Device recall: Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral…

Class I FDA enforcement event 90816. Recall start date: 29 Aug 2022. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Incidents of device splitting or detaching during use

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

TELEFLEX LLC started this device recall on 29 Aug 2022. The firm address in the FDA record is in Morrisville, NC. FDA put the recall in Class I. FDA event 90816 has 6 product records. The first FDA enforcement report date is 26 Oct 2022. The record gives the status Ongoing.

FDA enforcement report The 6 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.

US nationwide distribution

Recalling firm

TELEFLEX LLC, Morrisville, NC.

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

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

Products

6 product records in the event.

FDA event 90816: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0072-2023	Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.	60,500 units US	Class I	Ongoing	26 Oct 2022
Z-0073-2023	Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use	7 units	Class I	Ongoing	26 Oct 2022
Z-0074-2023	Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use	164 units	Class I	Ongoing	26 Oct 2022
Z-0075-2023	Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,	355 units	Class I	Ongoing	26 Oct 2022
Z-0076-2023	Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use	42 units	Class I	Ongoing	26 Oct 2022
Z-0077-2023	Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)	12 units	Class I	Ongoing	26 Oct 2022

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 2022: 839
Share of these events in Class I: 8%
Product records in this event: 6Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of TELEFLEX LLC
Initiated	Product (first record)	Type	Class	Records
7 May 2026	Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling Wecksorb Neurosponge Strips (C	Device	Class II	1
25 May 2023	Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor	Device	Class II	3
25 May 2023	Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050	Device	Class I	123
28 Apr 2023	Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that requi	Device	Class II	1
12 Apr 2023	Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tr	Device	Class II	1
8 Dec 2022	Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation	Device	Class II	3
28 Sep 2022	Pilling Wecksorb Cylindrical Sponges	Device	Class II	1
20 Sep 2022	Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116).	Device	Class II	1

TELEFLEX LLC: all 9 events

Official channels

FDA enforcement report Z-0072-2023The 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 90816. https://recallregister.com/fda/i/90816/. 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: US nationwide distribution
What quantity of product is in FDA event 90816?: The event has 6 product records. The first record gives this quantity: 60,500 units US
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2022 have the same class?: 8% of the 839 device events that started in 2022 are in Class I.