Data Foundry

Medical device recalls 2018

Medfusion Syringe Infusion Pump — Class II medical device recall Z-2662-2018

Terminated recall by Smiths Medical ASD Inc., reported 2018-08-15, distributed in AL, AZ, CA, DC, FL, IL, IN, KS…. Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in t

Recall numberZ-2662-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSmiths Medical ASD Inc., Minneapolis, MN, United States
Recall initiated2018-04-13
Classified2018-08-08
Reported by FDA2018-08-15
Terminated2023-01-30
DistributedAL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA
Countries outside the USCA, LB
Quantity276 units
Lot numbersP0239588, P0321444, P0462421

Product

Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism

Reason for recall

Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.

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-2662-2018. 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.