GREER 1ml Allergenic Extract Mixing Syringe Tray 23G*1/2" GROM-23-2Recalls & reported problems
Sol-Millennium Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818392013795), received between May 16, 2025 and Apr 10, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Contamination1
- Crack1
- Device Slipped1
- Difficult to Fold, Unfold or Collapse1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Break; Crack
CUSTOMER REPORTED THAT THE OPTIMIX TWO SYRINGES (ITEM# GROM-23-2, LOT# 04204017), STATING THAT "DURING THE MIXING PROCESS THE SYRINGE POPPED OUT AND BROKE". THE CUSTOMER DID NOT PROVIDE ANY PHOTOGRAPHS AND THEY HAVE INDICATED THAT THEY DO NOT INTEND TO RETURN THE REPORTED PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843326 ↗MalfunctionMay 16, 2025Contamination; Contamination
"CUSTOMER REPORTED: WE RECEIVED A CUSTOMER COMPLAINT FOR 5 CASES OF OPTIMIX TWO SYRINGES (ITEM# GROM-23-2, LOT# 07212040), STATING THAT "A HAIR WAS FOUND ON THE SYRINGE ONCE IT WAS OPENED". THE CUSTOMER SENT THE ATTACHED PHOTOGRAPHS AND HAS INDICATED THAT THEY DO INTEND TO RETURN THE PRODUCT. CAN YOU PLEASE INITIATE AND INVESTIGATION AND FORWARD YOUR FINDINGS TO ME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035537 ↗MalfunctionMay 16, 2025Difficult to Fold, Unfold or Collapse; Device Slipped; Difficult to Fold, Unfold or Collapse; Device Slipped
"CUSTOMER REPORTED THAT WE RECEIVED A CUSTOMER COMPLAINT FOR OPTIMIX TWO SYRINGES (ITEM# GROM-23-2, LOT# 02407110), STATING THAT "THE SYRINGES WERE HARD TO USE". THE EXTRACT WAS HARD TO PULL UP INTO THE SYRINGE. THE CUSTOMER DID NOT PROVIDE ANY PHOTOGRAPHS, BUT THEY HAVE INDICATED THAT THEY INTEND TO RETURN THE PRODUCT. WE HAVE ASSIGNED THIS COMPLAINT NUMBER (B)(4)."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035491 ↗
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- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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