BD SurePath™ Collection Vial 491452Recalls & reported problems
Becton, Dickinson And Company · BD SurePath™ Collection Vial · Class 3
Quick summary
This BD SurePath collection vial holds cervical cell samples for lab testing. Most of the 82 reports describe the vial leaking, and several describe cracked lids found when samples arrived at the lab, requiring recollection. The reports include 1 injury and no deaths, and reports fell from 27 in the previous 12 months to none in the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 82
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10382904914520), received between Mar 1, 2022 and Dec 13, 2024 — classified as 1 injury, 81 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (68 reports).
11 other recalls cover devices cleared under the same FDA submission (P970018); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash68
- Break14
- Crack5
- Device Markings/Labelling Problem2
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions82
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Leak/Splash; Leak/Splash
REPORT 24 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20923869 ↗MalfunctionDec 13, 2024Leak/Splash; Leak/Splash
REPORT 9 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20921916 ↗MalfunctionDec 13, 2024Leak/Splash; Leak/Splash
REPORT 4 OF 26. IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20921809 ↗MalfunctionDec 13, 2024Leak/Splash; Leak/Splash
REPORT 11 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20921611 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 5 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20921208 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 21 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20921198 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 20 OF 26. IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20921132 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 16 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20920835 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 8 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20920654 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 19 OF 26. IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20920653 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 12 OF 26. IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20920259 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 14 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20920197 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 6 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20920157 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 15 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20919592 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 18 OF 26. IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20919136 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 7 OF 26. IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20919063 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 17 OF 26. IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20918098 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 26 OF 26. IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20917578 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 10 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20917296 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 22 OF 26. IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20916413 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 23 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20916172 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 13 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20915894 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 25 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20915277 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 3 OF 26. IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20915190 ↗MalfunctionDec 12, 2024Leak/Splash; Leak/Splash
REPORT 2 OF 26 IT WAS REPORTED WHEN THE BD SUREPATH¿ COLLECTION VIAL ARRIVED AT THE LAB FOR TESTING, THE VIAL LID WAS CRACKED. THE SAMPLE WILL NEED TO BE RECOLLECTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20914346 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P970018. One submission often covers many models, so check the product and lot details in each record.
- Z-0877-2017 · Feb 12, 2016 · TerminatedBD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath Preservative Fluid is designed for use with the PrepStain System
- Z-1815-2012 · Mar 22, 2012 · TerminatedPrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recal
- Z-1812-2012 · Mar 22, 2012 · TerminatedPrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
- Z-1811-2012 · Mar 22, 2012 · TerminatedPrepStain Syringing Pipettes 240 (Catalog #490517)
- Z-1814-2012 · Mar 22, 2012 · TerminatedManual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
- Z-1813-2012 · Mar 22, 2012 · TerminatedPrepStain Installation Kit (PreCoat), Catalog/Model # 490528
- Z-2086-2012 · Dec 8, 2011 · TerminatedPrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are in
- Z-2087-2012 · Dec 8, 2011 · TerminatedPrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in t
- Z-2088-2012 · Dec 8, 2011 · TerminatedPrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424)
- Z-2085-2012 · Dec 8, 2011 · TerminatedPrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use i
- Z-1090-2009 · Sep 26, 2008 · TerminatedBD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05
Other Processor, cervical cytology slide, automated devices
- BD Totalys SlidePrep 491346Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated53 reports
- BD PrepStain Slide Processor 490100Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated24 reports
- BD Totalys MultiProcessor 443327Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated13 reports
- BD Totalys™ MultiProcessor Consumables Kit 491453Becton, Dickinson And Company · Processor, cervical cytology slide, automated4 reports
- BD PrepStain Slide Processor 490407Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated4 reports
- BD PrepStain Slide Processor 490410Tripath Imaging, Inc. · Processor, Cervical Cytology Slide, Automated2 reports
- BD PrepStain™ Consumables Kit 491454Becton, Dickinson And Company · Processor, cervical cytology slide, automated1 report
- BD SurePath™ Preservative Fluid 491337Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.