FDA Recalls Syringe Tip Caps Due to Unapproved Device Modifications
Sol-Millennium Medical Inc. is recalling certain Syringe Tip Cap models because they were modified without proper FDA clearance. The modified devices differ from their approved specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is regulatory non-compliance—devices were modified without proper 510(k) clearance—making it a precautionary, compliance-driven recall rather than an active patient safety event.
Plain-English summary
Sol-Millennium Medical Inc. is recalling multiple Syringe Tip Cap models: SOL-M Syringe Tip Cap Blue (Model STCB01), SOL-M Syringe Tip Cap Red (Model STCB02), SOL-M Red Cap (Model 110101150020), and SOL-M Syringe Tip Cap Tray Black (Model STCT01). Specific lot numbers have been identified for each model.
The FDA determined that products in distribution were substantially different from the currently cleared 510(k) specifications with major modifications to the device's intended use. These modifications were made without proper FDA approval or clearance.
The affected products have been distributed nationwide in the United States and internationally to over 30 countries including Canada, Mexico, Australia, Brazil, and the United Kingdom.
Healthcare facilities and users should discontinue use of the affected products. Consult the manufacturer or FDA for guidance on product returns, replacements, or proper handling of existing inventory.
The recalled product
- Product
- Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
- Manufacturer
- Sol-Millennium Medical Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) Model No. STCB01
- UPC N/A
- LOT NUMBERS: 4201063
- 4209005
- 4307016
- 4308061
- 4311036
- 2) Model No. STCB02
- LOT NUMBERS: 4201064
- 3) Model No. 110101150020
- UPC N/A LOT NUMBERS: EXPIRED 4) Model No. STCT01
- UPC: Sole in Canada only
- LOT NUMBERS: 4301023
- 4308072
- 4308073
- 4309043
- 4310029
- 04311037
- 4312011
- 4312093
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Sol-Millennium Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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