Medical Device Shortages List
Update: July 14, 2023
The FDA updated this web page to remove the following product codes from the shortages list:
- Specimen Collection – Testing Supplies and Equipment (product codes: JKA, GIM, and KXG)
- Laboratory Reagents and Testing Supplies – Testing Supplies & Equipment (product codes: QOF, JRC, LXG, PPM, NSU, OOI, and JJH)
- Transport Media Device - Testing Supplies & Equipment (product codes: LIO, QBD, and JSM)
- Saline, Vascular Access Flush – General ICU/ Hospital Products (product code: NGT)
- Certain Ventilation-Related Products - (product codes: BZD, MNT, and MNS)
The FDA also added information about the medical device removals from the shortage list on the Supply and Shortages of Medical Devices: Frequently Asked Questions.
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 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 Resilient Supply Chain Program (RSCP) 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:
- Anesthesiology
- Cardiovascular - Circulatory Support, Structural and Vascular Devices
- Cardiac Diagnostic and Monitoring Products
- Dialysis-Related Products
- General Hospital and Plastic Surgery Devices
- Radiological Devices
- Certain Ventilation-Related Products
| Category | Product Code (Description) | Availability and Estimated Shortage Duration2 | Additional Information | Reason for Interruption (per 506J) | Date (YYYY/MM/DD)3 |
|---|---|---|---|---|---|
| Cardiovascular - Circulatory Support, Structural and Vascular Devices | DSP (Intra-aortic Balloon and Control System) |
|
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 2023/01/20 Reverified |
| Anesthesiology - Ventilation-Related Products | JOH (Tube Tracheostomy and Tube Cuff) |
|
To provide recommendations to people who use these devices, the FDA is providing Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage: FDA Safety Communication |
|
2022/10/31 Initial 2023/01/26 Reverified |
| Anesthesiology - Ventilation-Related Products | BTO (Tube, Tracheostomy (w/wo Connector) |
|
To provide recommendations to people who use these devices, the FDA is providing Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage: FDA Safety Communication |
|
2022/10/31 Initial 2023/01/26 Reverified |
| Chest Drains with Autotransfusion Indications - General Hospital Devices | CAC (Apparatus, Autotransfusion) |
|
|
2022/07/19 Initial 2022/01/23 Reverified |
|
| Chest Drains and Suction Canisters - General Hospital Devices | KDQ (Bottle, Collection, Vacuum) |
|
|
2022/07/19 Initial 2023/01/23 Reverified |
|
| Cardiac Diagnostic and Monitoring Products | MKJ (Automated External Defibrillators (AEDs) (Non-Wearable)) |
|
|
2022/07/19 Initial 2022/12/06 Reverified 2023/03/16 Revised Estimated Duration |
|
| Cardiac Diagnostic, and Monitoring Products | MVK (Automated External Defibrillators (AEDs) (Wearable)) |
|
|
2022/07/19 Initial 2022/12/06 Reverified 2023/03/16 Revised Estimated Duration |
|
| Dialysis-Related Products | KDN (system, perfusion, kidney) |
|
|
2022/01/07 Initial 2023/01/26 Reverified |
|
| Dialysis‐Related Products | KDL (set, perfusion, kidney, disposable) |
|
|
2022/01/07 Initial 2023/01/26 Reverified |
|
| Ventilators - Ventilation-Related Products | NOU (Continuous ventilator, home use) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see Ventilators and Ventilator Accessories for COVID-19 FAQ). While there is currently limited supply available, public and private mitigations appear to be reducing constraints on the supply chain. |
|
2020/08/14 Initial 2022/12/01 Reverified 2023/03/16 Revised Estimated Duration |
| Ventilators - Ventilation-Related Products | CBK (Continuous ventilator, facility use) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see Ventilators and Ventilator Accessories for COVID-19 FAQ). While there is currently limited supply available, public and private mitigations appear to be reducing constraints on the supply chain. |
|
2020/08/14 Initial 2022/02/25 Revised 2022/12/01 Reverified |
1. The FDA has determined, pursuant to section 506J(g)(3)(C) of the FD&C Act (titled "Public Health Exception"), that disclosure of the manufacturer's name of the devices determined to be in shortage during a public health emergency will adversely affect the public health such as by increasing the potential for hoarding or other disruptions in device availability to patients.
