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U.S. Department of Health and Human Services

Class 2 Device Recall Hobbs Medical

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  Class 2 Device Recall Hobbs Medical see related information
Date Initiated by Firm March 15, 2006
Date Posted May 03, 2006
Recall Status1 Terminated 3 on June 27, 2006
Recall Number Z-0824-06
Recall Event ID 35011
510(K)Number K833125  
Product Classification unknown device name - Product Code KOG
Product Hobbs Medical 3 Prong Looped Retriever, a disposable device to be used by physician to remove foreign object or cauterize polyp specimens from the GI tract.
REF: 5030 and 5030S
Code Information Lot Numbers: H11-05-040; H11-05-138; H11-05-139; H11-05-140;H11-05-141; H11-05-205.
Recalling Firm/
Hobbs Medical, Inc.
8 Spring St
Stafford Springs CT 06076-1505
For Additional Information Contact Robert J. Coles
Manufacturer Reason
for Recall
Diameter of device at the distal end would prevent it from passing through the endoscope's working channel.
FDA Determined
Cause 2
Process control
Action Hobbs Medical notfied customers by Registered Letter on 3/15/06, requesting return of recalled product.
Quantity in Commerce 254 units
Distribution AK, IA, KY, MI, NH, NC,UT, WI, Canada, and UK

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KOG and Original Applicant = HOBBS MEDICAL, INC.