Sterile Procedural Trays Recalled for Potential Blade Puncture
Medline sterile procedural trays for minor and breast biopsies are being recalled because sterile blades may puncture the outer foil packaging, compromising sterility. The recall affects 237 cases (1,242 units) 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: Per the severity rubric, this is a Class II medical device recall with no reported illnesses or injuries and a theoretical hazard (potential packaging puncture), meeting the criteria for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medline Industries, LP is recalling Sterile Procedural Trays, specifically Minor/Breast Biopsy-LF and Breast Biopsy-LF models. The recall involves 237 cases, containing 1,242 units total.
The recall was initiated because sterile blades within the trays have the potential to puncture the outer foil layer of the sterile packaging. If breached, the sterility of the medical contents cannot be guaranteed.
These trays have been distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. Healthcare facilities and providers who received these trays should verify whether they have stock with the affected lot numbers: 22IBK248, 22IBB171, 22HBM446, 22JBG862, or 22HBV267.
Affected trays should not be used for procedures. Healthcare providers should contact Medline Industries, LP for instructions regarding the return of affected inventory and replacement product.
The recalled product
- Product
- Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- blade-puncture
- sterile-field-compromise
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 (13)
- a. MINOR/BREAST BIOPSY-LF
- Item Number: DYNJS3035
- Case UDI/GTIN: 40884389421926
- Unit UDI/GTIN: 10884389421925
- Lot Number: 22IBK248
- 22IBB171
- 22HBM446
- b. BREAST BIOPSY-LF
- Item Number: DYNJT1911D
- Case UDI/GTIN: 40888277808967
- Unit UDI/GTIN: 10888277808966
- Lot Number: 22JBG862
- 22HBV267
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighPhilips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01