Sterile arthroscopy trays recalled for potential blade puncture risk
Medline Industries recalls multiple sterile arthroscopy surgical trays because blades in the kits may puncture the outer foil packaging, potentially compromising sterility. Affected products were distributed worldwide.
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 FDA Class II recall involves sterile surgical instruments used in invasive orthopedic procedures. Although no adverse events have been reported, the potential for blade puncture to compromise packaging sterility creates a significant risk of surgical site infection, meeting the criterion for high-severity risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling multiple sterile arthroscopy and arthrotomy surgical procedure trays. The recalled kits are distributed under various product names and include numerous variants used in orthopedic surgery. Approximately 1,419 cases containing 4,349 units are affected by this recall.
The recall was initiated because the sterile blades contained within these surgical kits have the potential to puncture the outer foil layer of the sterile packaging. If the packaging is compromised, the sterility of the surgical instruments may be affected.
These products were distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. Specific lot numbers and item numbers are provided to identify affected products.
Healthcare facilities that have received these products should verify their inventory using the provided lot numbers and item numbers to identify any affected trays. Organizations should contact Medline Industries or consult FDA guidance for instructions on managing recalled inventory.
The recalled product
- Product
- Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- packaging-puncture
- sterility-loss
- contamination-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. KNEE ARTHROSCOPY CDS-LF
- Item Number: CDS940869U
- Case UDI/GTIN: 40195327210046
- Unit UDI/GTIN: 10195327210045
- Lot Number: 22JBR468
- 22JBA443
- b. ARTHROSCOPY CDS
- Item Number: CDS985208B
- Case UDI/GTIN: 40889942942061
- Unit UDI/GTIN: 10889942942060
- Lot Number: 22JBR379
- 22IBS410
- 22IBO331
- 22IBO332
- c. ARTHROSCOPY LV - EDOC PACK-LF
- Item Number: DYNJ0111409L
- Case UDI/GTIN: 40889942824015
- Unit UDI/GTIN: 10889942824014
- Lot Number: 22JMH535
- 22IMF440
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedical Device Surgical Kits with Syringes 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
- ModerateMedline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01