RegWardenFDA facility compliance records
Facility

CHEMLINK LABORATORIES, LLC.

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2015: 1 recalls; 2016: 2 recalls; 2017: 2 recalls; 2018: 1 recalls; 2021: 1 recalls1’13’141’152’162’171’18’19’201’21’22’23’24’25’26
  • Recalls (8)

Devices registered here (1)

  • Cleaner, Ultrasonic, Medical Instrument
    Product code FLG (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6150

Recalls & enforcement

  • Class IITerminated2021-01-11
    Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to prevent further recurrence. The slits may lead to a breach in the sterile barrier between fl…
  • Class IITerminated2018-09-14
    The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.
  • Class IIITerminated2017-11-22
    The incorrect IFU was shipped with the product.
  • Class IITerminated2017-10-13
    Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
  • Class IIITerminated2016-11-30
    The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was ina…
  • Class IITerminated2016-07-14
    Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.
  • Class IITerminated2015-08-18
    The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure.
  • Class IITerminated2013-07-02
    Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

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. “CHEMLINK LABORATORIES, LLC. (FEI 1000158594) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000158594-chemlink-laboratories-llc/

Not open yet

Alerts for CHEMLINK LABORATORIES, LLC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.