{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191727", "product_res_number": "Z-0711-2022", "event_date_initiated": "2021-12-28", "event_date_posted": "2022-03-02", "recall_status": "Open, Classified", "res_event_number": "89488", "product_code": "FDX", "k_numbers": [ "K893729" ], "product_description": "Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.", "code_info": "Affected lots were distributed in the United States from 1/18/2017 to 8/26/2021. These lots have expiration dates of 1/01/2022 through 12/01/2026.\n\nCatalog Number 4310, Package DI M84943100, Package DI Number M84943101;\nCatalog Number 4320, Package DI M84943200, Package DI Number M84943201;\n\nLot Numbers: H12-16-112\nH12-16-113\nH12-16-114\nH01-17-002\nH01-17-003\nH01-17-004\nH01-17-005\nH01-17-101\nH01-17-134\nH01-17-135\nH01-17-136\nH02-17-044\nH02-17-045\nH02-17-046\nH02-17-047\nH02-17-048\nH03-17-113\nH03-17-114\nH03-17-115\nH03-17-116\nH03-17-117\nH03-17-233\nH03-17-234\nH03-17-235\nH03-17-236\nH03-17-237\nH03-17-238\nH05-17-119\nH05-17-120\nH05-17-121\nH05-17-122\nH05-17-123\nH05-17-124\nH06-17-142\nH06-17-143\nH06-17-144\nH06-17-145\nH07-17-112\nH07-17-113\nH07-17-114\nH07-17-115\nH08-17-127\nH08-17-128\nH08-17-129\nH08-17-130\nH08-17-131\nH08-17-269\nH08-17-270\nH08-17-271\nH08-17-272\nH08-17-273\nH09-17-102\nH09-17-103\nH09-17-104\nH10-17-053\nH10-17-056\nH10-17-057\nH10-17-058\nH10-17-059\nH10-17-060\nH10-17-061\nH11-17-146\nH11-17-147\nH11-17-148\nH11-17-149\nH11-17-150\nH11-17-151\nH12-17-120\nH12-17-121\nH12-17-122\nH12-17-123\nH12-17-124\nH02-18-001\nH02-18-002\nH02-18-003\nH02-18-004\nH02-18-005\nH02-18-209\nH02-18-210\nH02-18-211\nH02-18-212\nH02-18-219\nH02-18-220\nH02-18-221\nH03-18-176\nH03-18-177\nH03-18-178\nH03-18-179\nH03-18-180\nH04-18-038\nH04-18-039\nH04-18-040\nH04-18-151\nH04-18-152\nH04-18-153\nH04-18-154\nH04-18-155\nH04-18-156\nH04-18-157\nH05-18-177\nH05-18-178\nH05-18-179\nH05-18-180\nH06-18-111\nH06-18-112\nH06-18-113\nH06-18-114\nH07-18-017\nH07-18-018\nH07-18-019\nH07-18-021\nH07-18-020\nH08-18-070\nH08-18-071\nH08-18-073\nH08-18-072\nH08-18-206\nH08-18-207\nH08-18-208\nH10-18-117\nH10-18-118\nH10-18-120\nH10-18-121\nH10-18-119\nH11-18-133\nH11-18-134\nH11-18-135\nH11-18-136\nH11-18-137\nH01-19-023\nH01-19-024\nH01-19-025\nH01-19-026\nH01-19-027\nH12-18-086\nH12-18-087\nH12-18-088\nH12-18-089\nH12-18-090\nH01-19-178\nH01-19-179\nH01-19-180\nH01-19-181\nH01-19-182\nH01-19-183\nH02-19-184\nH02-19-185\nH02-19-186\nH02-19-187\nH02-19-188\nH02-19-189\nH02-19-190\nH04-19-067\nH04-19-068\nH04-19-069\nH04-19-070\nH04-19-071\nH04-19-072\nH04-19-073\nH05-19-102\nH05-19-103\nH05-19-104\nH05-19-160\nH05-19-161\nH05-19-162\nH05-19-163\nH05-19-164\nH06-19-001\nH06-19-003\nH06-19-004\nH06-19-002\nH06-19-310\nH06-19-311\nH06-19-312\nH06-19-313\nH06-19-314\nH06-19-315\nH06-19-316\nH06-19-317\nH07-19-129\nH07-19-130\nH07-19-131\nH07-19-132\nH07-19-133\nH07-19-134\nH08-19-176\nH08-19-177\nH08-19-178\nH08-19-179\nH08-19-180\nH09-19-113\nH09-19-114\nH09-19-115\nH09-19-116\nH10-19-104\nH10-19-105\nH10-19-107\nH10-19-106\nH10-19-108