Reported Oct 26, 2022 · Ongoing

Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only;…

Teleflex LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: TELEFLEX LLC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437

Is this the product you have?

Iso-Gard Filter S, with Expandi-Flex, Tethered Cap
REFa) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use

Lot codes and dates: a) 19261T
UDI
(01)04026704400492(17)250528(10)20FT51
(01)04026704400492(17)251028(10)KMH20L0409
(01)04026704400492(17)251228(10)KMH21A0086
(01)04026704400492(17)251228(10)KMH21A0190
(01)04026704400492(17)260128(10)KMH21B0163
(01)04026704400492(17)260128(10)KMH21B0343
(01)04026704400492(17)260128(10)KMH21B0355
(01)04026704400492(17)260228(10)KMH21C0177
(01)04026704400492(17)260228(10)KMH21C0387
(01)04026704400492(17)260528(10)KMH21F0156
(01)04026704400492(17)260528(10)KMH21F0337
(01)04026704400492(17)260628(10)KMH21G0426
(01)04026704400492(17)260828(10)KMH21J0020
(01)04026704400492(17)260828(10)KMH21J0245
(01)04026704400492(17)260928(10)KMH21K0142
(01)04026704400492(17)261128(10)KMH21M0182
(01)04026704400492(17)270128(10)KMH22B0151
(01)04026704400492(17)270128(10)KMH22B0248
b) 19262T
UDI
(01)04026704400508(17)250528(10)202025
(01)04026704400508(17)250528(10)202026
(01)04026704400508(17)250628(10)202030
(01)04026704400508(17)250828(10)KMZ20J0163
(01)04026704400508(17)250828(10)KMZ20J0171
(01)04026704400508(17)250828(10)KMZ20J0582
(01)04026704400508(17)250828(10)KMZ20J0586
(01)04026704400508(17)250828(10)KMZ20J0587
(01)04026704400508(17)250928(10)KMZ20K0681
(01)04026704400508(17)251028(10)KMZ20L0968
(01)04026704400508(17)251028(10)KMZ20L0977
(01)04026704400508(17)251028(10)KMZ20L1275
(01)04026704400508(17)251128(10)KMZ20M0544
(01)04026704400508(17)251128(10)KMZ20M0661
(01)04026704400508(17)251228(10)KMZ21A0175
(01)04026704400508(17)251228(10)KMZ21A0186
(01)04026704400508(17)251228(10)KMZ21A0187
(01)04026704400508(17)251228(10)KMZ21A0208
(01)04026704400508(17)260128(10)KMZ21B0483
(01)04026704400508(17)260128(10)KMZ21B0485
(01)04026704400508(17)260128(10)KMZ21B0495
(01)04026704400508(17)260128(10)KMZ21B0811
(01)04026704400508(17)260128(10)KMZ21B0918
(01)04026704400508(17)260128(10)KMZ21B1172
(01)04026704400508(17)260228(10)KMZ21C0884
(01)04026704400508(17)260228(10)KMZ21C0910
(01)04026704400508(17)260228(10)KMZ21C0929
(01)04026704400508(17)260228(10)KMZ21C0931
(01)04026704400508(17)260328(10)KMZ21D0419
(01)04026704400508(17)260528(10)KMZ21F0223
(01)04026704400508(17)260528(10)KMZ21F0260
(01)04026704400508(17)260528(10)KMZ21F0528
(01)04026704400508(17)260628(10)KMZ21G0728
(01)04026704400508(17)260628(10)KMZ21G0735
(01)04026704400508(17)260628(10)KMZ21G0739
(01)04026704400508(17)260728(10)KMZ21H0055
(01)04026704400508(17)260828(10)KMZ21J0006
(01)04026704400508(17)260828(10)KMZ21J0007
(01)04026704400508(17)260828(10)KMZ21J0008
(01)04026704400508(17)260928(10)KMZ21K0510
(01)04026704400508(17)260928(10)KMZ21K0524
(01)04026704400508(17)260928(10)KMZ21K0539
(01)04026704400508(17)260928(10)KMZ21K0572
(01)04026704400508(17)260928(10)KMZ21K0578
(01)04026704400508(17)260928(10)KMZ21K0592
(01)04026704400508(17)260928(10)KMZ21K0952
(01)04026704400508(17)261028(10)KMZ21L0218
(01)04026704400508(17)261128(10)KMZ21M0674
