CLASS II ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report

Ventlab, LLC Stat-Check manual resuscitators recalled by SunMed Holdings

SunMed Holdings is recalling Ventlab, LLC Stat-Check manual resuscitators with integrated manometer, multiple, distributed nationwide in the US. The recall was initiated on 11 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10889483109250, (Item # SC7101B, Case UDI: 30889483109254); UDI-DI: 10889483160671, (Item # SC7101B-M0. Case UDI: 30889483160675); UDI-DI: 10889483110041, (Item # SC8121B, Case UDI: 30889483110045); UDI-DI: 10889483098677, (Item # SC9101B , Case UDI: 30889483098671). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Quantity recalledN/A

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-0366-2024
FDA event ID: 93237
Recalling firm: SunMed Holdings, Grand Rapids, MI
Classification: Class II
Status: Ongoing
Recall initiated: 11 Oct 2023
FDA classified: 21 Nov 2023
Reported: 29 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

11 Oct 2023	Recall initiated by company
21 Nov 2023	Classified by FDA	+41 days
29 Nov 2023	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 backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

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

Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Check Infant Resuscitator RES #s: SC7101B & SC7101B-M0; 3. STAT-Check Pediatric Resuscitator REF #: SC8121B.

Where it was distributed

US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.

Nationwide Arkansas Arizona California Colorado Connecticut Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Minnesota North Carolina North Dakota New Hampshire

Questions about this recall

Is Ventlab, LLC Stat-Check manual resuscitators with integrated manometer, multiple recalled?

Yes. SunMed Holdings recalled Ventlab, LLC Stat-Check manual resuscitators with integrated manometer, multiple on 11 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0366-2024.

Why was it recalled?

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Which lots are affected?

UDI-DI: 10889483109250, (Item # SC7101B, Case UDI: 30889483109254); UDI-DI: 10889483160671, (Item # SC7101B-M0. Case UDI: 30889483160675); UDI-DI: 10889483110041, (Item # SC8121B, Case UDI: 30889483110045); UDI-DI: 10889483098677, (Item # SC9101B , Case UDI: 30889483098671). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Where was it sold?

US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.

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 SunMed Holdings

All 18

Reported	Class	Recall	Company	Reason	Where
4 Feb 2026Device	CLASS I	Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings	SunMed Holdings	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS I	Broselow" Filled Broselow Organizer recalled by SunMed Holdings	SunMed Holdings	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS I	Broselow Domestic Complete ALS Organizer recalled by SunMed Holdings	SunMed Holdings	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS I	Broselow Pediatric Emergency Rainbow Tape recalled by SunMed Holdings	SunMed Holdings	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS I	Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife) recalled	SunMed Holdings	Lead & Heavy Metals	Nationwide

Other Other Medical Devices recalls

All 13,771

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide