Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST

Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information: a. BREAST BIOPSY PACK-LF, Item Number: DYNJ0160598B, Case UDI/GTIN: 40889942051930, Unit UDI/GTIN: 10889942051939, Lot Number: 22IDB852; b. BREAST BIOPSY PACK, Item Number: DYNJ45087C, Case UDI/GTIN: 40195327044764, Unit UDI/GTIN: 10195327044763, Lot Number: 22JBO180; c. LAPAROTOMY PACK, Item Number: DYNJ55654B, Case UDI/GTIN: 40193489956727, Unit UDI/GTIN: 10193489956726, Lot Number: 22JDA974; d. BREAST PACK, Item Number: DYNJ56546C, Case UDI/GTIN: 40195327231164, Unit UDI/GTIN: 10195327231163, Lot Number: 22JBE655; e. SOFT TISSUE PACK, Item Number: DYNJ68311, Case UDI/GTIN: 40193489821933, Unit UDI/GTIN: 10193489821932, Lot Number: 22JBL797,22GBV060; f. HEMORRHOID PACK, Item Number: DYNJ69404, Case UDI/GTIN: 40193489936620, Unit UDI/GTIN: 10193489936629, Lot Number: 22HBI624; g. RECTAL, Item Number: DYNJ901758G, Case UDI/GTIN: 40193489979696, Unit UDI/GTIN: 10193489979695, Lot Number: 22JBQ935; h. BREAST, Item Number: DYNJ905525C, Case UDI/GTIN: 40195327122943, Unit UDI/GTIN: 10195327122942, Lot Number: 22JMF862,22HMH312; i. BREAST, Item Number: DYNJ906000B, Case UDI/GTIN: 40195327092697, Unit UDI/GTIN: 10195327092696, Lot Number: 22IBR879;

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.