intended for extracorporeal circulation are in shortage. |
| 2023/09/11 Initial 2024/10/02 Reverified |
| Cardiovascular - Circulatory Support, Structural and Vascular Devices | DTZ (Oxygenator, Cardiopulmonary Bypass) | Estimated through Q4 2024. | Oxygenator devices intended for extracorporeal circulation are in shortage. |
| 2023/09/11 Initial 2024/10/02 Reverified |
| Microbiology - Microbiology Devices | MDB (System, Blood Culturing) | Estimated through Q4 2024 | To provide recommendations to health care providers and laboratories that use blood culture media bottles intended for bloodstream infection testing, the FDA is providing a MDB Shortage - Letter to Health Care Providers. |
| 2024/07/10 Initial |
| General & Plastic Surgery - Surgical and Infection Control Devices | GEI (Electrosurgical, Cutting & Coagulation & Accessories) | Estimated through Q4 2024 | To provide recommendations to health care providers and facilities that use endoscopic vessel harvesting devices, the FDA is providing a Letter to Health Care Providers |
| 2024/11/15 |
| General Hospital - Drug Delivery and General Hospital Devices, and Human Factors | KPE (Container, I.V.) | Estimated through March 2025 | Empty I.V. bags of all sizes are in shortage. |
| 2024/12/04 |
1. The FDA is still compiling and evaluating data on manufacturing and production capacity and will update the list when more data are available.
Discontinuance List
As part of the list required to be established and maintained pursuant to section 506J(g) of the FD&C Act, the FDA is providing a separate, publicly available, up-to-date list of the devices that the FDA has been informed by the applicable manufacturer have been permanently discontinued. The FDA will update this list when it receives additional information regarding device discontinuances.
Categories of devices in the discontinuance list are:
- Anesthesiology
- Cardiovascular
- Clinical Chemistry
- Gastroenterology/Urology
- General & Plastic Surgery
- General Hospital
- Microbiology
- Obstetrics/Gynecology
- Orthopedic
- Radiology
| Category | Product Code | Manufacturer Name | Device Trade Name | Reason for Discontinuance | Date Posted (YYYY/MM/DD) |
|---|---|---|---|---|---|
| General Hospital – Drug Delivery and General Hospital Devices, and Human Factors Devices | FRN (Pump, Infusion) | Fresenius Kabi AG | Agilia Infusion Pump (Model: VOLUMAT MC AGILIA US, Product Code: Z021135) | Discontinuance of the manufacture of the device.
| 2024/07/10 |
| General & Plastic Surgery – General Surgery Devices | GEI (Electrosurgical, Cutting & Coagulation & Accessories) | Pro Med Instruments GmbH |
| Discontinuance of the manufacture of the device as of April 23, 2024. | 2024/07/10 |
| Obstetrics/Gynecology – Reproductive, Gynecology and Urology Devices | HEX (Colposcope (And Colpomicroscope)) | DYSIS Medical |
| Discontinuance of the manufacture of the device | 2024/07/10 |
| Obstetrics/Gynecology – Reproductive, Gynecology and Urology Devices | HDF (Speculum, Vaginal, Metal) | DYSIS Medical |
| Discontinuance of the manufacture of the device. | 2024/07/10 |
| Obstetrics/Gynecology – Reproductive, Gynecology and Urology Devices | HIB (Speculum, Vaginal, Nonmetal) | DYSIS Medical |
| Discontinuance of the manufacture of the device. | 2024/07/10 |
| Anesthesiology - Anesthesia, Respiratory, and Sleep Devices | BSZ (Anesthesia system- Ventilation- Related Product) | GE Healthcare |
| Discontinuance of the manufacture of the device | 2022/10/31 |
| Obstetrics/Gynecology - Reproductive, Gynecology, and Urology | MQK (Labware, Assisted Reproduction) PUD (Labware, Assisted Reproduction, Exempt) | Corning Incorporated |
| Discontinuance of the manufacture of the device | 2023/06/08 |
| Cardiovascular - Cardiac Electrophysiology, Diagnostics, and Monitoring | MKJ (Automated External Defibrillators) | Philips Medical Systems |
| Discontinuance of the manufacture of the device | 2024/07/10 |
| Cardiovascular - Cardiac Electrophysiology, Diagnostics, and Monitoring | MKJ (Automated External Defibrillators) | Stryker - Physio- Control, Inc. | LIFEPAK 20e defibrillator/ monitor:
| Discontinuance of the manufacture of the device, as of January 12, 2023, alternatives are available for customers. | 2023/06/08 |
| Clinical Chemistry - Chemistry and Toxicology Devices | NBW (System, Test, Blood Glucose, Over the Counter) | Abbott Diabetes Care Inc. |
| Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/10/31 |
| Radiology - Radiological Imaging and Radiation Therapy Devices | ITX (Transducer, Ultrasonic, Diagnostic) | SUPERSONIC IMAGINE | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (SKU: SSIP92029 & SSIP94000) | Discontinuance of the manufacture of the device. | 2024/04/26 |
| Radiology - Radiological Imaging and Radiation Therapy Devices | IYN (System, Imaging, Pulsed Doppler, Ultrasonic) | SUPERSONIC IMAGINE | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (SKU: SSIP92029 & SSIP94000) | Discontinuance of the manufacture of the device. | 2024/04/26 |
| Radiology - Radiological Imaging and Radiation Therapy Devices | IYO (System, Imaging, Pulsed Echo, Ultrasonic) | SUPERSONIC IMAGINE | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (SKU: SSIP92029 & SSIP94000) | Discontinuance of the manufacture of the device. | 2024/04/26 |
| Radiology - Radiological Imaging and Radiation Therapy Devices | LZC (Patient Examination Glove, Specialty) | Cardinal Health |
| Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/10/31 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | NGT (Saline, Vascular Access Flush) | Cardinal Health |
| Discontinuance of the manufacture of the device | 2022/03/21 |
| Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices | OAY | KARL STORZ |
| Discontinuance of the manufacture of the device. | 2023/12/18 |
| Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | 20F PULL Ponsky:
| Discontinuance of the manufacture of the device | 2021/05/04 |
| Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | Ponsky Non-Balloon Replacement Tube | Discontinuance of the manufacture of the device | 2021/05/04 |
| Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | 20F PUSH Ponsky
| Discontinuance of the manufacture of the device | 2021/05/04 |
| Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | Tri-Funnel Gastrostomy tube
| Discontinuance of the manufacture of the device | 2021/05/04 |
| Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | Jejunal Feeding/ Gastric Decompression tube
| Discontinuance of the manufacture of the device | 2021/05/04 |
| Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | Dual Port Adapter
| Discontinuance of the manufacture of the device | 2021/05/04 |
| Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices | KGC (Tube, Gastro-Enterostomy) | Bard Access Systems, Inc. | Button Gastrostomy tube Kit
| Discontinuance of the manufacture of the device | 2021/05/04 |
| Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices | KGC (Tube, Gastro-Enterostomy) | Bard Access Systems, Inc. | Continuous Feeding Tube
| Discontinuance of the manufacture of the device | 2021/05/04 |
| Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices | KGC (Tube, Gastro-Enterostomy) | Bard Access Systems, Inc. | Bolus Feeding Tube
| Discontinuance of the manufacture of the device | 2021/05/04 |
| Gastroenterology/Urology - Reproductive, Gynecology and Urology Devices | KGC (Tube, Gastro-Enterostomy) | Bard Access Systems, Inc. | Decompression Tube
| Discontinuance of the manufacture of the device Manufacturer has indicated that these will be offered through 9/30/2022. | 2021/05/04 |
| General & Plastic Surgery - General Surgery Devices | GCJ (Laparoscope, General & Plastic Surgery) | Vernacare Ltd. | NUBERT US New Bag for Endoscopic Retrieval of Tissue, 24003US | Discontinuance of the manufacture of the device. | 2024/02/19 |
| General & Plastic Surgery - General Surgery Devices | GCJ (Laparoscope, General & Plastic Surgery) | Vernacare Ltd. | NUBERT DS New Bag for Endoscopic Retrieval of Tissue (US only), 24003DS | Discontinuance of the manufacture of the device. | 2024/02/19 |
| General & Plastic Surgery - General Surgery Devices | GCJ (Laparoscope, General & Plastic Surgery) | Vernacare Ltd. | NUBERT Plus New Bag for Endoscopic Retrieval of Tissue, 24004 | Discontinuance of the manufacture of the device. | 2024/02/19 |
| General & Plastic Surgery - General Surgery Devices | GCJ (Laparoscope, General & Plastic Surgery) | Vernacare Ltd. | NUBERT DS Bag for Endoscopic Retrieval of Tissue (draw string bag), 24005 | Discontinuance of the manufacture of the device. | 2024/02/19 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | LZA (Polymer Patient Examination Glove) | Cardinal Health |
| Discontinuance of the manufacture of the device | 2022/07/19 |
