Recall archive / FDA device enforcement
(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, ste... — FDA record Z-1127-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
- Reason
- Reports received of torn corrugated breathing tubes.
- Classification
- Class II
- Recalling firm
- TELEFLEX MEDICAL INC
- Quantity
- 290,809 eaches
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1127-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Batch and UDI numbers: (1) Product 20011: KMH21F0393 (01)04026704388769(17)260528(10)KMH21F0393; KMH21F0394 (01)04026704388769(17)260528(10)KMH21F0394; KMH21F0395 (01)04026704388769(17)260528(10)KMH21F0395; KMH21F0412 (01)04026704388769(17)260528(10)KMH21F0412; KMH21H0094 (01)04026704388769(17)260728(10)KMH21H0094; KMH21H0095 (01)04026704388769(17)260728(10)KMH21H0095; KMH21H0096 (01)04026704388769(17)260728(10)KMH21H0096; KMH21H0110 (01)04026704388769(17)260728(10)KMH21H0110; KMH21H0112 (01)04026704388769(17)260728(10)KMH21H0112; KMH21J0109 (01)04026704388769(17)260828(10)KMH21J0109; KMH21J0110 (01)04026704388769(17)260828(10)KMH21J0110; KMH21J0118 (01)04026704388769(17)260828(10)KMH21J0118; KMH21J0121 (01)04026704388769(17)260828(10)KMH21J0121; KMH21J0124 (01)04026704388769(17)260828(10)KMH21J0124; KMH21K0302 (01)04026704388769(17)260928(10)KMH21K0302; KMH21K0303 (01)04026704388769(17)260928(10)KMH21K0303; KMH21K0306 (01)04026704388769(17)260928(10)KMH21K0306; KMH21K0307 (01)04026704388769(17)260928(10)KMH21K0307; KMH21K0308 (01)04026704388769(17)260928(10)KMH21K0308; KMH21K0320 (01)04026704388769(17)260928(10)KMH21K0320; KMH21K0341 (01)04026704388769(17)260928(10)KMH21K0341; KMH21K0345 (01)04026704388769(17)260928(10)KMH21K0345; KMH21L0156 (01)04026704388769(17)261028(10)KMH21L0156; KMH21B0479 (01)04026704388769(17)260128(10)KMH21B0479; KMH21B0480 (01)04026704388769(17)260128(10)KMH21B0480; KMH21B0482 (01)04026704388769(17)260128(10)KMH21B0482; KMH21B0483 (01)04026704388769(17)260128(10)KMH21B0483; KMH21C0229 (01)04026704388769(17)260228(10)KMH21C0229; KMH21C0230 (01)04026704388769(17)260228(10)KMH21C0230; KMH21C0231 (01)04026704388769(17)260228(10)KMH21C0231; KMH21C0232 (01)04026704388769(17)260228(10)KMH21C0232; KMH21C0241 (01)04026704388769(17)260228(10)KMH21C0241; KMH21C0242 (01)04026704388769(17)260228(10)KMH21C0242; KMH21C0245 (01)04026704388769(17)260228(10)KMH21C0245; KMH21C0246 (01)04026704388769(17)260228(10)KMH21C0246; KMH21C0252 (01)04026704388769(17)260228(10)KMH21C0252; KMH21C0366 (01)04026704388769(17)260228(10)KMH21C0366; KMH21C0367 (01)04026704388769(17)260228(10)KMH21C0367; KMH21C0368 (01)04026704388769(17)260228(10)KMH21C0368; KMH21C0377 (01)04026704388769(17)260228(10)KMH21C0377; KMH21C0378 (01)04026704388769(17)260228(10)KMH21C0378; KMH21D0204 (01)04026704388769(17)260328(10)KMH21D0204; KMH21D0205 (01)04026704388769(17)260328(10)KMH21D0205; KMH21D0206 (01)04026704388769(17)260328(10)KMH21D0206; KMH21E0002 (01)04026704388769(17)260428(10)KMH21E0002; KMH21E0003 (01)04026704388769(17)260428(10)KMH21E0003; KMH21E0004 (01)04026704388769(17)260428(10)KMH21E0004; KMH21F0196 (01)04026704388769(17)260528(10)KMH21F0196; KMH21F0197 (01)04026704388769(17)260528(10)KMH21F0197; KMH21F0198 (01)04026704388769(17)260528(10)KMH21F0198; KMH21F0199 (01)04026704388769(17)260528(10)KMH21F0199; and KMH21F0210 (01)04026704388769(17)260528(10)KMH21F0210. (2) Product 22511 KMH21F0419 (01)04026704388783(17)260528(10)KMH21F0419; KMH21F0433 (01)04026704388783(17)260528(10)KMH21F0433; KMH21G0362 (01)04026704388783(17)260628(10)KMH21G0362; KMH21G0363 (01)04026704388783(17)260628(10)KMH21G0363; KMH21G0439 (01)04026704388783(17)260628(10)KMH21G0439; KMH21H0061 (01)04026704388783(17)260728(10)KMH21H0061; KMH21H0171 (01)04026704388783(17)260728(10)KMH21H0171; KMH21H0199 (01)04026704388783(17)260728(10)KMH21H0199; KMH21H0222 (01)04026704388783(17)260728(10)KMH21H0222; KMH21H0248 (01)04026704388783(17)260728(10)KMH21H0248; KMH21J0209 (01)04026704388783(17)260828(10)KMH21J0209; KMH21J0220 (01)04026704388783(17)260828(10)KMH21J0220; KMH21K0168 (01)04026704388783(17)260928(10)KMH21K0168; KMH21K0376 (01)04026704388783(17)260928(10)KMH21K0376; KMH21K0385 (01)04026704388783(17)260928(10)KMH21K0385; KMH21B0490 (01)04026704388783(17)260128(10)KMH21B0490; KMH21C0159 (01)04026704388783(17)260228(10)KMH21C0159; KMH21C0160 (01)04026704388783(17)260228(10)KMH21C0160; KMH21D0172 (01)04026704388783(17)260328(10)KMH21D0172; KMH21D0316 (01)04026704388783(17)260328(10)KMH21D0316; KMH21D0360 (01)04026704388783(17)260328(10)KMH21D0360; KMH21E0024 (01)04026704388783(17)260428(10)KMH21E0024; KMH21E0223 (01)04026704388783(17)260428(10)KMH21E0223; KMH21F0148 (01)04026704388783(17)260528(10)KMH21F0148; KMH21F0232 (01)04026704388783(17)260528(10)KMH21F0232; and KMH21F0272 (01)04026704388783(17)260528(10)KMH21F0272. (3) Product 22512: KMZ21F0898 (01)04026704388790(17)260528(10)KMZ21F0898; KMZ21G0757 (01)04026704388790(17)260628(10)KMZ21G0757; KMZ21G0865 (01)04026704388790(17)260628(10)KMZ21G0865; KMZ21H0006 (01)04026704388790(17)260728(10)KMZ21H0006; KMZ21H0106 (01)04026704388790(17)260728(10)KMZ21H0106; KMZ21J0245 (01)04026704388790(17)260828(10)KMZ21J0245; KMZ21J0302 (01)04026704388790(17)260828(10)KMZ21J0302; KMZ21J0504 (01)04026704388790(17)260828(10)KMZ21J0504; KMZ21J0505 (01)04026704388790(17)260828(10)KMZ21J0505; KMZ21J0538 (01)04026704388790(17)260828(10)KMZ21J0538; KMZ21L0084 (01)04026704388790(17)261028(10)KMZ21L0084; KMZ21L0407 (01)04026704388790(17)261028(10)KMZ21L0407; KMZ21L0660 (01)04026704388790(17)261028(10)KMZ21L0660; KMZ21C0007 (01)04026704388790(17)260228(10)KMZ21C0007; KMZ21C0166 (01)04026704388790(17)260228(10)KMZ21C0166; KMZ21C0372 (01)04026704388790(17)260228(10)KMZ21C0372; KMZ21C0422 (01)04026704388790(17)260228(10)KMZ21C0422; KMZ21C0722 (01)04026704388790(17)260228(10)KMZ21C0722; KMZ21C0744 (01)04026704388790(17)260228(10)KMZ21C0744; KMZ21C0924 (01)04026704388790(17)260228(10)KMZ21C0924; KMZ21C1306 (01)04026704388790(17)260228(10)KMZ21C1306; KMZ21D0858 (01)04026704388790(17)260328(10)KMZ21D0858; KMZ21D0926 (01)04026704388790(17)260328(10)KMZ21D0926; KMZ21D1057 (01)04026704388790(17)260328(10)KMZ21D1057; KMZ21D1116 (01)04026704388790(17)260328(10)KMZ21D1116; KMZ21E0135 (01)04026704388790(17)260428(10)KMZ21E0135; KMZ21E0203 (01)04026704388790(17)260428(10)KMZ21E0203; KMZ21E0360 (01)04026704388790(17)260428(10)KMZ21E0360; KMZ21F0387 (01)04026704388790(17)260528(10)KMZ21F0387; KMZ21F0554 (01)04026704388790(17)260528(10)KMZ21F0554; KMZ21F0595 (01)04026704388790(17)260528(10)KMZ21F0595; and KMZ21F0702 (01)04026704388790(17)260528(10)KMZ21F0702. (4) Product 22552 KMZ21G0680 (01)04026704388851(17)260628(10)KMZ21G0680; KMZ21G0689 (01)04026704388851(17)260628(10)KMZ21G0689; KMZ21G0711 (01)04026704388851(17)260628(10)KMZ21G0711; KMZ21G0801 (01)04026704388851(17)260628(10)KMZ21G0801; KMZ21H0181 (01)04026704388851(17)260728(10)KMZ21H0181; KMZ21H0182 (01)04026704388851(17)260728(10)KMZ21H0182; KMZ21J0246 (01)04026704388851(17)260828(10)KMZ21J0246; KMZ21J0401 (01)04026704388851(17)260828(10)KMZ21J0401; KMZ21J0584 (01)04026704388851(17)260828(10)KMZ21J0584; KMZ21K0364 (01)04026704388851(17)260928(10)KMZ21K0364; KMZ21K0365 (01)04026704388851(17)260928(10)KMZ21K0365; KMZ21K0608 (01)04026704388851(17)260928(10)KMZ21K0608; KMZ21B1212 (01)04026704388851(17)260128(10)KMZ21B1212; KMZ21B1213 (01)04026704388851(17)260128(10)KMZ21B1213; KMZ21B1241 (01)04026704388851(17)260128(10)KMZ21B1241; KMZ21C0130 (01)04026704388851(17)260228(10)KMZ21C0130; KMZ21C1266 (01)04026704388851(17)260228(10)KMZ21C1266; KMZ21D0957 (01)04026704388851(17)260328(10)KMZ21D0957; KMZ21F0181 (01)04026704388851(17)260528(10)KMZ21F0181; KMZ21F0182 (01)04026704388851(17)260528(10)KMZ21F0182; and KMZ21F0518 (01)04026704388851(17)260528(10)KMZ21F0518. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Korea, Malaysia, Netherlands, Panama, Poland, Slovakia, Spain, and Switzerland.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 1, 2022
- Recall initiation date
- Apr 11, 2022
- Center classification date
- May 24, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.