FDA Device recall Z-2300-2012

Various SRI Surgical Disposable Accessory Packs

FDA Device
Class II
terminated
Published 2012-09-05

On 2012-09-05 the FDA classified a Class II recall of Various SRI Surgical Disposable Accessory Packs by Sri Surgical, citing distribution of a product that did not meet specifications. (labeling error).

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2300-2012
Classification	Class II
Status	terminated
Initiated	2008-07-16
Published	2012-09-05
Last updated	2026-09-13 11:53 UTC
Company	Sri Surgical
Distribution	US

Product

Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.

Reason

Distribution of a product that did not meet specifications. (labeling error)

Identifiers

code_info	Model Numbers: CY1020 GY1250 GY1274 GY1274A GY1274B GY1274C GS1296 NU1290 OR1288 OR1288A OR1289 GS0880C GS… Model Numbers: CY1020 GY1250 GY1274 GY1274A GY1274B GY1274C GS1296 NU1290 OR1288 OR1288A OR1289 GS0880C GS0880D GS0880E GS0880F LD0994D LD1000A GS0983C LD1019A LD1019B LD1029A OR0986B OR0986C OR0986D GS0935B-M GY1223 GY1223A CY1028C CY1028D ET1023A ET1023B ET1023C ET1023D EY1024A EY1024B EY1024C EY1024D EY1024E GS0764D GS0764E GS0780D GS0780E GS1219 LD1022B LD1022C LD1022D LD1132 LD1132A LD1132B OR1025A GS1043 GS1044 GS0937D GS0937E GS0938B GS0938C GS0995 GS0995A GS0995B GS0995C GY0996 HT0980A HT0980B HT0980C HT0987B HT0987C HT1128 NU0939C NU0939D GS1136 GS1136A GS1136B CL1035 CL1035A CL1035B NU0700G ET1243 ET1243A EY1242 GS1200A GS1245 GS1245B GS1248 GS1248A GS1285 GS1285A GS1285B HT1247 HT1247A HT1247B NU1249 NU1249A NU1249B NU1249C OR1196B OR1244 OR1244A OR1244B OR1244C OR1246 OR1246A OR1246B CL0705F CL0705G CL0705H EY0696E HT0482E HT0482F HT0482G HT1228 HT1234A-M HT1234B-

code_info

Model Numbers: CY1020 GY1250 GY1274 GY1274A GY1274B GY1274C GS1296 NU1290 OR1288 OR1288A OR1289 GS0880C GS…

Model Numbers: CY1020 GY1250 GY1274 GY1274A GY1274B GY1274C GS1296 NU1290 OR1288 OR1288A OR1289 GS0880C GS0880D GS0880E GS0880F LD0994D LD1000A GS0983C LD1019A LD1019B LD1029A OR0986B OR0986C OR0986D GS0935B-M GY1223 GY1223A CY1028C CY1028D ET1023A ET1023B ET1023C ET1023D EY1024A EY1024B EY1024C EY1024D EY1024E GS0764D GS0764E GS0780D GS0780E GS1219 LD1022B LD1022C LD1022D LD1132 LD1132A LD1132B OR1025A GS1043 GS1044 GS0937D GS0937E GS0938B GS0938C GS0995 GS0995A GS0995B GS0995C GY0996 HT0980A HT0980B HT0980C HT0987B HT0987C HT1128 NU0939C NU0939D GS1136 GS1136A GS1136B CL1035 CL1035A CL1035B NU0700G ET1243 ET1243A EY1242 GS1200A GS1245 GS1245B GS1248 GS1248A GS1285 GS1285A GS1285B HT1247 HT1247A HT1247B NU1249 NU1249A NU1249B NU1249C OR1196B OR1244 OR1244A OR1244B OR1244C OR1246 OR1246A OR1246B CL0705F CL0705G CL0705H EY0696E HT0482E HT0482F HT0482G HT1228 HT1234A-M HT1234B-

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2300-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.