Device recall: CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number…

Class I FDA enforcement event 96624. Recall start date: 10 Apr 2025. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Smiths Medical ASD, Inc. started this device recall on 10 Apr 2025. The firm address in the FDA record is in Minneapolis, MN. FDA put the recall in Class I. FDA event 96624 has 2 product records. The first FDA enforcement report date is 14 May 2025. The record gives the status Ongoing.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide - US Nationwide distribution.

Recalling firm

Smiths Medical ASD, Inc., Minneapolis, MN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 96624: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1681-2025	CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 4) PUMP KIT,…	313,676 total units	Class I	Ongoing	14 May 2025
Z-1682-2025	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…	313,676 items	Class I	Ongoing	14 May 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2025: 945
Share of these events in Class I: 13%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 108

Other events of the firm

Other FDA enforcement events of Smiths Medical ASD, Inc.
Initiated	Product (first record)	Type	Class	Records
10 Apr 2025	CADD Solis HSPCA Pump *Updated 5/27/26* Scope updated to apply specifically to customers using the wireless system.	Device	Class I	1
10 Apr 2025	CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR	Device	Class I	2
14 Feb 2025	CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100	Device	Class II	2
13 Feb 2025	smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24	Device	Class I	12
13 Feb 2025	Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035	Device	Class I	1
28 Oct 2024	smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP	Device	Class II	3
24 Sep 2024	medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2	Device	Class II	24
18 Jul 2024	smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRW	Device	Class II	5
16 Jul 2024	CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD S	Device	Class I	1
26 Jun 2024	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24	Device	Class II	9

Smiths Medical ASD, Inc.: all 108 events

Official channels

FDA enforcement report Z-1681-2025The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 96624. https://recallregister.com/fda/i/96624/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide - US Nationwide distribution.
What quantity of product is in FDA event 96624?: The event has 2 product records. The first record gives this quantity: 313,676 total units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2025 have the same class?: 13% of the 945 device events that started in 2025 are in Class I.