{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "131286", "product_res_number": "Z-0534-2015", "event_date_initiated": "2014-09-08", "event_date_posted": "2014-12-16", "recall_status": "Terminated", "event_date_terminated": "2017-11-29", "res_event_number": "69471", "product_code": "HFX", "product_description": "A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.", "code_info": "1) Instrumed Product Name: Zipser Meatus Clamp 4 1/4\"; Instrumed Product Number: 330-86112; Trade Name: Medline Industries; Medline Industries Product Name: CLAMP, ZIPSER MEATUS, OVERALL LGTH 4-1/4; Medline Industries Item Number: MDG5597111; Lot Numbers: 051208, 060810.   2) Instrumed Product Name: Zipser Meatus Clamp 4 1/4\"; Instrumed Product Number: 330-86112; Trade Name: Boss Instruments; Boss Instruments Product Name: Zipser Meatus Clamp 4 1/4\"; Boss Instruments Item Number: 46-5195; Lot Number: 060810.   3) Instrumed Product Name: Zipser Meatus Clamp 4 1/4\"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4\"; Millennium Surgical Item Number: 9-124570; Lot Number: 060810.   4) Instrumed Product Name: Zipser Meatus Clamp 4 1/4\"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4\"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810.   5) Instrumed Product Name: Zipser Meatus Clamp 4 1/4\"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4\"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810.   6) Instrumed Product Name: Zipser Meatus Clamp 4 1/4\"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4\"; Millennium Surgical Item Number: 9-124570; Lot Numbers: 060810, 080713, 082213.   7) Instrumed Product Name: Zipser Meatus Clamp 4 1/4\"; Instrumed Product Number: 330-86112; Trade Name: Surgical Direct; Surgical Direct Product Name: Zipser Meatus Clamp 4 1/4\"; Surgical Direct Item Number: SD16450.100; Lot Number: 060810.   8) Instrumed Product Name: Zipser Meatus Clamp 4 1/4\"; Instrumed Product Number: 330-86112; Trade Name: Surgipro; Surgipro Product Name: Zipser Meatus Clamp 4 1/4\"; Surgipro Item Number: SPGU-4570; Lot Number: 060810.", "firm_fei_number": "1421101", "recalling_firm": "Instrumed International, Inc.", "address_1": "626 Cooper Ct", "city": "Schaumburg", "state": "IL", "postal_code": "60173-4537", "additional_info_contact": "Ms. Jennifer S. Staunton\n847-908-6119", "reason_for_recall": "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as \"Pre-Amendment\" devices.", "root_cause_description": "No Marketing Application", "action": "Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.", "product_quantity": "81 clamps", "distribution_pattern": "Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.", "openfda": { "k_number": [ "K221356", "K894201", "K131373", "K212911", "K251687", "K032091", "K010867", "K151095", "K063429", "K103695", "K061539", "K926535", "K935697", "K935491", "K884290", "K970282", "K121789", "K043533", "K040052", "K945949", "K900370", "K142163", "K100916", "K890897", "K033403", "K974286", "K926471" ], "registration_number": [ "3005595283", "3008403546", "3013358456", "3006061749", "1720929", "1058584", "1423507", "3008338766", "1417592", "3004519921", "8040263", "3003644849", "1422634", "1030451", "9710524", "3004111573", "3002834291", "3011499367", "3017907745", "1423537", "1824619", "8040233", "1720747", "1836161", "3015895045", "1928237", "3004598675", "3027556548", "1123010", "9616088", "3012936366", "3035642068", "2916714", "1018470", "3010041511", "3004215117", "9611112", "3005012805", "3011137372", "3003322138", "1061124", "3015173212", "1924066", "8010099", "3002090132", "2431166", "1921846", "3005739654", "1722684" ], "fei_number": [ "3005595283", "3008002452", "3008403546", "1000220650", "3002902735", "1000219637", "3005747797", "3013358456", "3006061749", "2523865", "3002750084", "1720929", "3001236905", "3008338766", "1417592", "3003644849", "1030451", "3004111573", "1000123297", "3008782585", "3002834291", "3011499367", "3003499455", "3017907745", "1824619", "1000555370", "1720747", "3015895045", "1000514656", "1928237", "3004598675", "3027556548", "5870", "3012936366", "3035642068", "1000512168", "2916714", "3003944071", "3005846326", "1018470", "3010041511", "3004215117", "3005012805", "3003322138", "3015173212", "1924066", "3002090132", "1921846", "3005739654" ], "device_name": "Clamp, Circumcision", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.4530", "device_class": "2" } } ] }