FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues
The FDA is recalling Palindrome Precision HSI Chronic Catheter Kits 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving medical devices where failure to meet specifications poses a significant risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Palindrome Precision HSI Chronic Catheter Kits with VenaTrac Stylet, manufactured by Covidien LLC. The recall is classified as Class II. The specific issue is that the catheters may not meet antimicrobial specifications.
The recall includes 72,363 units distributed in the United States and 24,631 units distributed internationally. The affected products are identified by item codes with an expiry date of February 2018 and earlier. The products were distributed nationwide in the US and to numerous countries worldwide.
Healthcare providers and consumers should stop using the affected catheter kits and contact the manufacturer or the FDA for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
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
- ModeratePalindrome 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 Precision H Chronic Catheter Recalled for Potential Hub Leakage
FDA (Devices) · 2022-07-13
- SeverePalindrome Precision Chronic Dialysis Catheters Risk Fluid Leakage Due to Hub Defect
FDA (Devices) · 2022-07-13
- HighPalindrome Precision H Chronic Catheter Kit may lack labeled heparin coating
FDA (Devices) · 2024-05-01
- ModeratePalindrome Precision RT Chronic Catheter Kit recalled for labeling and instruction updates
FDA (Devices) · 2021-09-08