BLAKERecalls & reported problems across all models
Ethicon Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 739
- Deaths reported
- 0
- Injuries reported
- 141
- Recalls
- 0
We found 18 models of BLAKE by Ethicon Inc. in the FDA's device registry (GUDID). Together they are named in 739 adverse event reports in the FDA's MAUDE database, received between Sep 1, 2017 and Sep 28, 2026 — classified as 141 injuries, 598 malfunctions.
The most frequently reported specific device problem is “Break” (190 reports).
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
Most reported BLAKE problems
Device problems
- Break190
- Leak/Splash168
- Material Integrity Problem147
- Infusion or Flow Problem96
- Device Contaminated During Manufacture or Shipping69
- Suction Problem20
- Adverse Event Without Identified Device or Use Problem15
- Appropriate Device Problem Term/Code Not Available8
Patient problems
- No Clinical Signs, Symptoms or Conditions510
- No Consequences Or Impact To Patient81
- Foreign Body In Patient77
- Insufficient Information28
- Not Applicable26
- Hematoma9
- Unspecified Infection8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
BLAKE models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BLAKE 2227CATHETER, IRRIGATION331 reports
- BLAKE 2233CATHETER, IRRIGATION114 reports
- BLAKE 2229CATHETER, IRRIGATION76 reports
- BLAKE 2232CATHETER, IRRIGATION71 reports
- BLAKE 2217CATHETER, IRRIGATION58 reports
- BLAKE 2230CATHETER, IRRIGATION24 reports
- BLAKE 2216CATHETER, IRRIGATION10 reports
- BLAKE 2234CATHETER, IRRIGATION10 reports
- BLAKE 2214CATHETER, IRRIGATION9 reports
- BLAKE BCC2CATHETER, IRRIGATION9 reports
- BLAKE 2228CATHETER, IRRIGATION7 reports
- BLAKE 2231CATHETER, IRRIGATION7 reports
- BLAKE 2211CATHETER, IRRIGATION4 reports
- BLAKE 2215CATHETER, IRRIGATION3 reports
- BLAKE 2212CATHETER, IRRIGATION2 reports
- BLAKE BCC3CATHETER, IRRIGATION2 reports
- BLAKE 2213CATHETER, IRRIGATION1 report
- BLAKE 2226CATHETER, IRRIGATION1 report
Recent BLAKE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917144 ↗MalfunctionSep 24, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885359 ↗MalfunctionSep 24, 2026Device Contaminated During Manufacture or Shipping
It was reported a patient underwent an unknown procedure on an unknown date and a drain was used. It was found that there was a black dirt on the catheter appearance when opened the package and tried to use it. Another product was used to complete the case. No sample will be returned. There were no adverse consequences to the patient. Further details are not provided. Additional information has been requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881925 ↗MalfunctionSep 23, 2026Material Integrity Problem
It was reported a patient underwent an unknown surgery on an unknown date and a drain was used. The blue stripe on the silicone drain was notably thin and faint in color when the package was opened. After surgery, the drain did not appear in the X-ray image. No additional procedures were performed, and the drain was removed on the scheduled date. There was no effect on the patient. Same product was used to complete the case. There were no adverse consequences to the patient. Further details are not provided.Upon receipt and analysis, product was found to be counterfeit.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871262 ↗MalfunctionSep 23, 2026Material Integrity Problem
It was reported a patient underwent an unknown surgery on an unknown date and a drain was used. The blue stripe on the silicone drain was notably thin and faint in color when the package was opened. After surgery, the drain did not appear in the X-ray image. No additional procedures were performed, and the drain was removed on the scheduled date. There was no effect on the patient. Same product was used to complete the case. There were no adverse consequences to the patient. Further details are not provided.Upon receipt and analysis of additional sample, product was found to be counterfeit.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871259 ↗MalfunctionSep 23, 2026Material Integrity Problem
It was reported a patient underwent an unknown surgery on an unknown date and a drain was used. The blue stripe on the silicone drain was notably thin and faint in color when the package was opened. After surgery, the drain did not appear in the X-ray image. No additional procedures were performed, and the drain was removed on the scheduled date. There was no effect on the patient. Same product was used to complete the case. There were no adverse consequences to the patient. Further details are not provided.Upon receipt and analysis of additional unused representative sample, product was found to be counterfeit.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871253 ↗MalfunctionSep 15, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780810 ↗MalfunctionSep 15, 2026Material Integrity Problem
It was reported that a patient underwent an unknown procedure on an unknown date and a drain was used. During the procedure, the drain had adhered to the trocar needle. Another product was used to complete the case. There were no adverse consequences to the patient. Upon evaluation of the device returned, the received displayed evidence of adherence of the drain to the trocar.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772634 ↗MalfunctionAug 6, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50155881 ↗InjuryJul 30, 2026Break
It was reported a patient underwent an unknown procedure on an unknown date in 2026 and a drain was used. In the (b)(6) post surgery, The patient was cleaning the outside of the drain, by wiping it down the length and the end snapped off. It snapped off nearer to the wound. Drain was discarded and replaced with other. A sample is available, not original. Additional information has been requested.
Patient problems: Insufficient Information
MAUDE report 50089957 ↗InjuryJul 30, 2026Break
It was reported a patient underwent an unknown procedure on an unknown date in 2026 and a drain was used. In the Breast Clinic post surgery, The patient was cleaning the outside of the drain, by wiping it down the length and the end snapped off. Drain was discarded and replaced with other. A sample is available, not original. Additional information has been requested.
Patient problems: Insufficient Information
MAUDE report 50089956 ↗MalfunctionJun 15, 2026Material Integrity Problem
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE WHEN THE PRODUCT WAS USED. THIS EVENT WAS FOUND BEFORE USE. THERE WAS NO EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION, THE DRAIN HAD CHIP MARK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25505020 ↗MalfunctionJun 15, 2026Material Integrity Problem
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE AND THE DRAIN WAS DAMAGED WHEN SEPARATED THEM. THIS EVENT WAS FOUND BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION, A STICKY MARK OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25504003 ↗MalfunctionJun 8, 2026Material Integrity Problem
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN HAD BEEN ADHERED TO THE BENDABLE TROCAR NEEDLE, AND WHEN THEY WERE SEPARATED, A FOREIGN MATTER REMAINED INSIDE THE DRAIN LUMEN. THE PRODUCT WAS NOT USED FOR THE PATIENT, SO THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS, STICKING MARK WAS FOUND AND CHIP MARKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25435868 ↗MalfunctionJun 8, 2026Material Integrity Problem
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND A DRAIN WAS USED. IT WAS FOUND THAT THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE DURING USE AFTER OPENING THE PACKAGE. A HOLE WAS CREATED WHEN SEPARATED THEM AND USE WAS STOPPED. THIS EVENT WAS FOUND BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND EVALUATION, THE DRAIN HAD CHIP MARK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25434854 ↗
Other Ethicon Inc. products
All Ethicon Inc. devices →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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