CLASS II ONGOING Device recall · Reported 7 Apr 2021 · FDA Enforcement Report
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS recalled by Covidien
Covidien is recalling CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636, distributed nationwide in the US. The recall was initiated on 26 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1334-2021
- FDA event ID
- 87396
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Feb 2021
- FDA classified
- 1 Apr 2021
- Reported
- 7 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Patient Monitors
Timeline
| 26 Feb 2021 | Recall initiated by company | |
| 1 Apr 2021 | Classified by FDA | +34 days |
| 7 Apr 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
Where it was distributed
Worldwide distribution - US Nationwide distribution.
Questions about this recall
Is CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 recalled?
Yes. Covidien recalled CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 on 26 Feb 2021. The recall is Class II and its status is Ongoing. Recall number Z-1334-2021.
Why was it recalled?
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.
Which lots are affected?
46966F 47358F 47359F 47360F 47361F 47362F 47363F 47364F 47365F 47366F 47367F 47368F 47369F 47370F 47371F 47783F 48082F 48083F 48084F 48085F 48086F 48087F 48088F 48090F 48091F 48092F 48437F 48438F 48439F 48440F 48441F 48442F 48443F 48444F 48445F 48446F 48447F 48448F 48449F 48781F 48782F 48783F 49068F 49069F 49070F 49071F 49072F 49073F 49074F 49075F 49076F 49077F 49078F 49079F 49080F 49081F 49082F 49083F 49084F 49366F 49367F 49368F 49369F 49370F 49371F 49372F 49373F 49374F 49375F 49376F 49377F 49378F 49379F 49380F 49381F 49382F 49383F 49384F 49385F 49386F 49387F 49388F 49663F 49664F 49665F 49666F 49667F 49668F 49911F 49912F 49913F 49914F 50197F 50198F 50199F 50285F 50286F 50287F 50297F 50298F 50299F 50300F 50301F 50370F 50371F 50372F 50374F 50375F 50376F 50377F 50378F 50379F 50380F 50489F 50490F 50595F 50596F 50597F 50598F 50599F 50600F 50601F 50602F 50603F 50604F 50605F 50606F 50607F 50608F 50609F 50610F 50848F 50849F 50850F 50851F 50852F 50853F 50854F 51184F 51185F 51186F 51187F 51188F 51190F
Where was it sold?
Worldwide distribution - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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