\nH11-19-120\nH11-19-121\nH11-19-122\nH01-20-008\nH01-20-009\nH01-20-010\nH01-20-011\nH01-20-012\nH01-20-013\nH01-20-207\nH01-20-208\nH01-20-209\nH01-20-210\nH01-20-211\nH01-20-212\nH01-20-213\nH02-20-125\nH02-20-126\nH02-20-127\nH02-20-128\nH02-20-129\nH03-20-169\nH03-20-170\nH03-20-171\nH03-20-173\nH03-20-172\nH04-20-097\nH04-20-098\nH04-20-099\nH04-20-100\nH04-20-101\nH04-20-120\nH04-20-121\nH04-20-122\nH04-20-123\nH04-20-124\nH05-20-109\nH05-20-110\nH05-20-111\nH05-20-112\nH05-20-113\nH05-20-114\nH05-20-115\nH05-20-116\nH05-20-117\nH05-20-118\nH06-20-033\nH06-20-034\nH06-20-035\nH06-20-036\nH06-20-037\nH07-20-060\nH07-20-061\nH07-20-062\nH07-20-063\nH08-20-102\nH08-20-103\nH08-20-104\nH08-20-105\nH08-20-106\nH08-20-107\nH09-20-040\nH09-20-041\nH09-20-042\nH09-20-043\nH10-20-074\nH10-20-075\nH10-20-076\nH10-20-077\nH10-20-078\nH11-20-096\nH11-20-097\nH11-20-098\nH11-20-099\nH11-20-100\nH12-20-160\nH12-20-161\nH12-20-162\nH12-20-163\nH12-20-164\nH01-21-105\nH01-21-106\nH01-21-107\nH01-21-108\nH01-21-110\nH01-21-109\nH02-21-047\nH02-21-048\nH02-21-049\nH02-21-050\nH02-21-051\nH03-21-158\nH03-21-159\nH03-21-160\nH03-21-161\nH03-21-162\nH05-21-137\nH05-21-138\nH05-21-139\nH05-21-140\nH06-21-148\nH06-21-149\nH06-21-150\nH06-21-151\nH06-21-152\nH07-21-005\nH07-21-006\nH07-21-007\nH07-21-008\nH07-21-009\nH07-21-133\nH07-21-134\nH07-21-135\nH07-21-136\nH07-21-137\nH07-21-138\nH12-16-115\nH12-16-116\nH02-17-131\nH02-17-132\nH02-17-133\nH02-17-134\nH02-17-135\nH02-17-136\nH03-17-118\nH03-17-119\nH03-17-120\nH04-17-030\nH04-17-031\nH04-17-032\nH04-17-033\nH05-17-098\nH05-17-099\nH05-17-100\nH05-17-101\nH06-17-146\nH06-17-147\nH06-17-148\nH06-17-149\nH07-17-116\nH07-17-117\nH07-17-118\nH07-17-119\nH08-17-132\nH08-17-133\nH08-17-134\nH08-17-135\nH08-17-274\nH08-17-275\nH08-17-276\nH08-17-277\nH10-17-062\nH11-17-109\nH11-17-110\nH11-17-111\nH11-17-112\nH12-17-125\nH12-17-126\nH12-17-127\nH12-17-128\nH12-17-129\nH02-18-006\nH02-18-007\nH02-18-008\nH02-18-009\nH02-18-010\nH02-18-213\nH02-18-214\nH02-18-215\nH03-18-181\nH03-18-182\nH03-18-183\nH04-18-158\nH04-18-159\nH05-18-181\nH05-18-182\nH05-18-183\nH07-18-022\nH07-18-023\nH08-18-082\nH08-18-083\nH08-18-084\nH08-18-204\nH08-18-205\nH10-18-114\nH10-18-115\nH10-18-116\nH11-18-138\nH11-18-139\nH11-18-140\nH01-19-184\nH01-19-185\nH01-19-186\nH01-19-187\nH01-19-188\nH01-19-189\nH01-19-190\nH01-19-191\nH01-19-192\nH01-19-193\nH01-19-194\nH01-19-195\nH01-19-196\nH01-19-197\nH01-19-198\nH03-19-087\nH03-19-088\nH03-19-089\nH04-19-124\nH04-19-125\nH04-19-126\nH04-19-127\nH06-19-318\nH06-19-319\nH06-19-320\nH07-19-135\nH07-19-136\nH07-19-1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"firm_fei_number": "1220592", "recalling_firm": "Hobbs Medical, Inc.", "address_1": "8 Spring St", "city": "Stafford Springs", "state": "CT", "postal_code": "06076-1505", "reason_for_recall": "The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.", "root_cause_description": "No Marketing Application", "action": "URGENT MEDICAL DEVICE RECALL notification letters were sent to customers beginning 12/28/21.