CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report
Hobbs Bronchial Cytology Brushes recalled by Hobbs Medical
Hobbs Medical is recalling Hobbs Bronchial Cytology Brushes, distributed nationwide in the US. The recall was initiated on 1 May 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2052-2018
- FDA event ID
- 79903
- Recalling firm
- Hobbs Medical, Stafford Springs, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 May 2018
- FDA classified
- 1 Jun 2018
- Reported
- 13 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 1 May 2018 | Recall initiated by company | |
| 1 Jun 2018 | Classified by FDA | +31 days |
| 13 Jun 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device was marketed for uses outside the 510(k) clearance.
Product as listed by the FDA
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.
Where it was distributed
US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
Nationwide ArizonaCaliforniaGeorgiaIllinoisMarylandNew YorkTennesseeTexasVirginia
Questions about this recall
Is Hobbs Bronchial Cytology Brushes recalled?
Yes. Hobbs Medical recalled Hobbs Bronchial Cytology Brushes on 1 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2052-2018.
Why was it recalled?
Device was marketed for uses outside the 510(k) clearance.
Which lots are affected?
H07-17-157 H12-17-004 H10-17-055 H12-17-062 H11-17-101 H12-17-062 H11-17-119 H12-17-064 H11-17-120 H12-17-064 H11-17-121 H12-17-065 H11-17-122 H12-17-066 H11-17-123 H12-17-067 H11-17-124 H01-18-095 H11-17-125 H01-18-096 H11-17-126 H01-18-097 H11-17-127 H01-18-097 H11-17-128 H01-18-098 H11-17-129 H01-18-098 H11-17-130 H01-18-098 H12-17-002 H01-18-099 H12-17-003 H01-18-100 H12-17-003 H01-18-101 H01-18-102
Where was it sold?
US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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