Manufacturer

Covidien, LP

57 recalls in our database name Covidien, LP as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 57

HighFDA (Devices)·Z-1183-2023·2023-03-08
Surgical Mesh Recalled Due to Incorrect Collagen Film Placement
Covidien is recalling Parietex Composite Mesh because the collagen film was positioned on the wrong side, which may cause delays in treatment, adhesions, erosion, migration, pain, fistula, hernia recurrence, or implant failure.
Product
Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1173-2023·2023-03-08
Surgical Sutures Recalled Due to Sterile Barrier Breach Risk in Ophthalmic Procedures
Covidien LP is recalling 12,732 units of surgical sutures (nylon and silk, McKesson brand) due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss when used in eye surgery procedures.
Product
Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1175-2023·2023-03-08
Novafil Sutures Recalled for Sterile Barrier Breach Risk
Covidien is recalling 48,492 units of Novafil Monofilament Polybutester Sutures due to a sterile barrier breach in the breather pouch that may increase the risk of infection or vision loss during ophthalmic procedures.
Product
Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33 NOVA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1179-2023·2023-03-08
Surgipro Monofilament Polypropylene Sutures Recalled for Sterile Barrier Breach
Surgipro Monofilament Polypropylene Sutures are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.
Product
Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1180-2023·2023-03-08
Surgipro II Surgical Sutures recalled for sterile barrier breach
Covidien is recalling Surgipro II Monofilament Polypropylene Sutures due to a sterile barrier breach in the breather pouch that may cause infection or vision loss in ophthalmic procedures with direct patient contact.
Product
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X VP-735-X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1181-2023·2023-03-08
Ti-Cron Surgical Sutures Recalled Due to Sterile Barrier Breach
Covidien is recalling Ti-Cron Coated Braided Polyester Sutures due to a sterile barrier breach in the breather pouch. The defect could allow bacterial contamination, posing a risk of infection or vision loss during ophthalmic procedures.
Product
Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TIC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2023·2022-11-23
Endo Stitch V-Loc 180 Sutures Recalled for Needle Breakage During Use
Covidien recalls Endo Stitch V-Loc 180 automated suturing devices due to 210 reports of needles breaking during endoscopic surgery. Broken needle fragments may remain in patients, potentially causing tissue injury and requiring additional imaging.
Product
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0201-2023·2022-11-23
Endo Stitch V-Loc surgical sutures recalled due to needle breakage
Covidien is recalling Endo Stitch V-Loc PBT non-absorbable surgical sutures due to 210 reports of needles breaking during use. Breaking needles may leave fragments in patients, potentially causing tissue injury or requiring additional imaging.
Product
Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1322-2022·2022-07-13
EEA Autosuture Circular Staplers Recalled for Staple Guide Detachment Risk
Covidien is recalling EEA Autosuture Circular Staplers (25mm) because the staple guide may not be securely attached and could disengage during use, potentially allowing the device to cut tissue without forming staples.
Product
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0514-2022·2022-01-26
SonarMed AirWave Monitor Kit recall due to alarm and sensor detection failures
Covidien is recalling 66 SonarMed AirWave Monitor Kits because the alarm may fail to sound and sensors may be incorrectly detected as disconnected, potentially causing the monitor to stop monitoring patients without alerting staff.
Product
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-2359-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Withdrawn for Labeling and Instructions Enhancement
Covidien voluntarily withdrew Palindrome RT Chronic Catheter Kit worldwide to implement improved point-of-use labeling and enhanced instructions for use on each device.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2372-2021·2021-09-08
Palindrome Precision RT Chronic Catheter Kits Withdrawn for Labeling and Instruction Updates
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper use.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2364-2021·2021-09-08
Palindrome RT Repair Kit Voluntary Withdrawal for Labeling and Instructions Enhancement
Covidien voluntarily withdrew Palindrome RT Repair Kit units worldwide to implement point-of-use labeling and enhancements to the Instructions for Use.
Product
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2360-2021·2021-09-08
Palindrome RT Chronic Catheter Kit withdrawn for labeling and instruction improvements
Covidien is voluntarily withdrawing Palindrome RT Chronic Catheter Kit devices worldwide to implement point-of-use labeling and enhanced Instructions for Use.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2365-2021·2021-09-08
Palindrome RT Repair Kit Voluntary Withdrawal for Labeling Enhancement
Covidien is conducting a voluntary withdrawal of Palindrome RT Repair Kit 15 FR TAL 23cm devices to implement improved point-of-use labeling and enhance the Instructions for Use.
Product
Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2362-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement
Covidien is voluntarily withdrawing specific lots of Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and enhancements to device instructions for use.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2358-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement
Covidien is voluntarily withdrawing the Palindrome RT Chronic Catheter Kit to add point-of-use labeling and enhance instructions for use. The withdrawal affects specific lot numbers distributed worldwide.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2373-2021·2021-09-08
Palindrome Precision RT Chronic Catheter Kit Withdrawn for Labeling Enhancements
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to implement point-of-use labeling and enhanced instructions for use. No illnesses or injuries have been reported.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2367-2021·2021-09-08
Palindrome RT Repair Kit voluntary withdrawal for labeling enhancements
Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit to implement improved point-of-use labeling and enhance the Instructions for Use. This affects Item Code 8888541133 (Lot Number 1705400292) distributed worldwide.
Product
Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2370-2021·2021-09-08
Palindrome Precision RT Chronic Catheter Kit recalled for labeling and instruction updates
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to add point-of-use labeling and improve Instructions for Use. No adverse events have been reported.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2368-2021·2021-09-08
Palindrome RT Repair Kit Withdrawn for Labeling and Instructions Enhancements
Covidien, LP is voluntarily withdrawing Palindrome RT Repair Kit 15 FR to implement point-of-use labeling and enhance Instructions for Use.
Product
Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2361-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Labeling Enhancement Withdrawal
Covidien, LP is voluntarily withdrawing Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and Instructions for Use. No injuries or illnesses have been reported.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2366-2021·2021-09-08
Palindrome RT Repair Kit Withdrawn for Enhanced Labeling and Instructions
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 28cm to improve point-of-use labeling and Instructions for Use. No illnesses or injuries have been reported.
Product
Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2369-2021·2021-09-08
Palindrome RT Repair Kit Withdrawn for Labeling and Instruction Enhancements
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit (Lot 1925300162) worldwide to implement improved point-of-use labeling and enhanced Instructions for Use (IFU).
Product
Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2371-2021·2021-09-08
Palindrome Precision RT Catheter Kit Withdrawn for Labeling and Instruction Enhancements
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
Category
Medical Device
Distribution
0 states