CLASS IIONGOINGDevice recall · Reported 29 May 2024 · FDA Enforcement Report
Medline Syr L/l Red recalled by Jiangsu Shenli Medical
Jiangsu Shenli Medical Production is recalling Medline Syr L/l Red, distributed nationwide in the US. The recall was initiated on 5 Apr 2024 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codesLot Code: LOT: 63721010001,63721060001,63721070001,63721080001,63721090001,63721120001,63722010001, 63722050001,63722080002,63722100003,63723060001,63723070001,63723120002
Quantity recalled95200
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Product as listed by the FDA
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syringes without needles for single use Component: No
Where it was distributed
U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Which lots are affected?
Lot Code: LOT: 63721010001,63721060001,63721070001,63721080001,63721090001,63721120001,63722010001, 63722050001,63722080002,63722100003,63723060001,63723070001,63723120002
Where was it sold?
U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.