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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary, precautionary FDA Class II withdrawal for labeling and instruction enhancements with no reported illnesses or injuries, consistent with Moderate severity per the rubric.
Plain-English summary
Covidien, LP has announced a voluntary withdrawal of Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile (Item Code 8888541119). The withdrawal is being conducted to implement point-of-use labeling on each device and to make enhancements to the Instructions for Use (IFU).
Affected units have lot numbers 1708800198, 1714400174, 1904900098, and 2009300086. The product was distributed worldwide.
This is a voluntary measure to improve product labeling and instructions.
The recalled product
- Product
- Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
- Manufacturer
- Covidien, LP
- Category
- Medical Device — Repair Kit
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 1708800198 1714400174 1904900098 2009300086
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
Same manufacturer · Covidien, LP
See all →- SevereSurgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
Same hazard · labeling
See all →- LowNewborn monitor caps recalled over an incorrect sizing guide on labeling
FDA (Devices) · 2026-02-18
- LowSmall newborn monitor caps recalled over an incorrect sizing guide
FDA (Devices) · 2026-02-18
- LowLarge newborn monitor caps recalled over an incorrect sizing guide
FDA (Devices) · 2026-02-18
- LowExtra large newborn monitor caps recalled over an incorrect sizing guide
FDA (Devices) · 2026-02-18
- ModerateSaccharin sweetener packets recalled over undeclared aspartame in the product
FDA (Food) · 2026-02-18
Similar recalls
- HighPalindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
FDA (Devices) · 2015-07-08
- SeverePalindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure
FDA (Devices) · 2015-07-08
- HighPalindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Failure
FDA (Devices) · 2015-07-08
- ModerateCovidien Recalls Palindrome Precision SI Chronic Catheter Kits
FDA (Devices) · 2015-07-08
- HighCovidien Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Defects
FDA (Devices) · 2015-07-08
- HighPalindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
FDA (Devices) · 2015-07-08