Home / Recalls / Jiangsu Shenli Medical Production Co., Ltd. / Z-2099-2024

Z-2099-2024 Class II Ongoing

Recalled by Jiangsu Shenli Medical Production Co., Ltd. — Changzhou

FDA device recall Z-2099-2024 was initiated by Jiangsu Shenli Medical Production Co., Ltd. on Apr 5, 2024 and is designated Class II. Reason for recall: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). The recall status is ongoing. Affected quantity: 9050240.

Recall Details

Product Type
Devices
Report Date
May 29, 2024
Initiation Date
Apr 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9050240

Product Description

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 for Recall

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

Distribution Pattern

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.

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2099-2024
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Jiangsu Shenli Medical Production Co., Ltd.

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  • Z-2114-2024 Class II — Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number… (Apr 5, 2024)
  • Z-2065-2024 Class II — Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number… (Apr 5, 2024)
  • Z-2106-2024 Class II — Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE… (Apr 5, 2024)
  • Z-2127-2024 Class II — Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog… (Apr 5, 2024)
  • Z-2069-2024 Class II — Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number… (Apr 5, 2024)
  • Z-2087-2024 Class II — Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog… (Apr 5, 2024)
  • Z-2045-2024 Class II — Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080… (Apr 5, 2024)
  • Z-2082-2024 Class II — Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog… (Apr 5, 2024)
  • Z-2056-2024 Class II — Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822… (Apr 5, 2024)

FDA data resources