BD GasPak™ EZ CO2 Gas Generating Pouch System 260684Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30382902606841), received between Apr 15, 2026 and Aug 11, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 7, 2026Class IIOpen, Classified

   BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

   Z-1982-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Device Ingredient or Reagent Problem

  It was reported that, while using the BD GasPak¿ EZ CO2 Gas Generating Pouch System, the customer observed that the indicator failed to change color within 4 hours for an unspecified number of patient samples. No patient impact, injury, or adverse health consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209933 ↗
• MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEM, THE CUSTOMER NOTICED THE SACHETS ARE INTERMITTENTLY FAILING TO GENERATE THE APPROPRIATE CO2 ENVIRONMENT ON UNSPECIFIED NUMBER OF PATIENT SAMPLES. HOWEVER, WHEN THE CUSTOMER TESTED A DIFFERENT LOT FROM A SISTER HOSPITAL, THE SACHETS WORKED AS EXPECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910863 ↗
• MalfunctionApr 15, 2026Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEM FOR PATIENT SAMPLES, THE SACHET FAILED TO BE PRODUCED, THE INDICATORS DID NOT CHANGE COLOR. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887368 ↗
• MalfunctionApr 15, 2026Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEM FOR PATIENT SAMPLES, THE SACHET FAILED TO BE PRODUCED, THE INDICATORS DID NOT CHANGE COLOR. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885952 ↗