Covidien, LP Recalls

25 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (25)

June 24, 2026
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Class II
June 24, 2026
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Class II
June 24, 2026
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Class II
June 24, 2026
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Class II
June 24, 2026
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Class II
April 15, 2026
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
Class II
September 25, 2025
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Class II
September 25, 2025
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Class II
September 19, 2024
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Class II
April 15, 2024
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIG
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
Class II
March 15, 2024
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialy
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Class II
March 15, 2024
Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Class II
February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class II
February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class II
February 28, 2024
Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class II
February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class II
February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class II
February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class II
February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class II
February 14, 2024
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
Class II
February 14, 2024
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
Class II
January 25, 2024
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.
Class II
December 21, 2023
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
Class II
December 21, 2023
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* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
Class II
November 16, 2023
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
Class II

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