ENFit sump tubes recalled after anti-reflux valve breakage complaints
Cardinal Health is recalling all lots of ENFit Salem Sump PVC tubes after complaints of anti-reflux valve breakage due to excessive force during use.
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: Scored 3 under the risk-of-harm criterion: complaints report valve breakage during use of a gastric tube, and no injuries are reported.
Plain-English summary
Salem Sump PVC Tubes are being recalled, covering the ENFit Salem Sump PVC Tube in 10 Fr 36 in (product code 8888264911E), 12 Fr 48 in (8888264929E), 14 Fr 48 in (8888264945E) and 16 Fr (8888264960E).
The firm has received complaints regarding Anti-Reflux Valve breakage due to excessive force during use, and is providing additional guidance for use. The record notes this is an expansion of an earlier action, RES 95214.
The recall covers all lots, distributed worldwide including nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes the breakage complaints and reports no injuries. Facilities should follow Cardinal Health's updated guidance for use.
The recalled product
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit"…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Gastric tube
Distribution
Part of a larger recall action
This product is one of 6 recalled by Cardinal Health 200, LLC 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 · Cardinal Health 200, LLC
See all →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
Same hazard · component breakage
See all →- HighIvenix infusion pump cassette loading levers may break
FDA (Devices) · 2026-06-10
- HighFord and Lincoln windshield wiper arms may break causing wiper failure
NHTSA · 2026-03-31
- HighSilicone stomach tubes recalled after anti-reflux valve breakage complaints
FDA (Devices) · 2025-10-29
- HighPVC stomach tubes recalled after anti-reflux valve breakage complaints
FDA (Devices) · 2025-10-29
- HighGastric sump anti-reflux valves recalled after breakage complaints from excessive force
FDA (Devices) · 2025-10-29
Similar recalls
- HighCardinal Health Salem Sump Stomach Tubes Recalled for Anti-Reflux Valve Breakage
FDA (Devices) · 2024-10-02
- HighCardinal Health Recalls Salem Sump Stomach Tubes Due to Valve Breakage
FDA (Devices) · 2024-10-02
- HighBard Nasogastric Sump Tube Recalled for Inadequate Drainage
FDA (Devices) · 2024-01-31
- HighBard Nasogastric Sump Tubes recalled for reduced suction and drainage
FDA (Devices) · 2024-01-31
- HighBard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage
FDA (Devices) · 2024-01-31
- HighBard Nasogastric Sump Tube Recalled for Inadequate Suction and Drainage
FDA (Devices) · 2024-01-31