Reported Jan 3, 2024 · Ongoing

Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors…

Steris Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834

Is this the product you have?

3 of 3 products

Products covered by this recall
Model / number	Product as published
`ASSY-HOOK-UP,STORZ,5K`	PTX I20 FWJ 2-8-540
`ASSY,HKUP,FUJI-5`	HKUP, OLY 2 BIOPSY 2-8-623
`HOOKUP,PENTAX,70ULT`	HOOKUP FUJI 4K+JET 2-8-536HAN

Lot codes and dates: 25 of 25 products
Products covered by this recall
Model / number Barcodes Product as published
PENTAX-0K 00677964071348 2-8-040 ASSY, HKUP STORZ 0K 00677964072284 2-8-070 ASSY, HU VISION SCIENCE 00677964094637 2-8-112 ASSY, HOOKUP OLMPUS 1K 00677964071300 2-8-120 ASSY, HOOKUP FUJI 1K 00677964102080 2-8-210 ASSY, HOOK-UP OLYMPUS 2K 00677964068485 2-8-213 ASSY, HOOKUP
OLYMPUS-2K 00677964070648 2-8-218 ASSY HOOKUP OLY 2K 00677964072369 2-8-236 ASSY, HOOKUP FUJINON 2K 00677964072376 2-8-244 ASSY, HOOKUP, STORZ 2K 00677964071836 2-8-245 ASSY, HOOK-UP, STORZ 2K 00677964071195 2-8-246 ASSY, HKUP
PENTAX-2K 00677964084058 2-8-260 ASSY, HOOK-UP WOLF
2-K 00677964105951 2-8-280 ASSY HOOKUP 00677964073069 2-8-312 ASSY, HOOK-UP
OLYMPUS-3K 00677964074400 2-8-330 ASSY, HOOK-UP
PENTAX-3K 00677964073816 2-8-332 ASSEMBLY, HOOK-UP, PENTAX 00677964091483 2-8-334 ASSEMBLY, HOOK-UP, PENTAX 00677964073830 2-8-335 ASSY, HOOKUP, OLYMPUS, 3K 00677964071263 2-8-336 ASSY,HKUP FUJI 70 BRONC 00677964091506 2-8-338 ASSY, HU, FUJI BRONCH U/S 00677964074141 2-8-421 ASSY, HOOKUP, FUJIFILM 00677964071270 2-8-428 ASSY
ED-580XX 00677964104923 2-8-431 ASSY, HOOKUP, PENTAX 00677964071706 2-8-432 ASSY, HOOK-UP, PENTAX 00677964072239 2-8-460 HOOKUP, ASSY WOLF 4K 00677964092756 2-8-511 ASSY, HOOK-UP, OLY 00677964066726 2-8-513 ASSY HOOKUP OLY 4K ESOPHA 00677964102394 2-8-522 ASSY, FUJINON
4K-JET 40677964025387 2-8-523 ASSY, HKUP, FUJI 4K SER 5 00677964074158 2-8-526 ASSY, HOOKUP FUJI 4K+JET 00677964071904 2-8-527 ASSY, FUJI 700 NO FWJ 00677964111648 2-8-528 HOOK
EI-580BT 40677964025394 2-8-534 ASSY, HOOK-UP, PEN-4K+JET 00677964073632 2-8-537 ASSY, HKUP, PTX90 4K+JET 00677964068492 2-8-539 HOOK, PTX I20 FWJ 40677964039827 2-8-540 ASSY-HOOK-UP,STORZ,5K 00677964091223 2-8-611 ASSY, HOOK-UP, OLY 00677964066719 2-8-612 ASSY, HOOKUP, PENTAX 00677964073571 2-8-614 ASM HU OLY
TGF-UC180J 00677964101984 2-8-617 ASSY, HKUP, OLY 2 BIOPSY 00677964073427 2-8-623 ASSY,HKUP,FUJI-5 4K+JET 00677964091476 2-8-625 ASSY, HOOKUP
EG-580UT 00677964077678 2-8-626 ASSY, HOOKUP
EG-580UR 00677964077685 2-8-627 ASSY, HKUP, FUJI 700 SER 00677964083006 2-8-634 ASSY, HOOKUP PENTAX DUAL 00677964074189 2-8-639 HOOK
EG3X-J10 40677964006560 2-8-640 ASSY,HOOK-UP STORZ 6K 00677964074417 2-8-711 ASSY, HOOKUP, OLYMPUS 5K 00677964070662 2-8-718 ASSY, HOOKUP, OLY
160/180 00677964070655 2-8-740 ASSY, HOOK-UP, STORZ 00677964102479 2-8-811 ASSY HKUP OLY-ECHO+LIFT 00677964070624 2-8-901 KIT TEE/TOE/RUS HU ADV+ 00677964046926 5-8-010 ASSY, HOOKUP DBL LT 00677964071874 5-8-030 ASSY, HOOKUP 00677964094644 5-8-040 ASSY HOOKUP STORZ 0K DBL 00677964072772 5-8-050 ASSY, HOOKUP, DILATOR 00677964072963 5-8-112 HOOKUP 2-SCOPE
1-K 00677964072307 5-8-190 HOOK DBL, IS, ION 40677964025493 5-8-210 ASSY, HOOKUP 00677964080333 5-8-245 HOOKUP
KARLSTORZ-2K 00677964102493 2-8-001HAN HU ZERO CHANNEL NO LT 00677964064739 2-8-002HAN ADVANTAGE TEST BLOCK 00677964046568 2-8-010HAN ASSEMBLY, HOOK-UP,OLYMPUS 00677964001802 2-8-030HAN ASSY,HOOKUP,PENTAX-OK 00677964037399 2-8-112HAN ASSY, HOOK-UP OLYMPUS 1K 00677964001819 2-8-160HAN ASSY, ADV HOOKUP, WOLF 00677964037443 2-8-210HAN ASSY, HOOK-UP OLYMPUS 2K 00677964001826 2-8-213HAN ASSY, HOOKUP
OLYMPUS-2K 00677964001871 2-8-218HAN ASSY HOOKUP OLY 2K 00677964061707 2-8-245HAN ASSY, HOOKUP
STORZ-2K 00677964037511 2-8-330HAN ASSY, HOOK-UP
PENTAX-3K 00677964001970 2-8-334HAN ASSEMBLY, HOOK-UP, PENTAX 00677964001994 2-8-335HAN ASSY,HOOKUP,OLYMPUS 00677964037634 2-8-336HAN ASSY,HKUP FUJI 70 BRONC 00677964045387 2-8-338HAN ASSY, HU, FUJI BRONCH U/S 00677964053443 2-8-421HAN ASSY, HOOKUP, FUJINON 00677964037658 2-8-428CAS HOOK, CAS
ED-580XX 40677964024663 2-8-428HAN HOOK, HAN
Page 1 of 2
Amount recalled: 2545 US; 992 OUS

