Z-1982-2023Class II

MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel

Name: Z-1982-2023 MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-05-03
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-05-03 / Open, Classified / root cause: sterility

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel on 2023-05-03. FDA classified it as Class II and gives the reason as "Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1982-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-03
Posted: 2023-06-21
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Product code: FRO Dressing, Wound, Drug
Reason for recall: Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Medline issued a recall notice to its consignees on 05/03/2023 by first calls mail and email The notice explained the problem with the device, risk and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product.2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-23-059 Recall Code: RXXXXXXX 3.Upon completion of the form, please destroy affected product. Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form."
Quantity in commerce: 851,328 units
Distribution: Worldwide distribution - US Nationwide and the countries of SINGAPORE, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, DUBAI, CHINA, PANAMA, CANADA, SAUDI ARABIA, BERMUDA, COLOMBIA, MAURITIUS, KUWAIT.
Product codes and lots: a) REF MNK0005: GTIN 30884389161566, Lot Numbers: LMPTH0189, LMPTH0191, LMPTH0193, LMPTH0195, LMPTH0197, LMPTH0199, LMPTH0201, LMPTH0203, LMPTH0205, LMPTH0207, LMPTH0211, LMPTH0213; b) REF MNK0015: GTIN 40884389154558, Lot Numbers: LMPTH0188, LMPTH0190, LMPTH0192, LMPTH0196, LMPTH0198, LMPTH0200, LMPTH0202, LMPTH0204, LMPTH0206, LMPTH0210, LMPTH0210B, LMPTH0212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1982-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1982-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21

Product code FRO

K131796UnclassifiedManuka Fill Wound DressingLinks Medical Products, Inc. / cleared 2014-03-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)