Z-0711-2024Class II

Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile

Name: Z-0711-2024 Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-11-29
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-11-29 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile on 2023-11-29. FDA classified it as Class II and gives the reason as "Surgical gowns were manufactured with the wrong sleeve". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0711-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-29
Posted: 2024-01-11
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Product code: FYA Gown, Surgical
Reason for recall: Surgical gowns were manufactured with the wrong sleeve.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued letters dated 11/29/2023 via email and first class mail on 11/29/2023. The letter explained the reason for recall and provided required actions. Those actions were to (1) Immediately check the stock for the affected item and lot numbers which can be located within the recall portal; (2) Use the link and information in the letter to complete the response form; and (3) Destroy any affected inventory and the recalling firm will issue a credit. If the consignee is a distributor or has resold or transferred the product to another company or individual, the consignee is to notify the downstream company.
Quantity in commerce: 2,100 gowns
Distribution: Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
Product codes and lots: Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0711-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0711-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-11

Product code FYA

K182172Class IIMedline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)Medline Industries, Inc. / cleared 2019-04-24

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)