CLASS II ONGOING Device recall · Reported 12 Nov 2025 · FDA Enforcement Report
Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recalled
Mozarc Medical US is recalling Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC, distributed nationwide in the US. The recall was initiated on 17 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0421-2026
- FDA event ID
- 97848
- Recalling firm
- Mozarc Medical US, Mansfield, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Oct 2025
- FDA classified
- 4 Nov 2025
- Reported
- 12 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 17 Oct 2025 | Recall initiated by company | |
| 4 Nov 2025 | Classified by FDA | +18 days |
| 12 Nov 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A potential issue with the seal integrity of header bag packaging.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC recalled?
Yes. Mozarc Medical US recalled Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC on 17 Oct 2025. The recall is Class II and its status is Ongoing. Recall number Z-0421-2026.
Why was it recalled?
A potential issue with the seal integrity of header bag packaging.
Which lots are affected?
REF Number: 8888101001HP; UDI-DI: (Individual unit) 10884521127890, (Carton) 20884521127897; Lot number: 2430500021
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mozarc Medical US
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Mahurkar Elite PASS Trays recalled by Mozarc Medical US | Mozarc Medical US | Other | Nationwide |
| Device | CLASS II | Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recalled | Mozarc Medical US | Packaging Defects | Nationwide |
| Device | CLASS II | Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recalled | Mozarc Medical US | Packaging Defects | Nationwide |
| Device | CLASS II | Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recalled | Mozarc Medical US | Packaging Defects | Nationwide |
| Device | CLASS II | Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recalled | Mozarc Medical US | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |