Z-1852-2021Class II

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638...

Name: Z-1852-2021 Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638...
Creator: Anodyne Surgical
Published: 2021-04-21
License: https://open.fda.gov/license/

Anodyne Surgical / initiated 2021-04-21 / Terminated / root cause: manufacturing process

FDA source

Anodyne Surgical began a recall of Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168... on 2021-04-21. FDA classified it as Class II and gives the reason as "The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1852-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-21
Posted: 2021-06-11
Terminated: 2022-05-27
Recalling firm: Anodyne Surgical
Product: Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300
Product code: HMX Cannula, Ophthalmic
Reason for recall: The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm initiated the recall by email on 04/21/2021. The letter explained the issue and requested the return of the product.
Quantity in commerce: 8452 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of IL, NJ, TX, MO, CA, PA, WA, and the country of Canada.
Product codes and lots: REF 7018, Lot Numbers: 201157-08 REF AS-7638, Lot Numbers: 210071-001, 210071-002 REF 7018NS, Lot Numbers: 210143-002 REF K20-3168, Lot Numbers:201108-005, 201108-017, 201108-018, 201154-007 REF 104910, Lot Numbers: 201144-002, 2010006-02, 210039-002, 210070-0001, 210080-01, 210127-001 REF CA7800, Lot Numbers: 201067-003, 201068-020 REF AX14784-BULK, Lot Numbers: 200580-006 REF RX2300NS, Lot Numbers: 200359-003 REF RX2300, Lot Numbers: 210142-002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1852-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1852-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-11

Product code HMX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)