Medline Surgical Gowns Recalled for Manufacturing Defect in Sleeves
Medline is recalling 2,100 Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 surgical gowns because they were manufactured with the wrong sleeve. The affected gowns were distributed to healthcare facilities in Maryland, Ohio, Tennessee, Texas, and Wisconsin.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing defect in protective surgical gowns. While no illnesses or injuries have been reported in the source, the defect affects a critical component (sleeves) of a Level 4 protective gown, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 2,100 Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown) surgical gowns, Reference SPT-2208CS, from Lot #11023060120.
The gowns were manufactured with the wrong sleeve, constituting a manufacturing defect in these protective gowns.
The affected gowns were distributed to healthcare facilities in Maryland, Ohio, Tennessee, Texas, and Wisconsin. No government, military, or foreign distribution occurred.
The recalled product
- Product
- Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Protective Gown
- Hazard
- Affected units
- 2,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #11023060120
- UDI (01)40080196029755(11)230615(10)11023060120.
Distribution
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