Data Foundry

Medical device recalls 2022

The following first aid kits and cabinets containing components… — Class II medical device recall Z-1060-2022

Terminated recall by Certified Safety Mfg Inc, reported 2022-05-18, distributed in AL, AZ, CA, CO, CT, FL, GA, IL…. First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufact

Recall numberZ-1060-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCertified Safety Mfg Inc, Kansas City, MO, United States
Recall initiated2022-04-05
Classified2022-05-11
Reported by FDA2022-05-18
Terminated2026-08-04
DistributedAL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, WI, WV, WY
Quantity14,685 kits
Reason classescgmp
UPC / GTIN / UDI-DI00766588160061, 00766588160085, 00766588160153, 00766588160337, 00766588160665, 00766588160672, 00766588160726, 00766588180137, 00766588180168, 00766588206097
Lot numbers07046, 07332, 07741, 07768, 07779, 08281, 08586, 08684, 08834, 6139, 6348, 6428, 6529, 6558, 6583, 6641, 6935, 7572, 7971

Product

The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Firestone Supplemental - w/Logo; (2) KR614-020 16R - Firestone Supplemental - Refill; (3) K616-033 36M - Class A Office - Metal; (4) KR616-006 36R - Class A Office - Refill; (5) KR616-015 75R - Class A Office - Refill; (6) K616-015 75V - Class A Office - 3-Shelf Cabinet; (7) K618-016 EMT - Duke Energy TD - Red Bag; (8) KR618-016 EMTR - Duke Energy TD - Refill; (9) K616-008 FAC-3 - Class B + Meds - 3 Shelf Cabinet; (10) KR616-008 FAC-3R - Class B + Meds - Refill; (11) K618-013 FAC-3 - Five Star Safety - w/Logo; (12) K611-044 FAC-3 - Uline 100 person - w/Logo; (13) K620-609 FAC-3 - Uline Class B + Meds - w/Logo; (14) K616-072 FAC-4 - Choate Construction - w/Logo; (15) KR616-072 FAC-4R - Choate Construction - Refill; (16) K616-066 FAC-4 - Class B + Meds - 4 Shelf Cabinet; (17) KR616-066 FAC-4R - Class B + Meds - Refill; (18) K612-159 FAC-4 - Uline - w/Logo - w/Contents sticker; (19) K616-067 FAC-5 - Class B - 5 Shelf Cabinet; (20 KR616-067 FAC-5R - Class B - Refill

Reason for recall

First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1060-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.