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.
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: 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…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 4,500
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.
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighSterile PVP Solution Kit Recalled for Non-Sterile Contents
FDA (Devices) · 2023-12-20
- HighMedline Sterile PVP Solution Recalled Due to Non-Sterile Contents
FDA (Devices) · 2023-12-20
- HighMedline PVP Solution Recalled Due to Mislabeled Sterility
FDA (Devices) · 2023-12-20
- HighSterile PVP Medical Solution Recalled for Non-Sterile Contents
FDA (Devices) · 2023-12-20
- HighMedline medical procedure kits recalled due to potential non-sterile packaging
FDA (Devices) · 2024-10-30
- HighMedline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk
FDA (Devices) · 2024-10-30