Medline Non-Sterile PVP Surgical Solution Kits Mislabeled as Sterile
Medline is recalling 4,500 surgical kits because the non-sterile PVP solution inside was mislabeled as sterile. Using the mislabeled product in sterile surgical procedures could introduce non-sterile materials into surgical fields.
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: The mislabeling of non-sterile PVP solution as sterile in surgical kits creates a significant risk of surgical site contamination and infection. No illnesses or injuries have been reported, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 4,500 units of non-sterile PVP solution packaged in 43 different surgical kit configurations used for orthopedic procedures, including total joint, total knee, hip arthroplasty, and related surgical packs. These kits have been distributed worldwide, including throughout the United States and Panama.
The affected products were mislabeled as "STERILE PVP SLN" when they should have been labeled "NON-STERILE PVP SOLUTION, STERILE PACKAGING." This labeling error creates a risk that healthcare providers using the kits may unknowingly introduce non-sterile materials into sterile surgical fields, potentially compromising the sterility of surgical procedures.
Healthcare facilities that received affected kits should verify their inventory against the provided lot numbers and model numbers. Those with affected products should discontinue use immediately and contact Medline Industries for instructions on return or destruction of the mislabeled kits. Patients who underwent orthopedic surgical procedures using the affected kits should contact their healthcare provider if they experience signs of surgical site infection.
The recalled product
- Product
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- mis-labeling
- infection-risk
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 (20)
- a) Model Number CDS985555S
- UDI/DI (EA) 10195327343798
- UDI/DI (CS) 40195327343799
- Lot Numbers: 23EBK088
- b) Model Number CDS985566Q
- UDI/DI (EA) 10195327074418
- UDI/DI (CS) 40195327074419
- Lot Numbers: 23EBT802
- c) Model Number DYNJ0949139I
- UDI/DI (EA) 10195327195366
- UDI/DI (CS) 40195327195367
- Lot Numbers: 23DBP964
- 23CBU228
- d) Model Number DYNJ24525K
- UDI/DI (EA) 10195327135751
- UDI/DI (CS) 40195327135752
- Lot Numbers: 23EBT909
- 23EBG098
- 23DBB838
- e) Model Number DYNJ24526P
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27