Smiths Medical Recalls Pediatric Endotracheal Intubation Kit Tube Holders
Smiths Medical ASD, Inc. is recalling H4052 Endo Tube Holders because the fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the H4052 Endo Tube Holder, Pedi 3.0mm, which is part of the Pediatric Endotracheal Intubation Kit. The recall involves 135,518 units, with 110,246 distributed nationwide and the remainder distributed internationally to Canada, Cyprus, Great Britain, Ireland, Italy, Jersey, Kuwait, Malta, Poland, Russia, Saudi Arabia, and South Africa.
The recall is due to a defect in the tube fastener on the ET Tube Holder. The fastener may compress the tracheal tube when used. This compression may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
The source text does not specify a consumer action or report any illnesses or injuries. The recall is classified as Class I by the FDA.
The recalled product
- Product
- H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
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)
- Lot Numbers: 2602399
- 2588625
- 2580799
- 2576366
- 2523679
- 2513119
- 2492246
- 2481855
- 2474647
- 2465829
- 2457754
- 2443379
- 2438616
- 2433451
- 2428215
- 2412146
- 2394061
- 2380352
- 2376566
- 2365454
Distribution
Part of a larger recall action
This product is one of 6 recalled by Smiths Medical ASD, Inc. 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 6 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD, Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- SeverePediatric Tracheostomy Tubes Recalled Due to Defective Securement Flange
FDA (Devices) · 2024-09-04
- HighSmiths Medical Tracheal Intubation Stylet Recall Due to Incorrect Device
FDA (Devices) · 2021-09-08
- HighET Tube Holder Recalled for Risk of Facial Skin Injury
FDA (Devices) · 2024-12-25
- ModerateSmiths Medical Recalls Pediatric Tracheostomy Tubes Due to Packaging Error
FDA (Devices) · 2020-07-08
- HighTracheal Tube Holder Recalled for Defect Causing Potential Skin Pressure Injury
FDA (Devices) · 2024-12-25
- ModerateSmiths Medical Recalls Mislabelled Pediatric Tracheostomy Tubes
FDA (Devices) · 2017-03-22