FDA Device recall Z-2099-2024

Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needle…

FDA Device
Class II
ongoing
Published 2024-05-29

On 2024-05-29 the FDA classified a Class II recall of Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needle… by Jiangsu Shenli Medical Production, citing piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2099-2024
Classification	Class II
Status	ongoing
Initiated	2024-04-05
Published	2024-05-29
Last updated	2026-09-13 11:57 UTC
Company	Jiangsu Shenli Medical Production
Distribution	US

Product

Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needles for single use Component: No

Reason

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Identifiers

code_info	Lot Code: LOT: 63721010001,63721010003,63721040002,63721050 002,63721060001,63721070001,63721070002, 63721070003,637210… Lot Code: LOT: 63721010001,63721010003,63721040002,63721050 002,63721060001,63721070001,63721070002, 63721070003,63721070004,63721070006,63721080 001,63721080002,63721080003,63721080004, 63721080005,63721090001,63721090003,63721090 004,63721090005,63721100001,63721110001, 63721110002,63721110003,63721120002,63721120 003,63721120004,63722010001,63722020002, 63722030001,63722030002,63722030003,63722030 004,63722040002,63722040004,63722050001, 63722050002,63722050003,63722060002,63722060003,63722060006,63722070002,63722070004, 63722070005,63722070006,63722080003,63722080 005,63722080006,63722090003,63722100003, 63722120003,63722120004,63723010001,63723020 001,63723020002,63723050001,63723060001, 63723070001,63723070002,63723070003,63723080 002,63723080003,63723090002,63723090003, 63723090004,63723100003,63723100004,63723110 001,63723110003,63723120002

code_info

Lot Code: LOT: 63721010001,63721010003,63721040002,63721050 002,63721060001,63721070001,63721070002, 63721070003,637210…

Lot Code: LOT: 63721010001,63721010003,63721040002,63721050 002,63721060001,63721070001,63721070002, 63721070003,63721070004,63721070006,63721080 001,63721080002,63721080003,63721080004, 63721080005,63721090001,63721090003,63721090 004,63721090005,63721100001,63721110001, 63721110002,63721110003,63721120002,63721120 003,63721120004,63722010001,63722020002, 63722030001,63722030002,63722030003,63722030 004,63722040002,63722040004,63722050001, 63722050002,63722050003,63722060002,63722060003,63722060006,63722070002,63722070004, 63722070005,63722070006,63722080003,63722080 005,63722080006,63722090003,63722100003, 63722120003,63722120004,63723010001,63723020 001,63723020002,63723050001,63723060001, 63723070001,63723070002,63723070003,63723080 002,63723080003,63723090002,63723090003, 63723090004,63723100003,63723100004,63723110 001,63723110003,63723120002

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2099-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.