Medikmark, Incorporated Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case: a) Medikmark inc. Staple Removal Set, reorder no. SR-2005, 3600 Bur Wood Drive, Waukegan, IL 60085; b) Maxxim Medical Staple Removal Kit, reorder no. SD-2005, Distributed by Maxxim Medical, Oldsmar, FL 34677. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case: a) Medikmark inc. Staple Removal Set, reorder no. SR-2005, 3600 Bur Wood Drive, Waukegan, IL 60085; b) Maxxim Medical Staple Removal Kit, reorder no. SD-2005, Distributed by Maxxim Medical, Oldsmar, FL 34677.
Brand
Medikmark, Incorporated
Lot Codes / Batch Numbers
reoder no. SR-2005: lots 308045, 309064, 310137, 406019, reorder no. SD-2005: lots 201107, 203003, 204020, 205035, 205172, 207044, 207101, 208125, 210016, 211007, 301006, 302090, 304070, 305043, 306201, 307075, 308071, 309034, 310124, 312017, 401065, 404004
Products Sold
reoder no. SR-2005: lots 308045, 309064, 310137, 406019; reorder no. SD-2005: lots 201107, 203003, 204020, 205035, 205172, 207044, 207101, 208125, 210016, 211007, 301006, 302090, 304070, 305043, 306201, 307075, 308071, 309034, 310124, 312017, 401065, 404004
Medikmark, Incorporated is recalling Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. due to The tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.
Recommended Action
Per FDA guidance
Recall notifications were sent by fax and follow-up registered mail to the direct account distributors and users on 7/12-15/04. The accounts were informed of the potential non-sterility of the product and were instructed to immediately discontinue sale/use of the products and place all inventory in quarantine pending return to Medikmark. Distributors were instructed to sub-recall the kits from their customers. Any questions were directed to 1-847-596-7723.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026