Hazard

Tubing Separation recalls

10 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 10
Critical: 0
Severe: 2
Most recent: 2025-10-01

Of the 10 tubing separation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (20%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all tubing separation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–10 of 10

HighFDA (Devices)·Z-2594-2025·2025-10-01
Intravenous solution sets recalled after customer reports of tubing separation
Baxter is issuing an urgent recall for one lot of Continu-Flo Solution Sets, REF 2C8519, after customer reports of tubing separation. 14,400 units are affected.
Product
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2296-2025·2025-08-20
Custom waste management kit tubing may trap air in the line
Custom Waste Management Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 858 units affected.
Product
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2025·2025-08-20
Custom manifold kit tubing may separate and trap air in line
Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.
Product
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2294-2025·2025-08-20
Custom tubing kits recalled because high pressure tubing may trap air
Custom Tubing Kits under REF K04-00417, K04-00963 and K04-01029 are recalled because high pressure tubing may separate from its connector and trap air that could reach the patient. 2,779 units are affected.
Product
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2293-2025·2025-08-20
High pressure tubing may separate and trap air in the line
High Pressure Tubing is being recalled because it may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 8,040 units affected.
Product
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1102-2021·2021-02-17
Baxter IV Catheter Extension Set Recalled for Tubing Separation
Baxter Healthcare is recalling 66,800 units of ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Sets due to reports of tubing separation from the Male Luer Lock Adaptor.
Product
Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions w
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1070-2019·2019-04-03
ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation Risk
ICU Medical is recalling specific lots of Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.
Product
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1072-2019·2019-04-03
ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation
ICU Medical is recalling Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.
Product
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1071-2019·2019-04-03
ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation
ICU Medical is recalling 280 Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.
Product
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2285-2013·2013-10-02
CareFusion Recalls SmartSite Infusion Sets Due to Tubing Separation Risk
CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the tubing sleeve may separate below the drip chamber.
Product
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Category
Medical Device
Distribution
Distributed nationwide