Lower risk Medical device recall · FDA · Published March 16, 2021

Cardinal Health OPTICHAMBER Diamond Spacer with Large Mask Recall: Temperature Issues May

Cardinal Health recalls Diamond Spacer with Large Mask (Item 4742326) due to temperature exposure during shipping, which may cause inaccurate results. Affected units shipped between Feb 23, 2021 and March 10, 2021.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1941-2021Medical device Cardinal Health ›

Lower-risk recall

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

Take action

Contact the company

Recalling firmCardinal Health Inc.7000 Cardinal Pl · Dublin, OH 43017-1091

✎ GovInfoNow plain-language explainer

Cardinal Health is recalling Diamond Spacer with Large Mask units that were shipped between February 23, 2021 and March 10, 2021. These units may have been exposed to temperature extremes during shipping, potentially causing inaccurate results. Read more at govinfonow.com/recall/63052-cardinal-health-optichamber-diamond-spacer-with-large-mask-recall-temperature.

Source Summary by GovInfoNow · govinfonow.com/recall/63052-cardinal-health-optichamber-diamond-spacer-with-large-mask-recall-temperature · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1941-2021

Cite this page

“Cardinal Health OPTICHAMBER Diamond Spacer with Large Mask Recall: Temperature Issues May.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/63052-cardinal-health-optichamber-diamond-spacer-with-large-mask-recall-temperature. Based on FDA recall #Z-1941-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1941-2021%22&limit=1).

Cardinal Health Inc. recalled the OPTICHAMBER DIAMON SPACER WITH LARGE MASK due to potential inaccurate results from temperature exposure, the FDA said on March 16, 2021. The agency issued recall number Z-1941-2021 for the Class II device.

How to tell if you have it

OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
UPC: 8373982700
Lots shipped from 2/23/201 to 3/10/2021

The hazard

The devices were exposed to temperature excursions of 31.9°F intermittently over a 2 hour and 15 minute period, which may cause inaccurate results. The FDA recorded no specific incidents or injuries in this recall.

Context

GovInfoNow's records show Cardinal Health Inc. has 11 other recalls on record since 2018-11-16. Recent brand recalls include Enoxaparin 30mg Syringes (2025-08-05), Xolair 75mg Injection (2025-07-30), and Wegovy injection (2025-04-09) due to labeling or temperature issues. Other recent recalls of similar products include Covidien Mon-a-Therm Temperature Probe Recall (2026-04-23) and Covidien Mon-a-Therm Stethoscope Recall (2026-04-23).

How to tell if you have this one

Check for the item number 4742326 on the product label. The product was shipped between February 23, 2021 and March 10, 2021. Look for the NDC/UPC code 8373982700.

Brand
Cardinal Health
Product
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
Category
Medical device

FDA recall event · 14 products

All 14 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 II
Status
Ongoing
Distribution
US Nationwide distribution in the states of FL, GA, SC.

Recall number	Product, codes & lots	Quantity
Z-1929-2021	FREESTYLE LANCETS 28G 100CT Item Number:2975670; NDC/UPC: 699073130013 All lots numbers shipped from 2/23/201 to 3/10/2021	377 boxes of 100 lancets
Z-1930-2021	FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084; NDC/UPC: 57599000101 All lots numbers shipped from 2/23/201 to 3/10/2021	8,959 kits
Z-1931-2021	FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877; NDC/UPC: 57599080000 All lots numbers shipped from 2/23/201 to 3/10/2021	2,115 kits
Z-1932-2021	AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033; NDC/UPC: 456074613 All lots numbers shipped from 2/23/201 to 3/10/2021	100 units
Z-1933-2021	BD UF PEN 32GX4MM 100 NANO Item Number: 4292272; NDC/UPC: 8290320122 All lots numbers shipped from 2/23/201 to 3/10/2021	1,599 boxes of 100 needles
Z-1934-2021	DEXCOM G6 SENSOR 3 PACK Item Number: 5447552; NDC/UPC: 8627005303 All lots numbers shipped from 2/23/201 to 3/10/2021	2357 kits
Z-1935-2021	VAPORIZER VICKS 1.5GAL Item Number: 2354942; NDC/UPC: 328785101508 All lots numbers shipped from 2/23/201 to 3/10/2021	1 unit
Z-1936-2021	ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174; NDC/UPC: 353885009713 All lots numbers shipped from 2/23/201 to 3/10/2021	5,356 boxes of 100 strips
Z-1937-2021	ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788; NDC/UPC: 353885393102 All lots numbers shipped from 2/23/201 to 3/10/2021	531 boxes of 100 lancets
Z-1938-2021	ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443; NDC/UPC: 353885994255 All lots numbers shipped from 2/23/201 to 3/10/2021	144 boxes of 25 strips
Z-1939-2021	ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610; NDC/UPC: 812608030026 All lots numbers shipped from 2/23/201 to 3/10/2021	2,315 boxes of 100 lancets
Z-1940-2021	ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628; NDC/UPC: 812608030019 All lots numbers shipped from 2/23/201 to 3/10/2021	4,896 boxes of 100 lancets
Z-1941-2021	OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326; NDC/UPC: 8373982700 All lots numbers shipped from 2/23/201 to 3/10/2021	375 units
Z-1942-2021	ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862; NDC/UPC: 365702493100 All lots shipped from 2/23/201 to 3/10/2021	537 boxes of 100 strips

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the item number 4742326 on the product label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

FDA distribution: “US Nationwide distribution in the states of FL, GA, SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Georgia, South Carolina.

Recall timeline

FDA published this recall 3 months after the firm started it.

Mar 16, 2021Firm started the recall
Jun 23, 2021FDA classified it Class II
Jun 30, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63052-cardinal-health-optichamber-diamond-spacer-with-large-mask-recall-temperature">Cardinal Health OPTICHAMBER Diamond Spacer with Large Mask Recall: Temperature Issues May (GovInfoNow)</a>

Where this comes from

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-1941-2021 (March 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1941-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.