Recall Register

Food, drugs, devices › Firms

SunMed Holdings, LLC

FDA recalling firm · 6 enforcement events · 18 product records · 2022–2025 · MI

SunMed Holdings, LLC has 6 FDA enforcement events on this register (18 product records) between 2022 and 2025: 6 device; the busiest year was 2025 with 3.

50% of its events are Class I; the most common class is Class I (3). 5 events are listed as ongoing; the recalling firm's address is in MI.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
15 Dec 2025Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: NoDeviceClass I4Ongoing
15 May 2025Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.DeviceClass I1Ongoing
1 May 2025Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116FDeviceClass I1Ongoing
11 Oct 2023Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6, AF5140MB-F, AF1140MB-T, AF1140MB-PW,…DeviceClass II9Ongoing
22 Dec 2022Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405DeviceClass II2Ongoing
8 Sep 2022Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91DeviceClass II1Terminated

By type and class

Device6
Class I3
Class II3

Class I: 50% of this firm's events; 18% of all events on the register.

Events by year

22
23
24
25
26
Enforcement events for SunMed Holdings, LLC by year initiated.

Questions and answers

How many FDA recalls has SunMed Holdings, LLC had?

6 enforcement events (18 product records) on this register, 2022–2025: 6 device.

Are any SunMed Holdings, LLC recalls ongoing?

5 events are listed as ongoing in the current openFDA export.

What class are SunMed Holdings, LLC recalls?

3 Class I, 3 Class II. 50% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.