Medline Pre-Op CHG Bathing Kit recalled for incorrect expiration dates
Medline is recalling 460 Pre-Op CHG Bathing Kits because the CHG solution and blood culture bottles have expiration dates that don't match the kit label. Expired components could compromise effectiveness.
What this means for you
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 a Class II medical device recall involving mislabeled expiration dates on critical components. Expired CHG solution and blood culture bottles could fail to function properly in pre-operative and specimen collection procedures. No adverse events are mentioned, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling the Pre-Op CHG Bathing Kit (Reorder #P164756) due to mismatched expiration dates on kit components. The CHG (chlorhexidine gluconate) solution and Bactec blood culture bottles included in the kit have expiration dates that do not match the date listed on the kit label.
Using expired components in medical procedures poses a safety concern. CHG solution loses antimicrobial effectiveness over time, and blood culture bottles may no longer maintain proper sterility. Healthcare providers who rely on the incorrect expiration date could inadvertently use expired products, potentially compromising the safety and effectiveness of pre-operative skin preparation and blood sample collection.
The recall affects 460 kits with lot numbers 22EMI516 and 22DMG491, distributed nationwide in California.
If you have been provided one of the affected kits, stop using it and contact Medline Industries for return or replacement instructions.
The recalled product
- Product
- MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- mis-labeling
- expired-component
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 (4)
- UDI/DI: (01)40888277983824 (case)
- (01)10888277983823 (kit)
- Lot Numbers: 22EMI516
- 22DMG491
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01