Reprocessed electrophysiology catheters recalled over small residual particulates in specific lots
Medline ReNewal reprocessed St. Jude Medical diagnostic electrophysiology catheters are recalled because specific lots may contain small residual particulates. The FDA classified the action as Class I.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this reprocessed catheter action as Class I.
Plain-English summary
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheters are being recalled across model numbers including 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH and 401271RH. Affected lots are listed per model in the recall notice, including lot EP250106 for model 401211RH. The recall covers 398 units distributed nationwide in the United States.
The recall was issued because specific lots of reprocessed electrophysiology catheters may contain small residual particulates. The FDA classified the action as Class I, the agency's most serious category.
Hospitals and electrophysiology labs holding these model and lot numbers should quarantine affected stock and follow the manufacturer's instructions for return.
The recalled product
- Product
- Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 398
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)
- 1) 401211RH
- UDI-DI: 10197344043736(each)
- 10197344043736(case)
- Lot Number: EP250106
- 2) 401222RH
- UDI-DI: 10197344043712(each)
- 10197344043712(case)
- Lot Number: EP241118
- 3) 401222RH
- 4) 401223RH
- UDI-DI: 10197344043705(each)
- 10197344043705(case)
- 5) 401226RH
- UDI-DI: 10197344043699(each)
- 10197344043699(case)
- 6) 401226RH
- 7) 401227RH
- UDI-DI: 10197344043682(each)
- 10197344043682(case)
- 8) 401260RH
Distribution
Distributed nationwide across the United States.
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
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighAlcohol prep pads recalled for isopropyl alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
Similar recalls
- CriticalReprocessed electrophysiology catheters recalled over residual material particles
FDA (Devices) · 2026-02-18
- CriticalReprocessed Livewire catheters recalled over residual material particles
FDA (Devices) · 2026-02-18
- SevereReprocessed Electrophysiology Catheters Recalled for Residual Particles
FDA (Devices) · 2026-07-08
- CriticalReprocessed steerable electrophysiology catheters recalled over residual particulates on surfaces
FDA (Devices) · 2025-10-08
- CriticalReprocessed ultrasound catheters recalled over residual material particles inside
FDA (Devices) · 2026-02-18
- CriticalReprocessed electrophysiology catheters recalled over residual particulates on patient surfaces
FDA (Devices) · 2025-10-08