2. Information on availability and estimated shortage duration is based on the FDA's current analysis and may change as the situation evolves.
3. The FDA has provided clarification in the "date" column regarding changes in information on the device shortages list.
- Initial: A device has been determined to be in shortage and added to the list
- Revised Estimated Duration: Change in the estimated duration of a device shortage
- Revised: Change in information to device already on the list (other than duration)
- Reverified: No change in the information; note this date reflects the most recent reverification and that interim verifications are not captured in the table
4. On December 23, 2020, the FDA updated the shortage list so that the description for product code PPM includes pipette tips, in addition to general purpose reagents and in vitro diagnostic tests.
5. The FDA is still compiling and evaluating data on manufacturing and production capacity and will update the list when more data are available.
6. On January 19, 2022, the FDA updated the shortage list so the description for product codes GIM and JKA includes all blood specimen collection tubes, in addition to the sodium citrate tubes already on the shortage list.
7. There is a global shortage of semiconductor chips. These computer chips are essential building blocks for many products, including certain medical devices. The FDA provides information about what the FDA is doing to help medical device manufacturers with the global shortage of semiconductor chips.
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 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:
- Clinical Chemistry Products
- General ICU/Hospital Products
- Infusion Pumps and Related Accessories
- Orthopedic
- Personal Protective Equipment
- Peritoneal Dialysis System and Accessories
- Sterilization Products
- Testing Supplies & Equipment
- Ventilation-Related Products
- Vital Sign Monitoring
| Category | Product Code | Manufacturer Name | Device Trade Name | Reason for Discontinuance | Date Posted (YYYY/MM/DD) |
|---|---|---|---|---|---|
| Automated External Defibrillators (AED) | 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 |
| Assisted Reproduction Labware - Testing Supplies & Equipment |
MQK (Labware, Assisted Reproduction) PUD (Labware, Assisted Reproduction, Exempt) |
Corning Incorporated |
|
Discontinuance of the manufacture of the device | 2023/06/08 |
| Clinical Chemistry Products | 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 |
| General ICU/ Hospital Products | LZC (Patient Examination Glove, Specialty) | Cardinal Health |
|
Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/10/31 |
| Anesthesiology - Ventilation-Related Products | BSZ (Anesthesia system- Ventilation- Related Product) | GE Healthcare |
|
Discontinuance of the manufacture of the device | 2022/10/31 |
| Needles and Syringes - General ICU/Hospital Products | GAA (Needle, Aspiration and Injection, Disposable) | Becton, Dickinson & Co. |
|
Discontinuance of the manufacture of the device | 2022/07/19 |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | 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 |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | 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 |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | 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 |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | QMC (Transport Medium, Notified Per The Vtm Guidance) | LaunchWorks CDMO |
|
Discontinuance of the manufacture of the device | 2022/07/19 |
| Specimen Collection - Testing Supplies & Equipment | JKA (Tubes, vials, systems, serum separators, blood collection) | ITL Asia Pacific Sdn. Bhd. |
|
Discontinuance of the manufacture of the device | 2022/07/19 |
| Surgical Apparel - Personal Protective Equipment | FXX (Mask, Surgical) | CHISON Medical Technologies Co., Ltd. |
|
Discontinuance of the manufacture of the device | 2022/07/19 |
| Surgical Apparel - Personal Protective Equipment | FXX (Mask, Surgical) | Huizhou Foryou Medical Devices Co., Ltd |
|
Discontinuance of the manufacture of the device | 2022/07/19 |
| Surgical Apparel - Personal Protective Equipment | FXX (Mask, Surgical) | Cardinal Health |
|
Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/07/19 |
| Gloves - Personal Protective Equipment | LZA (Polymer Patient Examination Glove) | Cardinal Health |
|
Discontinuance of the manufacture of the device | 2022/07/19 |
| General ICU/ Hospital Products | NGT (Saline, Vascular Access Flush) | Cardinal Health |
|
Discontinuance of the manufacture of the device |
2022/03/21 Initial 2023/01/20 Reverified 2023/03/16 Revised Estimated Duration |
| Surgical Apparel - Personal Protective Equipment | 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 |