| General Hospital - Drug Delivery and General Hospital Devices, and Human Factors | FRN (Infusion Pump) MEA (Infusion Pump, Patient Controlled Analgesic)) | Becton Dickinson and Company (CME America, LLC) | BodyGuard Infusion Pump System BodyGuard Syringe Pump System, BodyGuard microsets | Shortage or discontinuance of a component or part; Discontinuance of the manufacture of the device; Facility closure | 2020/08/14 |
| Microbiology - Microbiology Devices | JSM (Culture Media, Non-propagating) | Mediatech, Inc. | Viral Transport Media, 3 mL, Product 25-400-CRS | Discontinuance of the manufacture of the device | 2022/08/26 |
| Microbiology - Microbiology Devices | QMC (Transport Medium, Notified Per The Vtm Guidance) | Mediatech, Inc. | Corning Viral Transport Media, 3 mL, Product 25-501-CRS | Discontinuance of the manufacture of the device | 2022/08/26 |
| Clinical Chemistry - Chemistry and Toxicology Devices | LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use) | Kartell Spa |
| Discontinuance of the manufacture of the device | 2022/07/19 |
| Microbiology - Microbiology Devices | QMC (Transport Medium, Notified Per The Vtm Guidance) | LaunchWorks CDMO |
| Discontinuance of the manufacture of the device | 2022/07/19 |
| Clinical Chemistry - Chemistry and Toxicology Devices | NSU (Instrumentation for clinical multiplex test system) | BioFire Diagnostics, LLC | FilmArray Instrument (FLM1-ASY-0001) | Discontinuance of the manufacture of the device | 2021/01/22 |
| General & Plastic Surgery - General Surgery Devices | GAA (Needle, Aspiration and Injection, Disposable) | Becton, Dickinson & Co. |
| Discontinuance of the manufacture of the device | 2022/07/19 |
| General & Plastic Surgery - General Surgery Devices | GAA (Needle, Aspiration and Injection, Disposable) | Becton, Dickinson & Co. |
| Discontinuance of the manufacture of the device | 2022/08/26 |
| Orthopedic - Restorative, Repair and Trauma Devices | MOZ (Acid, Hyaluronic, Intraarticular) | Teva Pharmaceuticals USA, Inc. | Synojoynt (Sodium Hyaluronate 1% INJ 10mg/ml 3X2M)* | Discontinuance of the manufacture of the device | 2021/02/26 |
| Anesthesiology - Anesthesia, Respiratory, and Sleep Devices | NFB (Oxygen Conserver) | Inovo, Inc. | Single Lumen Conservers; Accupulse; Inovo, Inc. Accupulse Single Lumen Conserving Regulator Dual Lumen Conservers; Economizer; Inovo, Inc. Economizer Conserving Regulator | Discontinuance of the manufacture of the device | 2021/02/26 |
| Gastroenterology/Urology - Renal, Gastrointestinal, Obesity and Transplant Devices | FKO (Catheter, Peritoneal Dialysis, Single Use) | Becton Dickinson and Company (CareFusion 2200 Inc.) | Lazarus-Nelson Peritoneal Lavage Tray – LNT9000 | Discontinuance of the manufacture of the device | 2022/12/02 |
| Clinical Chemistry - Chemistry and Toxicology Devices | JKA (Tubes, vials, systems, serum separators, blood collection) | ITL Asia Pacific Sdn. Bhd. |
| Discontinuance of the manufacture of the device | 2022/07/19 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories) | Becton Dickinson and Company (ContainMed Inc.) | V. Mueller Horseshoe Retraction Kit Blades and Clamps Insert V. Mueller Horseshoe Retraction Kit Frames and Post Insert V. Mueller Universal Ring Retraction Set Blades and Rings Insert V. Mueller Universal Ring Retraction Set and Posts Insert | Discontinuance of the manufacture of the device | 2021/02/26 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | FXX (Mask, Surgical) | CHISON Medical Technologies Co., Ltd. |
| Discontinuance of the manufacture of the device | 2022/07/19 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | FXX (Mask, Surgical) | Huizhou Foryou Medical Devices Co., Ltd |
| Discontinuance of the manufacture of the device | 2022/07/19 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | FXX (Mask, Surgical) | Cardinal Health |
| Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/07/19 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | FME (Gown, Examination) | Cardinal Health | Gown Iso Polycoated, Knit Cuff, XL, White, 7301PG | Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/03/21 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | FXP (Cover, Shoe, Operating-Room) | Cardinal Health |
| Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/03/21 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | FXX (Mask, Surgical) | Cardinal Health |
| Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/03/21 |
| General & Plastic Surgery - General Surgery Devices | FYF (Cap, Surgical) | Cardinal Health |
| Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/03/21 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | LYU (Accessory, Surgical Apparel) | Cardinal Health |
| Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/03/21 |
| General Hospital - Drug Delivery and General Hospital Devices, and Human Factors | OEA (Non-Surgical Isolation Gown) |
| Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/03/21 | |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | FXX (Mask, Surgical) | Inno Foods Inc. | Mask, Surgical 3D | Discontinuance of the manufacture of the device | 2023/03/16 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | FXX (Surgical mask) | 3M Company | 3M Triple Layer Molded Face Mask (2042F), 3M Triple Layer Molded Face Mask, Petite (2042FP) | Discontinuance of the manufacture of the device | 2021/01/22 |
| General & Plastic Surgery - General Surgery Devices | FYF (Cap, Surgical) | Cardinal Health |
| Discontinuance of the manufacture of the device, alternatives are available for customers | 2023/03/16 |
| General Hospital - Infection Control and Plastic and Reconstructive Surgery | LYU (Accessory, Surgical Apparel) | Inno Foods Inc. |
| Discontinuance of the manufacture of the device | 2023/03/16 |
| Anesthesiology - Anesthesia, Respiratory, and Sleep Devices | CAW (Generator, Oxygen, Portable) | Invacare Corporation |
| Discontinuance of the manufacture of the device | 2023/03/16 |
| Cardiovascular - Circulatory Support, Structural and Vascular Devices | DSQ (Ventricular (Assist) Bypass) | Abbott Medical | HeartMate II™ Left Ventricular Assist System (Model/ Catalog Number)
| Discontinuance of the manufacture of the device as of December 31, 2026. Alternatives are available for customers. | 2023/12/18 |
| General Hospital - Drug Delivery and General Hospital Devices, and Human Factors | FLL (Thermometer, Electronic Clinical) | Philips Medizin Systeme Böblingen GmbH | Tympanic Temperature Module | Discontinuance of the manufacture of the device | 2021/11/23 |
| Cardiovascular - Cardiac Electrophysiology, Diagnostics, and Monitoring Devices | DSJ (Alarm, Blood-Pressure) | Philips Medical Systems | SureSigns VS4 NBP, SPO2 SureSigns VS4 U.S. Gov NBP, SPO2 SureSigns VS4 Government Bundle | Discontinuance of the manufacture of the device | 2021/02/26 |
| Cardiovascular - Cardiac Electrophysiology, Diagnostics, and Monitoring Devices | MSX (Cardiac monitor, including cardiotachometer and rate alarm) | Philips Medical Systems | IntelliSpace Event Management | Discontinuance of the manufacture of the device | 2020/09/24 |
| Clinical Chemistry - Chemistry and Toxicology Devices | NBW (System, Test, Blood Glucose, Over The Counter) | Intuity Medical, Inc | POGO Automatic Blood Glucose Monitoring System | Discontinuance of the manufacture of the device due to facility closure. | TBD |
| Clinical Chemistry - Chemistry and Toxicology Devices | NBW (System, Test, Blood Glucose, Over The Counter) | Intuity Medical, Inc | POGO Automatic Test Cartridges | Discontinuance of the manufacture of the device due to facility closure. | TBD |
| Clinical Chemistry - Chemistry and Toxicology Devices | JJX (Single (Specified) Analyte Controls (Assayed And Unassayed) | Intuity Medical, Inc | POGO Automatic Control Solution (Level 1) | Discontinuance of the manufacture of the device due to facility closure. | TBD |
| Clinical Chemistry - Chemistry and Toxicology Devices | JJX (Single (Specified) Analyte Controls (Assayed And Unassayed) | Intuity Medical, Inc | POGO Automatic Control Solution (Level 2) | Discontinuance of the manufacture of the device due to facility closure. | TBD |
| Clinical Chemistry - Chemistry and Toxicology Devices | JQP (Calculator/data Processing Module, for clinical use) | Intuity Medical, Inc | Patterns | Discontinuance of the manufacture of the device due to facility closure. | TBD |
| General Hospital - Drug Delivery and General Hospital Devices, and Human Factors | LZH (Pump, Infusion, Enteral) | Cardinal Health |
| Discontinuance of the manufacture of the device. | TBD |
| General Hospital - Drug Delivery and General Hospital Devices, and Human Factors | FOX (Stand, Infusion) | Cardinal Health |
| Discontinuance of the manufacture of the device. | TBD |
How the FDA Determines What Devices are in Shortage
For more information, see Supply and Shortages of Medical Devices: Frequently Asked Questions and Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health.