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Covidien, LLC

255 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFU recall (Z-2950-2026)Covidien, LLC2026-08-14
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product recall (Z-2653-2026)Covidien LLC2026-07-02
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522 recall (Z-2261-2026)Covidien LLC2026-05-29
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042 recall (Z-2271-2026)Covidien LLC2026-05-29
Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 recall (Z-2272-2026)Covidien LLC2026-05-29
Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 recall (Z-2273-2026)Covidien LLC2026-05-29
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number recall (Z-1557-2026)Covidien LLC2026-03-11
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only recall (Z-2038-2024)Covidien, LLC2024-06-07
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Co recall (Z-2282-2023)Covidien, LLC2023-08-02
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS recall (Z-2008-2023)Covidien, LLC2023-06-26
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, R recall (Z-0955-2023)Covidien, LLC2023-01-12
Puritan Bennett 560 Ventilator, PB560, CFN 4096600 recall (Z-1775-2022)Covidien Llc2022-09-22
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access f recall (Z-1312-2022)Covidien Llc2022-07-07
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access recall (Z-1313-2022)Covidien Llc2022-07-07
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular acces recall (Z-1314-2022)Covidien Llc2022-07-07
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chr recall (Z-1315-2022)Covidien Llc2022-07-07
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute a recall (Z-1316-2022)Covidien Llc2022-07-07
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodia recall (Z-1317-2022)Covidien Llc2022-07-07
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodi recall (Z-1318-2022)Covidien Llc2022-07-07
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemod recall (Z-1319-2022)Covidien Llc2022-07-07
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and recall (Z-1320-2022)Covidien Llc2022-07-07
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with recall (Z-0557-2022)Covidien Llc2022-02-03
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 recall (Z-0495-2022)Covidien Llc2022-01-13
Puritan Bennett 980 Series Ventilator, 980A1ENNISB recall (Z-0338-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980A3ENNISB recall (Z-0339-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980S1ENDICU recall (Z-0340-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980S3ENDICU recall (Z-0341-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980U1ENASAA recall (Z-0342-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC recall (Z-0343-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980U3ESDIUU recall (Z-0344-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator,980X1ENAIQC recall (Z-0345-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC recall (Z-0346-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980X1ENDIUU recall (Z-0347-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980X1ENNISB recall (Z-0348-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980X1JADIJJ recall (Z-0349-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980X1PLDIPC recall (Z-0350-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC recall (Z-0351-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU recall (Z-0352-2022)Covidien Llc2021-12-09
Puritan Bennett 980 Series Ventilator, 980X3JADIJJ recall (Z-0353-2022)Covidien Llc2021-12-09
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic recall (Z-2768-2020)Covidien Llc2020-08-05
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic recall (Z-2769-2020)Covidien Llc2020-08-05
Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI recall (Z-1446-2020)Covidien Llc2020-02-25
Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Euro recall (Z-1447-2020)Covidien Llc2020-02-25
Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product recall (Z-1274-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: I recall (Z-1275-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: I recall (Z-1276-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: I recall (Z-1277-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Ind recall (Z-1278-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: recall (Z-1279-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: In recall (Z-1280-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Ind recall (Z-1281-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Ind recall (Z-1282-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: recall (Z-1283-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Ind recall (Z-1284-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: recall (Z-1285-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: I recall (Z-1286-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Ind recall (Z-1287-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product U recall (Z-1288-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: I recall (Z-1289-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: recall (Z-1290-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage recall (Z-1291-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Us recall (Z-1292-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: recall (Z-1293-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indic recall (Z-1294-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indic recall (Z-1295-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: recall (Z-1296-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: I recall (Z-1297-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: In recall (Z-1298-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: I recall (Z-1299-2020)Covidien LLC2020-02-19
Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201 recall (Z-1300-2020)Covidien LLC2020-02-19
Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventil recall (Z-0497-2019)COVIDIEN LLC2018-12-18
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic recall (Z-0636-2018)Covidien LLC2018-02-16
Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of recall (Z-1739-2017)Covidien LLC2017-03-27
Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 The recall (Z-1740-2017)Covidien LLC2017-03-27
Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of recall (Z-1741-2017)Covidien LLC2017-03-27
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sod recall (Z-1742-2017)Covidien LLC2017-03-27
Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chlori recall (Z-1743-2017)Covidien LLC2017-03-27
Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Cod recall (Z-1744-2017)Covidien LLC2017-03-27
Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity s recall (Z-1745-2017)Covidien LLC2017-03-27
Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item recall (Z-1847-2016)Covidien LLC2016-05-31
Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item recall (Z-1848-2016)Covidien LLC2016-05-31
Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item recall (Z-1849-2016)Covidien LLC2016-05-31
Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Nu recall (Z-1850-2016)Covidien LLC2016-05-31
Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item recall (Z-1851-2016)Covidien LLC2016-05-31
Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item recall (Z-1852-2016)Covidien LLC2016-05-31
Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Nu recall (Z-1853-2016)Covidien LLC2016-05-31
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) recall (Z-1854-2016)Covidien LLC2016-05-31
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) recall (Z-1855-2016)Covidien LLC2016-05-31
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) recall (Z-1856-2016)Covidien LLC2016-05-31
Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) recall (Z-1857-2016)Covidien LLC2016-05-31
Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319 recall (Z-1858-2016)Covidien LLC2016-05-31
Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321 recall (Z-1859-2016)Covidien LLC2016-05-31
Given Imaging Bravo pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitor recall (Z-1619-2016)Covidien LLC2016-05-06
Given Imaging Bravo pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monito recall (Z-1620-2016)Covidien LLC2016-05-06
Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean th recall (Z-1196-2016)Covidien LLC2016-03-21
Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes are recall (Z-1197-2016)Covidien LLC2016-03-21
Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap towelettes are use recall (Z-1198-2016)Covidien LLC2016-03-21
Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are recall (Z-1199-2016)Covidien LLC2016-03-21
Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap towelettes are us recall (Z-1200-2016)Covidien LLC2016-03-21
Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are us recall (Z-1201-2016)Covidien LLC2016-03-21
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