FDA recall record · openFDA
Covidien LP
55 FDA recalls on record (2023–2026) — 55 device. 55 still ongoing.
25
Class I (most serious)
30
Class II
0
Class III
55
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessiv 25
The potential for trocar seal disengagement when using mesh products incorrectly with the device. 7
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unst 4
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusa 3
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may d 2
Recalls
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200 Class I 2023-06-28 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 88883 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 888810200 Class I 2023-06-28 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP Class I 2023-06-28 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003H Class I 2023-06-28 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629 Class I 2023-06-28 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 888810300 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 888810300 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP Class I 2023-06-28 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002H Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 88 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004H Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 888810300 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888 Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP Class I 2023-06-28 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888 Class I 2023-06-28 Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071; Class II 2026-04-15 Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06 Class II 2025-09-25 Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT; Class II 2025-09-25 Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT Class II 2024-02-28 Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40- Class II 2024-09-19 Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT Class II 2024-02-14 Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Sil Class II 2024-03-15 Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT Class II 2024-02-14 Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT Class II 2024-02-28 Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL Class II 2024-02-28 Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL Class II 2024-02-28 Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL Class II 2024-02-28 Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of Class II 2024-01-25 Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB Class II 2024-02-28 Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surg Class II 2024-04-15 Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS Class II 2024-02-28 Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaT Class II 2024-03-15 Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 888 Class II 2023-12-21 Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number Class II 2023-03-01 VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS Class II 2023-03-22 Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT Class II 2023-01-25 Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended fo Class II 2023-01-11 Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm Class II 2023-08-22 AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material t Class II 2023-11-16 Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMI Class II 2023-03-01 Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK Class II 2023-12-21 Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2) Class II 2023-03-01 Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K) Class II 2023-03-01 VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS Class II 2023-03-22 VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS Class II 2023-03-22
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.