RegWardenFDA facility compliance records
Facility

JIANGSU SHENLI MEDICAL PRODUCTION CO.,LTD

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2024: 1 recalls, 1 inspections, 2 warning letters20172018201920202021202220234202420252026
  • Recalls (1)
  • Inspections (1)
  • Warning letters (2)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2024-04-05
    Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

FDA inspections (1)

  • OAI2024-03-29
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (2)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “JIANGSU SHENLI MEDICAL PRODUCTION CO.,LTD (FEI 3003902757) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003902757-jiangsu-shenli-medical-production-co-ltd/

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