Medical Device Shortages During the COVID-19 Public Health Emergency
March 17, 2022: The FDA published a Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health. The fact sheet includes additional information on the FDA’s medical device shortages authority and work on device shortages undertaken in the FDA’s Center for Devices and Radiological Health (CDRH), including actions and lessons learned during the COVID-19 public health emergency.
During the COVID-19 public health emergency, the FDA has taken many actions to help ensure that patients and health care providers have timely and continued access to high-quality medical devices to respond effectively. These actions include issuing Emergency Use Authorizations (EUAs) and guidance documents to provide recommendations and help expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 public health emergency.
The FDA publishes a device shortage list to provide transparency to the American public, particularly those who use or purchase medical devices. The list fulfills a statutory obligation under section 506J of the FD&C Act and reflects the categories of devices the FDA has determined to be in shortage at this time and will be maintained and updated as the COVID-19 public health emergency evolves. The presence of a device type on this list does not necessarily indicate that patient care has been affected.
For health care providers and other stakeholders seeking information on acquiring assets from the Strategic National Stockpile (SNS), refer to Requesting SNS Assets. Contact Regional Emergency Coordinators (RECs) for assistance to request personal protective equipment (PPE), ventilators, medical countermeasures, and federal medical station needs. For additional resources, see Supplies of Medical Devices for COVID-19: Frequently Asked Questions.
On this page:
- Device shortage list
- Device discontinuance list
- How the FDA determines what devices are in shortage
- Information on Section 506J of the FD&C Act
Related pages:
- Supplies of Medical Devices for COVID-19: Frequently Asked Questions
- Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health
- Medical Device Supply Chain Notifications During the COVID-19 Public Health Emergency
- Medical Device Types to Help Determine Section 506J Notification Obligations
- Contact the FDA About a Medical Device Supply Chain Issue
Device Shortage List
Categories of devices in the device shortage list1 are:
- Dialysis-Related Products
- Personal Protective Equipment
- Testing Supplies and Equipment
- Ventilation-Related Products
| Category | Product Code (Description) | Availability and Estimated Shortage Duration2 | Additional Information | Reason for Interruption (per 506J) | Date (YYYY/MM/DD)3 |
|---|---|---|---|---|---|
| General ICU/ Hospital Products | NGT (Saline, Vascular Access Flush) |
|
To mitigate ongoing shortages, the FDA is providing Prefilled Saline Flush Syringe Conservation Strategies. |
|
2022/03/21 |
| Dialysis-Related Products | KDN (system, perfusion, kidney ) |
|
|
2022/01/07 | |
| Dialysis‐Related Products | KDL (set, perfusion, kidney, disposable ) |
|
|
2022/01/07 | |
| Ventilators - Ventilation-Related Products | MNS (Ventilator, Continuous, Non-Life-Supporting) |
|
|
|
2021/09/10 Initial 2022/02/25 Reverified |
| Ventilators - Ventilation-Related Products | MNT (Ventilator, Continuous, Minimal Ventilatory Support, Facility Use) |
|
|
|
2021/09/10 Initial 2022/02/25 Reverified |
| Specimen Collection - Testing Supplies & Equipment | GIM (Tubes, vacuum sample, with anticoagulant) |
|
To mitigate ongoing shortages, the FDA is providing Blood Specimen Collection Tube Conservation Strategies. |
|
2021/06/10 Initial 2022/01/19 Revised6 2022/02/25 Reverified |
| Specimen Collection - Testing Supplies & Equipment | JKA (Tubes, vials, systems, serum separators, blood collection) |
|
To mitigate ongoing shortages, the FDA is providing Blood Specimen Collection Tube Conservation Strategies. |
|
2021/06/10 Initial 2022/01/19 Revised6 2022/02/25 Reverified |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ). | Demand increase for the device |
2021/05/24 Initial 2022/02/04 Reverified |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | JRC (Micro pipette) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ). |
Demand increase for the device |
2020/12/23 Initial 2022/02/04 Reverified |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | LXG (Equipment, laboratory, general purposes, labeled or promoted specifically for medical use, pipette tips only) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ). |
Demand increase for the device |
2020/12/23 Initial 2022/02/04 Reverified |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | PPM (General purpose reagents for in vitro diagnostic tests, including pipette tips4) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ). |
Demand increase for the device |
2020/08/14 Initial 2022/02/04 Reverified |
| Specimen Collection, Swab - Testing Supplies & Equipment | KXG (Absorbent tipped applicator) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ). |
Demand increase for the device |
2020/08/14 Initial 2022/02/04 Reverified |
| Transport Media Device - Testing Supplies & Equipment | JSM (Transport culture medium) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ). |
Demand increase for the device |
2020/08/14 Initial 2022/02/04 Reverified |
| Transport Media Device - Testing Supplies & Equipment | LIO (Microbiological specimen collection and transport device) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ). |
Demand increase for the device |
2020/08/14 Initial 2022/02/04 Reverified |
| Transport Media Device - Testing Supplies & Equipment | QBD (Microbial nucleic acid storage and stabilization device) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ). |
Demand increase for the device |
2020/08/14 Initial 2022/02/04 Reverified |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | JJH (Clinical sample concentrator) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ). |
Demand increase for the device |
2020/08/14 Initial 2022/02/04 Reverified |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | NSU (Instrumentation for clinical multiplex test system) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ). |
Demand increase for the device |
2020/08/14 Initial 2022/02/04 Reverified |
