Medline suction catheters recalled due to connector separation risk
Medline ClearPro Trach Double Swivel Closed Suction Catheters may have the green connector separate from the device during patient suctioning. The recall affects 34,920 units distributed nationwide and internationally.
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: FDA Class II medical device with a mechanical failure hazard that could impair device function during critical airway suctioning. No reported injuries or illnesses in the source, consistent with the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling 34,920 units of the ClearPro Trach Double Swivel Closed Suction Catheter due to a connector separation hazard. The green connector near the thumb valve can come apart from the main device during patient suctioning, specifically when withdrawing the catheter from an artificial airway.
The recall affects TRACH DOUBLE SWIVEL models in 12 Fr and 14 Fr sizes, with specific lot numbers included in the recall notice. Affected devices were distributed nationwide to all U.S. states and Puerto Rico, as well as internationally to Canada, Chile, Colombia, Panama, Qatar, and the United Arab Emirates.
Healthcare facilities and providers using these devices should verify their inventory against the recalled lot numbers. For information about replacement supplies or additional details, contact Medline Industries or the FDA.
The recalled product
- Product
- MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12T b. TRACH DOUBLE SWIVEL, 14 Fr, Item Number/REF:
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 34,920
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. UDI-DI (GTIN) case: (01)20888277703374
- UDI-DI (GTIN) Each: (01)10888277703377
- Lot Numbers 6921090011
- 6922030011
- b. UDI-DI (GTIN) case: (01)20888277703398
- UDI-DI (GTIN) Each: (01)10888277703391
- Lot Numbers 6921040012
- 6921070011
- 6921080011
- 6921100011
- 6921120011
- 6921120021
- 6922040011
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 · connector separation
See all →- HighBaxter MiniCap Extended Life PD Transfer Set Connector Separation Complaints
FDA (Devices) · 2024-12-04
- HighBaxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall
FDA (Devices) · 2024-12-04
- HighBaxter MiniCap PD Transfer Set Recalled for Female Connector Separation
FDA (Devices) · 2024-12-04
- HighBaxter Peritoneal Dialysis Transfer Set Connector Separation Recall
FDA (Devices) · 2024-12-04
- HighBaxter Dialysis Transfer Set Recalled for Connector Separation
FDA (Devices) · 2024-12-04