Medline Surgical Kits Recalled for Incorrect Needle and Suture Specifications
Medline Industries is recalling 408 surgical kits from Alabama, Georgia, Massachusetts, New Jersey, and Pennsylvania. Some suture packages within the kits contain incorrect needle types and sizes, and incorrect suture diameters and lengths.
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 supplies with no reported hospitalizations or illnesses. The defect in critical surgical components (incorrect needle types, sizes, and suture specifications) constitutes a risk-of-harm product meeting the rubric criterion for High severity.
Plain-English summary
Medline Industries, LP is recalling approximately 408 surgical kits due to defects in included suture packages. The affected products are the Medline Open Heart CDS (REF CDS840132O) and the Medline Dr. Davies CV (REF DYNJ903016G).
Some suture packages within these convenience kits contain incorrect needle types and sizes, along with incorrect suture diameters and lengths. These defects could potentially affect surgical outcomes if the incorrect components are used during procedures.
The affected kits were distributed to medical facilities in Alabama, Georgia, Massachusetts, New Jersey, and Pennsylvania. Specific lot numbers and expiration dates are identified in the FDA's official recall database.
Healthcare facilities with these kits should discontinue use immediately and contact Medline Industries for replacement or disposal. Medical professionals should verify correct needle and suture specifications are available before proceeding with surgical procedures.
The recalled product
- Product
- (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 408
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 (10)
- (1) REF CDS840132O - Lot number 24BBF701
- exp. 10/31/2024
- UDI-DI each 10195327245276
- UDI-DI case 40195327245277
- (2) REF DYNJ903016G - Lot numbers 24DBP801
- exp. 8/31/2025
- and 24CBJ749
- exp. 11/30/2024
- UDI-DI each - 10195327657154
- UDI-DI case - 40195327657155.
Distribution
Part of a larger recall action
This product is one of 3 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 3 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 · incorrect needle type
See all →- HighMedline Surgical Implant Kits Recalled for Incorrect Suture Specifications
FDA (Devices) · 2024-12-04
- HighEthicon STRATAFIX Surgical Sutures Recalled for Incorrect Needle Type and Size
FDA (Devices) · 2022-05-18
Similar recalls
- HighMedline surgical convenience kits recalled due to weak Pure Pouch seals
FDA (Devices) · 2024-07-10
- HighMedline procedural kit syringes recalled for leaks and breakage
FDA (Devices) · 2024-09-04
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- HighMedline Surgical Procedure Kits Recalled for Defective Plastic Syringes
FDA (Devices) · 2025-04-02
- HighMedline procedure kits recalled for syringe quality defects
FDA (Devices) · 2025-04-02