CriticalClass IOngoing

FDA Devices recall · Reported May 14, 2025

CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH 1/EA, Model Number: 21-2120-0103-01; 4) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51; 5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on May 14, 2025. Severity: Critical. Recall number: Z-1682-2025.

Q: Where was the recalled product distributed?

Distribution: Worldwide - US Nationwide distribution..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1682-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: 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.

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Recall #: Z-1682-2025
Affected scope: 313,676 items
Initiated: April 10, 2025

Compiled from official public sources by the editorial team. · Updated July 2026

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Smiths Medical Asd, Inc. recalled CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120,… - a critical-severity action.

CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120,… was recalled by Smiths Medical Asd, Inc. in May 14, 2025. Reason: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.. Check the official notice for the remedy. Verify recall #Z-1682-2025 with the FDA Devices before acting.

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The recall

Smiths Medical Asd, Inc. issued this critical-severity FDA Devices recall-There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps..

Critical
severity level: 314K units
affected scope: Class I
classification: May 14, 2025
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1682-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1682-2025) was formally reported on May 14, 2025, with the manufacturer initiating the action on April 10, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Smiths Medical Asd, Inc. is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 313,676 items, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution.. Distribution scope 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, 3 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 recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.

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

Severity

Critical

Affected scope

313,676 items

Related Recalls

3 from same agency

Product description

CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH 1/EA, Model Number: 21-2120-0103-01; 4) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51; 5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-01; 6) PUMP KIT, CADD-SOLIS VIP, MDL 2120, CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-51; 7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE 1/EA, Model Number: 21-2127-0104-01; 8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00; 9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-78; 10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER 1/EA, Model Number: 21-2120-0102-78; 11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-231; 12) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249; 13) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-249; 14) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, FACTORY LIBRARY 1/EA, Model Number: 21-2125-0104-01; 15) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249.

Reason for recall

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Ongoing
Recall number	Z-1682-2025
Date reported	May 14, 2025
Date initiated	April 10, 2025
Recalling firm	Smiths Medical Asd, Inc.
Firm location	Minneapolis, MN
Affected scope	313,676 items
Distribution	Worldwide - US Nationwide distribution.

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

Scale of Impact

313,676 items units affected - multi-state distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) ✓ This recall

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

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

Check the recall number (Z-1682-2025) 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.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on May 14, 2025. Severity: Critical. Recall number: Z-1682-2025.

Where was the recalled product distributed? ▼

Distribution: Worldwide - US Nationwide distribution..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1682-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

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.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 14, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.