(01)04026704400508(17)270128(10)KMZ22B0125
(01)04026704400508(17)270128(10)KMZ22B0345
(01)04026704400508(17)270128(10)KMZ22B0809
(01)04026704400508(17)270128(10)KMZ22B0828
(01)04026704400508(17)270128(10)KMZ22B0838
(01)04026704400508(17)270128(10)KMZ22B0869
(01)04026704400508(17)270228(10)KMZ22C0659
c) 19272T
UDI
282 of 282 codes
(01)04026704400515(17)250528(10)202025
(01)04026704400515(17)250528(10)202026
(01)04026704400515(17)250628(10)202027
(01)04026704400515(17)250628(10)202028
(01)04026704400515(17)250628(10)202029
(01)04026704400515(17)250628(10)202030
(01)04026704400515(17)250628(10)202031
(01)04026704400515(17)250628(10)KMZ20G0005
(01)04026704400515(17)250628(10)KMZ20G0026
(01)04026704400515(17)250628(10)KMZ20G0105
(01)04026704400515(17)250628(10)KMZ20G0112
(01)04026704400515(17)250728(10)KMZ20H0081
(01)04026704400515(17)250728(10)KMZ20H0096
(01)04026704400515(17)250728(10)KMZ20H0158
(01)04026704400515(17)250728(10)KMZ20H0379
(01)04026704400515(17)250728(10)KMZ20H0530
(01)04026704400515(17)250728(10)KMZ20H0540
(01)04026704400515(17)250728(10)KMZ20H0564
(01)04026704400515(17)250728(10)KMZ20H0812
(01)04026704400515(17)250728(10)KMZ20H0841
(01)04026704400515(17)250728(10)KMZ20H1021
(01)04026704400515(17)250728(10)KMZ20H1024
(01)04026704400515(17)250728(10)KMZ20H1031
(01)04026704400515(17)250828(10)KMZ20J0092
(01)04026704400515(17)250828(10)KMZ20J0102
(01)04026704400515(17)250828(10)KMZ20J0227
(01)04026704400515(17)250828(10)KMZ20J0441
(01)04026704400515(17)250828(10)KMZ20J0535
(01)04026704400515(17)250828(10)KMZ20J0551
(01)04026704400515(17)250828(10)KMZ20J0566
(01)04026704400515(17)250828(10)KMZ20J0640
(01)04026704400515(17)250828(10)KMZ20J0654
(01)04026704400515(17)250828(10)KMZ20J0663
(01)04026704400515(17)250828(10)KMZ20J0893
(01)04026704400515(17)250828(10)KMZ20J0958
(01)04026704400515(17)250928(10)KMZ20K0034
(01)04026704400515(17)250928(10)KMZ20K0196
(01)04026704400515(17)250928(10)KMZ20K0236
(01)04026704400515(17)250928(10)KMZ20K0430
(01)04026704400515(17)250928(10)KMZ20K0659
(01)04026704400515(17)250928(10)KMZ20K0662
(01)04026704400515(17)250928(10)KMZ20K0838
(01)04026704400515(17)250928(10)KMZ20K0946
(01)04026704400515(17)250928(10)KMZ20K1260
(01)04026704400515(17)250928(10)KMZ20K1289
(01)04026704400515(17)250928(10)KMZ20K1294
(01)04026704400515(17)250928(10)KMZ20K1310
(01)04026704400515(17)250928(10)KMZ20K1339
(01)04026704400515(17)250928(10)KMZ20K1340
(01)04026704400515(17)251028(10)KMZ20L0003
(01)04026704400515(17)251028(10)KMZ20L0030
(01)04026704400515(17)251028(10)KMZ20L0031
(01)04026704400515(17)251028(10)KMZ20L0117
(01)04026704400515(17)251028(10)KMZ20L0214
(01)04026704400515(17)251028(10)KMZ20L0351
(01)04026704400515(17)251028(10)KMZ20L0359
(01)04026704400515(17)251028(10)KMZ20L0499
(01)04026704400515(17)251028(10)KMZ20L0537
(01)04026704400515(17)251028(10)KMZ20L0706
(01)04026704400515(17)251028(10)KMZ20L0724
Amount recalled: 355 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Nationwide

Why it was recalled

Stop using this product now

Incidents of device splitting or detaching during use

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

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8 in total.

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