| Surgical Apparel - Personal Protective Equipment | FXP (Cover, Shoe, Operating-Room) | Cardinal Health |
|
Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/03/21 |
| Surgical Apparel - Personal Protective Equipment | FXX (Mask, Surgical) | Cardinal Health |
|
Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/03/21 |
| Surgical Apparel - Personal Protective Equipment | FYF (Cap, Surgical) | Cardinal Health |
|
Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/03/21 |
| Surgical Apparel - Personal Protective Equipment | LYU (Accessory, Surgical Apparel) | Cardinal Health |
|
Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/03/21 |
| Surgical Apparel - Personal Protective Equipment | OEA (Non-Surgical Isolation Gown) |
|
Discontinuance of the manufacture of the device, alternatives are available for customers | 2022/03/21 | |
| Ventilation - Related Products | CAW (Generator, Oxygen, Portable) | Invacare Corporation |
|
Discontinuance of the manufacture of the device | 2023/03/16 |
| Vital Sign Monitoring | FLL (Thermometer, Electronic Clinical) | Philips Medizin Systeme Böblingen GmbH | Tympanic Temperature Module | Discontinuance of the manufacture of the device | 2021/11/23 |
| General ICU/Hospital Products | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | 20F PULL Ponsky:
|
Discontinuance of the manufacture of the device | 2021/05/04 |
| General ICU/Hospital Products | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | Ponsky Non-Balloon Replacement Tube | Discontinuance of the manufacture of the device | 2021/05/04 |
| General ICU/Hospital Products | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | 20F PUSH Ponsky
|
Discontinuance of the manufacture of the device | 2021/05/04 |
| General ICU/Hospital Products | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | Tri-Funnel Gastrostomy tube
|
Discontinuance of the manufacture of the device | 2021/05/04 |
| General ICU/Hospital Products | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | Jejunal Feeding/ Gastric Decompression tube
|
Discontinuance of the manufacture of the device | 2021/05/04 |
| General ICU/Hospital Products | KNT (Tubes, Gastrointestinal (and accessories)) | Bard Access Systems, Inc. | Dual Port Adapter
|
Discontinuance of the manufacture of the device | 2021/05/04 |
| General ICU/Hospital Products | KGC (Tube, Gastro-Enterostomy) | Bard Access Systems, Inc. | Button Gastrostomy tube Kit
|
Discontinuance of the manufacture of the device | 2021/05/04 |
| General ICU/Hospital Products | KGC (Tube, Gastro-Enterostomy) | Bard Access Systems, Inc. | Continuous Feeding Tube
|
Discontinuance of the manufacture of the device | 2021/05/04 |
| General ICU/Hospital Products | KGC (Tube, Gastro-Enterostomy) | Bard Access Systems, Inc. | Bolus Feeding Tube
|
Discontinuance of the manufacture of the device | 2021/05/04 |
| General ICU/Hospital Products | 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 |
| Needles and Syringes - General ICU/Hospital Products | GAA (Needle, Aspiration and Injection, Disposable) | Becton, Dickinson & Co. |
|
Discontinuance of the manufacture of the device | 2022/08/26 revised 2022/08/26 initial |
| Orthopedic | 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 |
| Oxygen Conserver - Ventilation-Related Product | 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 |
| Sterilization Products | 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 |
| Surgical Apparel - Personal Protective Equipment | FXX (Mask, Surgical) | Inno Foods Inc. | Mask, Surgical 3D | Discontinuance of the manufacture of the device | 2023/03/16 |
| Vital Sign Monitoring | 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 |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | 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 |
| Surgical Apparel - Personal Protective Equipment | 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 |
| Surgical Apparel - Personal Protective Equipment | FYF (Cap, Surgical) | Cardinal Health |
|
Discontinuance of the manufacture of the device, alternatives are available for customers | 2023/03/16 |
| Surgical Apparel - Personal Protective Equipment | LYU (Accessory, Surgical Apparel) | Inno Foods Inc. |
|
Discontinuance of the manufacture of the device | 2023/03/16 |
| Vital Sign Monitoring | MSX (Cardiac monitor, including cardiotachometer and rate alarm) | Philips Medical Systems | IntelliSpace Event Management | Discontinuance of the manufacture of the device | 2020/09/24 |
| Infusion Pumps and Related Accessories | 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 |
| Peritoneal Dialysis System and Accessories | 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 |
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.