CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hard…

Recall #: Z-0529-2021
Affected scope: Total pumps = 4,182 (all models)
Initiated: July 30, 2020

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Cme America, LLC recalled CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medic… - a moderate-severity action.

CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medic… was recalled by Cme America, LLC in December 9, 2020. Reason: Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situation…. Check the official notice for the remedy. Verify recall #Z-0529-2021 with the FDA Devices before acting.

The recall

Cme America, LLC issued this moderate-severity FDA Devices recall-Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situation….

Moderate
severity level: Class II
classification: December 9, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0529-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

Reason for recall

Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0529-2021
Date reported	December 9, 2020
Date initiated	July 30, 2020
Recalling firm	Cme America, LLC
Firm location	Golden, CO
Affected scope	Total pumps = 4,182 (all models)
Distribution	Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, AK, CA, CO, CT, FL, ID, IL, KS, LA, MA, MI, MO, MT, NC, NE, NV, Oh, OK, OR, PA, TN, TX, WA, and WI. The country of Canada.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0529-2021) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 9, 2020. Severity: Moderate. Recall number: Z-0529-2021.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, AK, CA, CO, CT, FL, ID, IL, KS, LA, MA, MI, MO, MT, NC, NE, NV, Oh, OK, OR, PA, TN, TX, WA, and WI. The country of Canada..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Neptune Benson Recalls Delta Ultra-Violet… 2020-12-09 Spirit Halloween Recalls Children's Flash… 2020-12-09 Fiskars Brands Recalls 16 Foot Pole Saw/P… 2020-12-09 Burley Recalls Child Bicycle Seats Due to… 2020-12-09

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Olympus Ultrasound Endoscope, Model numbe… 2020-12-09 Olympus Ultrasound Endoscope, Model Numbe… 2020-12-09 Olympus Ultrasound Endoscope, Model numbe… 2020-12-09 Olympus Ultrasound Endoscope, Model numbe… 2020-12-09

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported December 9, 2020. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026