| Laboratory Reagents and Testing Supplies - Testing Supplies & Equipment | OOI (Real time nucleic acid amplification system) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see COVID-19 Testing Supplies FAQ). | Demand increase for the device |
2020/08/14 Initial 2022/02/04 Reverified |
| 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 |
| Ventilators - Ventilation-Related Products | BZD (Non-continuous ventilator) |
|
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 |
| 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. |
Demand increase for the device |
2020/08/14 Initial 2022/02/25 Reverified |
| Gloves - Personal Protective Equipment | LYY (Latex, non-powdered patient examination glove) |
|
To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Medical Gloves for COVID-19 FAQ). |
Demand increase for the device |
2020/08/14 2022/02/01 Reverified |
| Gloves - Personal Protective Equipment | LYZ (Vinyl patient examination glove) |
|
To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Medical Gloves for COVID-19 FAQ). |
Demand increase for the device |
2020/08/14 2022/02/01 Reverified |
| Gloves - Personal Protective Equipment | LZA (Polymer, non-powdered patient examination glove, includes nitrile gloves) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see Medical Gloves for COVID-19 FAQ). |
Demand increase for the device |
2020/08/14 Initial 2022/02/01 Reverified |
| Gloves - Personal Protective Equipment | LZC (Specialty, non-powdered patient examination glove, includes nitrile gloves) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see Medical Gloves for COVID-19 FAQ). |
Demand increase for the device |
2020/08/14 Initial 2022/02/01 Reverified |
| Gowns and Surgical Apparel - Personal Protective Equipment | FME (Examination gown) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers). |
Demand increase for the device |
2020/08/14 Initial 2022/02/01 Reverified |
| Gowns and Surgical Apparel - Personal Protective Equipment | FYA (Surgical gown) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers). |
Demand increase for the device |
2020/08/14 Initial 2022/02/01 Reverified |
| Gowns and Surgical Apparel - Personal Protective Equipment | OEA (Non-surgical isolation gown, Level 2 only) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers). |
Demand increase for the device |
2020/08/14 Initial 2022/02/01 Reverified |
| Surgical Apparel - Personal Protective Equipment | FXX (Surgical mask) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see Face Masks, Including Surgical Masks, and Respirators for COVID-19). |
Demand increase for the device |
2020/08/14 Initial 2022/02/01 Reverified |
| Surgical Apparel - Personal Protective Equipment | MSH (Surgical respirator) |
|
In an effort to mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see Face Masks, Including Surgical Masks, and Respirators for COVID-19). |
Demand increase for the device |
2020/08/14 Initial 2022/02/01 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 the COVID-19 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 COVID-19 Public Health Emergency 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: Change in information to device already on the list
- Reverified: No change in the information
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 is 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.
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:
- General ICU/Hospital Products
- Infusion Pumps and Related Accessories
- Orthopedic
- Personal Protective Equipment
- Sterilization Products
- Testing Supplies & Equipment
- Ventilation-Related Product – Oxygen Conserver
- Vital Sign Monitoring
| Category | Product Code | Manufacturer Name | Device Trade Name | Reason for Discontinuance | Date Posted (YYYY/MM/DD) |
|---|---|---|---|---|---|
| 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 | |
| General ICU/ Hospital Products | NGT (Saline, Vascular Access Flush) | Cardinal Health |
|
Discontinuance of the manufacture of the device | 2022/03/21 |
| 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 |
| 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 |
| Oxygen Conserver - Ventilation-Related Product | NFB (Oxygen Conserver) | Inovo, Inc. |
Single Lumen Conservers; Dual Lumen Conservers; |
Discontinuance of the manufacture of the device | 2021/02/26 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 Manufacturer has indicated that these will be offered through 9/30/2022. |
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 Manufacturer has indicated that these will be offered through 9/30/2022. |
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 Manufacturer has indicated that these will be offered through 9/30/2022. |
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 |
* Note: This device is not included as part of the table of device types and corresponding product codes that identifies devices that the FDA believes are critical to the public health during the COVID-19 PHE. This information was voluntarily provided by the manufacturer and has been posted to this list for transparency to assist stakeholders.
How the FDA Determines What Devices are in Shortage
For more information, see Supplies of Medical Devices for COVID-19: Frequently Asked Questions and Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health.
Information on Section 506J of the FD&C Act
On March 27, 2020, the CARES Act was signed into law. Section 3121 of the CARES Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 506J to the statute. Section 506J provides the FDA—for the first time—with authority intended to help prevent or mitigate medical device shortages "during, or in advance of, a public health emergency declared by the Secretary under section 319 of the PHS Act." The provision includes requirements for manufacturers of certain devices to notify the FDA "of a permanent discontinuance in the manufacture of the device" or "an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in supply of that device in the United States" during a declared public health emergency.
One provision of this new statutory authority—section 506J(g) of the FD&C Act—requires the FDA to establish and maintain a publicly-available, up-to-date list of the devices the FDA has determined to be in shortage. In addition, the FDA is providing a list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued.