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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88622

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 12, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
CardioQuip, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

Z-0035-2022
Recall number
Z-0035-2022
Initiated
May 12, 2021
Classification
Class II
Status
Ongoing
Recalling firm
CardioQuip, LLC
Quantity
1478 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Code information

All Serial numbers

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.

device · product 2 of 4

CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127

Z-0036-2022
Recall number
Z-0036-2022
Initiated
May 12, 2021
Classification
Class II
Status
Ongoing
Recalling firm
CardioQuip, LLC
Quantity
1380 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Code information

All Serial numbers

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.

device · product 3 of 4

CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110

Z-0037-2022
Recall number
Z-0037-2022
Initiated
May 12, 2021
Classification
Class II
Status
Ongoing
Recalling firm
CardioQuip, LLC
Quantity
1646 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Code information

All Serial numbers

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.

device · product 4 of 4

CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134

Z-0038-2022
Recall number
Z-0038-2022
Initiated
May 12, 2021
Classification
Class II
Status
Ongoing
Recalling firm
CardioQuip, LLC
Quantity
369 uniyd

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Code information

All Serial numbers

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.