\n\nActions requested on your part:\n1. Read the Description of the problem section.\n2. Immediately identify and set aside all product listed herein in a manner that ensures the\naffected product will not be used and will be returned to Hobbs Medical.\n3. Review, complete, and return the enclosed Acknowledgement Form directly to Hobbs\nMedical Customer Service, return via Fax at 860-684-7574, or email to\nCustomerService@HobbsMedical.com.\n4. Pass on this notice to anyone in your facility that needs to be informed according to\nyour internal notification procedures.\n5. If any product listed below has been forwarded to another facility, contact that facility\nto arrange return.\n6. Maintain awareness of this notice until all product listed above has been returned to\nHobbs Medical.\nThe following assistance is available:\n-For questions related to the issue or product replacement, please contact Hobbs\nMedical Customer Service.\n-For questions related to product return please contact Hobbs Medical Customer Service\nReturn instructions are provided on the Acknowledgement Form.\n-For questions related to the Acknowledgement Form and its return, please contact\nHobbs Customer Service at 1-800-344-6227", "product_quantity": "38,357 devices", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K844561", "K853530", "K896318", "K960004", "K172663", "K220063", "K912407", "K791668", "K965037", "K834402", "K911481", "K954121", "K103437", "K894863", "K924104", "K893729", "K021998", "K896425", "K880095", "K922851", "K171573", "K923200", "K770913", "K901436", "K192908", "K191485", "K913248", "K902737", "K182231", "K944614", "K250993", "K914504", "K901435", "K151889", "K171607", "K914466", "K040324", "K800966", "K181317", "K860997", "K942144", "K052279", "K930348", "K833330" ], "registration_number": [ "3018094310", "3005987240", "3030446844", "1721686", "1222168", "2183873", "9681260", "1320894", "1820334", "1828132", "3021023752", "1220477", "1000121056", "1056129", "3014769442", "1220592", "3005099803", "3004837686", "9614641", "1223925", "3013440400", "1047843", "3004962788", "2528981", "1000393132", "2183744", "3008797804", "1061927", "8010047", "1825146", "9611594", "1528319", "3013023255", "3004111573", "3007305485", "3011270181", "3011050570", "3004083736", "3009888344", "3013460719", "2246552", "1643817", "9710641", "3003790304", "1037905" ], "fei_number": [ "3018094310", "3005987240", "3030446844", "1721686", "1222168", "2183873", "1000132436", "1820334", "1828132", "3021023752", "1220477", "1000121056", "1000122656", "3014769442", "1220592", "3005099803", "3004837686", "3003565456", "3013440400", "1047843", "3004962788", "1000305720", "2528981", "1000393132", "2183744", "3002806436", "3000203000", "3008797804", "3001451571", "1825146", "3013023255", "3002807795", "3002806565", "3004111573", "3007305485", "3011270181", "3011050570", "3004083736", "3009888344", "3013460719", "2246552", "1643817", "3003790304", "3003995201", "1037905" ], "device_name": "Endoscopic Cytology Brush", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }