MEDLINE INDUSTRIES, LP Northfield Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.
Products Sold
Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.
MEDLINE INDUSTRIES, LP Northfield is recalling Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-St due to Surgical gowns were manufactured with the wrong sleeve.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Surgical gowns were manufactured with the wrong sleeve.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MD, OH, TN, TX, WI
Page updated: Jan 10, 2026