Thora-SealRecalls & reported problems across all models
Cardinal Health 200, LLC · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Thora-Seal model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of Thora-Seal by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2021 and Jan 8, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Decrease in Suction” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Thora-Seal recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 26, 2025Open, Classified
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
Z-1203-2026 · Root cause: Error in labeling · names 3 of these models · Recall details · FDA record ↗
Most reported Thora-Seal problems
Device problems
- Decrease in Suction1
- Fluid/Blood Leak1
- Gas/Air Leak1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Low Oxygen Saturation1
- Unspecified Blood or Lymphatic problem1
Thora-Seal models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Thora-Seal 8884713100BOTTLE, COLLECTION, VACUUM1 recall0 reports
- Thora-Seal 8884713308BOTTLE, COLLECTION, VACUUM1 recall0 reports
- Thora-Seal 8884713900BOTTLE, COLLECTION, VACUUM1 recall0 reports
- Thora-Seal 8884713308BOTTLE, COLLECTION, VACUUM4 reports
Recent Thora-Seal adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2024Decrease in Suction; Decrease in Suction
THE CUSTOMER REPORTED DUE TO GAS LEAKAGE, CAUSE PATIENT¿S SAFETY SERIOUSLY.ADDITIONAL INFORMATION RECEIVED STATED THE DEVICE WAS LEAKING AIR. THEY WERE UNSURE WHERE THE LEAK WAS COMING FROM. THIS WAS NOTICED AFTER USING AND THE LEAK EFFECTED THE SUCTION. THE AIR COULDN'T BE DRAINED SMOOTHLY CAUSING THE PATIENT'S BLOOD OXYGEN TO DECREASE, BUT THE HEALTHCARE PROVIDER NOTICED AND CORRECTED THE ISSUE.
Patient problems: Unspecified Blood or Lymphatic problem
MAUDE report 18464273 ↗MalfunctionJan 5, 2023Gas/Air Leak; Gas/Air Leak
THE CUSTOMER REPORTED THAT DUE TO THE BUBBLING NOTED IN THE CHEST DRAINAGE UNIT (CDU), THE PHYSICIAN ATTEMPTED TO LOCATE THE SOURCE OF AIR LEAK BUBBLING IN WATER SEAL AND SUCTION CONTROL CHAMBER WITH SUCTION REGULAR ON NOTED WHILE CHEST TUBE WAS CLAMPED. THE CUSTOMER STATED THAT A LEAK FROM PATIENT WAS RULED OUT THEREFORE THE CDU ITSELF MUST BE MALFUNCTIONING. THERE WAS NO INJURY TO THE PATIENT OR STAFF INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16101764 ↗MalfunctionOct 17, 2022Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE HOSPITAL USED CHEST BOTTLE WITH OBVIOUS CREASES IN THE DRAINAGE HOSE OF THE CHEST BOTTLE, CAUSES THE DRAINAGE TO BE UNSMOOTH, CAUSING THE PATIENT¿S BLOOD OXYGEN TO DROP RAPIDLY AND STILL UNDER TREATMENT AT THE HOSPITAL. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Patient problems: Low Oxygen Saturation
MAUDE report 15615102 ↗MalfunctionDec 8, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN THE USER ADDED WATER FROM THE SITE OF SUCTION, THE USER FOUND THAT LEAKAGE HAPPENED FROM THE SITE OF THE WATER SEAL. NO INJURIES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12960180 ↗
Other Cardinal Health 200, LLC products
- JACKSON-PRATT20 models · 13 reports · 19 recalls
- Monoject35 models · 96 reports · 11 recalls
- CONVERTORS38 models · 40 reports · 11 recalls
- Argyle33 models · 58 reports · 7 recalls
- Salem Sump31 models · 40 reports · 7 recalls
- Dover45 models · 241 reports · 2 recalls
- Kendall31 models · 51 reports · 3 recalls
- Kangaroo35 models · 130 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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