Surgical procedure kits recalled for elevated endotoxin levels
Medline surgical kits containing sterile surgical patties and strips have been recalled due to higher-than-expected endotoxin levels in raw materials. The affected supplies may pose a risk during sterile surgical procedures.
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 of surgical kit components with out-of-specification endotoxin contamination. Endotoxin in sterile surgical supplies poses a risk of infection during surgical procedures. No illnesses or injuries have been reported, placing this at the 'High' level per the rubric.
Plain-English summary
Medline Industries has recalled 22,970 custom convenience surgical kits containing sterile Codman surgical patties and strips. The kits were distributed nationwide in the United States and in Canada and are used in procedures including craniotomy, laminectomy, and spinal reconstruction.
Medline discovered that surgical patties and strips in specific lots of these kits contained higher-than-expected levels of endotoxin in the raw materials used for production, which may have resulted in out-of-specification endotoxin levels in the finished products. Endotoxin, a bacterial byproduct, can pose a risk during sterile surgical procedures if present in elevated levels.
Affected healthcare facilities should identify recalled kits using the product SKUs and lot numbers provided in the FDA recall notice. Kits should be removed from use and stored separately. Facilities should contact Medline Industries for replacement, refund, or disposal instructions.
No illnesses or injuries have been reported in connection with this recall. Healthcare providers should verify whether they have received affected product and take appropriate action based on the recall notice.
The recalled product
- Product
- Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS, SKU CDS981753K; 5) LAMINECTOMY CDS-LF, SKU CDS981923X; 6)…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical kits
- Affected units
- 22,970
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)
- UDI-DI: CDS780045N
- 10193489355406 (each)
- 40193489355407 (case)
- Lot Numbers: 22JBI816 22JBI817
- UDI-DI: CDS780119U
- 10193489371116 (each)
- 40193489371117 (case)
- UDI-DI: CDS780119V
- 10195327114916 (each)
- 40195327114917 (case)
- Lot Numbers: 22FBU189 22DBN874
- UDI-DI: CDS981753K
- 10193489848946 (each)
- 40193489848947 (case)
- Lot Numbers: 22DLA844
- UDI-DI: CDS981923X
- 10195327434298 (each)
- 40195327434299 (case)
- Lot Numbers: 23HBS882
- UDI-DI: CDS982719Q
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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 10 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 · endotoxin
See all →- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Craniotomy Kits Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighMedline surgical procedure kits recalled for non-sterile components and endotoxin contamination
FDA (Devices) · 2025-01-08
- HighMedline surgical procedure kits recalled for potential endotoxin contamination
FDA (Devices) · 2025-01-08
- HighMedline surgical procedure kits recalled for non-sterile supplies
FDA (Devices) · 2025-01-08
- HighMedline Custom Surgical Kits Recalled for Non-Sterile Components with Endotoxin Risk
FDA (Devices) · 2025-01-08
- HighMedline Medical Procedure Kits Recalled for High Endotoxin Levels
FDA (Devices) · 2026-05-06
- HighMedline Surgical Procedure Kits Recalled Due to Sterility Concerns
FDA (Devices) · 2025-01-08