Lower riskMedical device recall · FDA · Published May 31, 2024
Smiths Medical Pneupac paraPAC Plus 310 Ventilator Kit Recall: Tidal Volume Knob Risk
Smiths Medical recalls Pneupac paraPAC Plus 310 ventilator kits with PEEP and CPAP. The tidal volume knob may shift accidentally when set at high or low volumes, potentially causing incorrect ventilation settings.
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
Take action
Contact the company
📍Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
“Smiths Medical Pneupac paraPAC Plus 310 Ventilator Kit Recall: Tidal Volume Knob Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/54957-smiths-medical-pneupac-parapac-plus-310-ventilator-kit-recall-tidal. Based on FDA recall #Z-2974-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2974-2024%22&limit=1).
Smiths Medical ASD Inc. recalled Pneupac paraPAC plus 310 ventilator kits with PEEP and CPAP (REF P310NXX) worldwide due to potential inadvertent tidal volume knob movement, the FDA said on May 31, 2024.
How to tell if you have it
Brand: Smiths Medical
Product: Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP
Reference: REF P310NXX
Serial numbers: All serial numbers
The hazard
The FDA stated there is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. GovInfoNow's records show 448 reports in FDA's MAUDE database naming Pneupac paraPAC plus since June 2023, 2 of them marked serious.
Context
GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since 2017-06-05. Recent Smiths Medical recalls include the CADD Solis VIP Infusion Pump (2025-04-10), CADD-Solis HPCA Infusion Pump (2025-04-10), and CADD Solis HSPCA Pump (2025-04-10). Other recent recalls of similar products include Philips Respironics Trilogy EV300 Ventilator Software Issue (2026-03-02), Philips Respironics Trilogy Evo Ventilator Software Issue (2026-03-02), and Philips Respironics Trilogy Evo O2 Ventilator Software Issue (2026-03-02).
How to tell if you have this one
Check for the Pneupac paraPAC Plus 310 ventilator kit with PEEP and CPAP, reference number P310NXX, and all serial numbers on the device.
Brand
Smiths Medical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
Worldwide
Recall number
Product, codes & lots
Quantity
Z-2973-2024
Pneupac paraPAC plus 300 ventilator kit, REF P300NXX; All Serial Numbers.
2198 units
Z-2974-2024
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX; All serial numbers
10,240 units
Based on the official FDA remedy
What to do — step by step
Check Device Settings
Verify the tidal volume knob setting to ensure it matches the intended volume range (high: 1000-1500 mL, low: 70-150 mL).
How this recall unfolded
Recall timeline
FDA published this recall 4 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2974-2024 (May 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2974-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.