Palindrome SI Chronic Catheters Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a failure to meet antimicrobial specifications, which is a potential risk rather than a confirmed injury event, fitting the criteria for a moderate severity score.
Plain-English summary
Covidien LLC is recalling specific units of the Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm (Item Code: 8888128458). The recall is being conducted because the catheters may not meet antimicrobial specifications.
The recall involves 72,363 units in the United States and 24,631 units internationally. The affected products were distributed nationwide in the US and to numerous countries worldwide. The specific units subject to the recall are identified by an expiry date of February 2018 and earlier.
Healthcare providers and consumers should stop using the affected catheters and contact the manufacturer for further instructions or replacement.
The recalled product
- Product
- Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
- 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)
- Item codes identified with an expiry date of February 2018 and earlier
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 62 recalled by Covidien LLC 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 62 products in this recall →Related recalls
Same manufacturer · Covidien LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
Same hazard · infection risk
See all →- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighPalindrome Precision Chronic Catheter Kit Recalled for Packaging Defect
FDA (Devices) · 2015-12-02
- ModeratePalindrome Chronic Catheter Kit Recalled for Packaging Defect
FDA (Devices) · 2015-12-02
- SeverePalindrome SI Chronic Dialysis Catheters Recalled for Hub Leaking Risk
FDA (Devices) · 2022-07-13
- ModeratePalindrome Precision RT Chronic Catheter Kit recalled for labeling and instruction updates
FDA (Devices) · 2021-09-08
- HighPalindrome Precision SI Chronic Hemodialysis Catheter Sterile Barrier Recall
FDA (Devices) · 2025-06-11
- HighPalindrome Chronic Catheter Kit recalls devices with incorrect length labeling
FDA (Devices) · 2023-10-04