Data Foundry

Medical device recalls 2020

Pressure Monitoring Set — Class II medical device recall Z-2203-2020

Terminated recall by Cook Inc., reported 2020-06-10, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the

Recall numberZ-2203-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCook Inc., Bloomington, IN, United States
Recall initiated2020-04-30
Classified2020-06-02
Reported by FDA2020-06-10
Terminated2021-03-29
DistributedAK, 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, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV
Countries outside the USMX
Quantity6,792
Reason classesdevice malfunction
Lot numbers10109034, 10111785, 10130377, 10130378, 10134000, 10148417, 8910219, 8937938, 8951879, 8979177, 8990088, 9007566, 9008052, 9039794, 9351985, 9351986, 9354853, 9359896, 9367663, 9372621, 9380316, 9381545, 9386056, 9386351, 9389523, 9395471, 9395682, 9395683, 9402026, 9403779, 9406107, 9409058, 9412543, 9414585, 9416780, 9486988, 9785433, 9799632, 9799638, 9826828 and 28 more

Product

Pressure Monitoring Set, C-PMS, G02838

Reason for recall

The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.

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-2203-2020. 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.