Bottle, Collection, Vacuum
FDA adverse event reports and recall history for bottle, collection, vacuum (product code KDQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,137
- Deaths
- 55
- Injuries
- 441
- Malfunctions
- 1,477
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-09-11Open, ClassifiedProcess control
Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
- 2024-08-22Open, ClassifiedUnder Investigation by firm
LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-22Open, ClassifiedUnder Investigation by firm
LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-22Open, ClassifiedUnder Investigation by firm
1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-22Open, ClassifiedUnder Investigation by firm
1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-22Open, ClassifiedUnder Investigation by firm
1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-22Open, ClassifiedUnder Investigation by firm
1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-22Open, ClassifiedUnder Investigation by firm
Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2023-12-02Open, ClassifiedLabeling mix-ups
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
- 2023-03-30Open, ClassifiedUnder Investigation by firm
Atrium Pneumostat Chest Drain Valve, Part Number 16100
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
Monitor bottle, collection, vacuum automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.