Where it was sold

Nationwide

Why it was recalled

Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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49 in total.

All recall categories · Browse the whole archive

Model / number	Barcodes	Product as published
`PENTAX-0K`	`00677964071348`	2-8-040 ASSY, HKUP STORZ 0K 00677964072284 2-8-070 ASSY, HU VISION SCIENCE 00677964094637 2-8-112 ASSY, HOOKUP OLMPUS 1K 00677964071300 2-8-120 ASSY, HOOKUP FUJI 1K 00677964102080 2-8-210 ASSY, HOOK-UP OLYMPUS 2K 00677964068485 2-8-213 ASSY, HOOKUP
`OLYMPUS-2K`	`00677964070648`	2-8-218 ASSY HOOKUP OLY 2K 00677964072369 2-8-236 ASSY, HOOKUP FUJINON 2K 00677964072376 2-8-244 ASSY, HOOKUP, STORZ 2K 00677964071836 2-8-245 ASSY, HOOK-UP, STORZ 2K 00677964071195 2-8-246 ASSY, HKUP
`PENTAX-2K`	`00677964084058`	2-8-260 ASSY, HOOK-UP WOLF
`2-K`	`00677964105951`	2-8-280 ASSY HOOKUP 00677964073069 2-8-312 ASSY, HOOK-UP
`OLYMPUS-3K`	`00677964074400`	2-8-330 ASSY, HOOK-UP
`PENTAX-3K`	`00677964073816`	2-8-332 ASSEMBLY, HOOK-UP, PENTAX 00677964091483 2-8-334 ASSEMBLY, HOOK-UP, PENTAX 00677964073830 2-8-335 ASSY, HOOKUP, OLYMPUS, 3K 00677964071263 2-8-336 ASSY,HKUP FUJI 70 BRONC 00677964091506 2-8-338 ASSY, HU, FUJI BRONCH U/S 00677964074141 2-8-421 ASSY, HOOKUP, FUJIFILM 00677964071270 2-8-428 ASSY
`ED-580XX`	`00677964104923`	2-8-431 ASSY, HOOKUP, PENTAX 00677964071706 2-8-432 ASSY, HOOK-UP, PENTAX 00677964072239 2-8-460 HOOKUP, ASSY WOLF 4K 00677964092756 2-8-511 ASSY, HOOK-UP, OLY 00677964066726 2-8-513 ASSY HOOKUP OLY 4K ESOPHA 00677964102394 2-8-522 ASSY, FUJINON
`4K-JET`	`40677964025387`	2-8-523 ASSY, HKUP, FUJI 4K SER 5 00677964074158 2-8-526 ASSY, HOOKUP FUJI 4K+JET 00677964071904 2-8-527 ASSY, FUJI 700 NO FWJ 00677964111648 2-8-528 HOOK
`EI-580BT`	`40677964025394`	2-8-534 ASSY, HOOK-UP, PEN-4K+JET 00677964073632 2-8-537 ASSY, HKUP, PTX90 4K+JET 00677964068492 2-8-539 HOOK, PTX I20 FWJ 40677964039827 2-8-540 ASSY-HOOK-UP,STORZ,5K 00677964091223 2-8-611 ASSY, HOOK-UP, OLY 00677964066719 2-8-612 ASSY, HOOKUP, PENTAX 00677964073571 2-8-614 ASM HU OLY
`TGF-UC180J`	`00677964101984`	2-8-617 ASSY, HKUP, OLY 2 BIOPSY 00677964073427 2-8-623 ASSY,HKUP,FUJI-5 4K+JET 00677964091476 2-8-625 ASSY, HOOKUP
`EG-580UT`	`00677964077678`	2-8-626 ASSY, HOOKUP
`EG-580UR`	`00677964077685`	2-8-627 ASSY, HKUP, FUJI 700 SER 00677964083006 2-8-634 ASSY, HOOKUP PENTAX DUAL 00677964074189 2-8-639 HOOK
`EG3X-J10`	`40677964006560`	2-8-640 ASSY,HOOK-UP STORZ 6K 00677964074417 2-8-711 ASSY, HOOKUP, OLYMPUS 5K 00677964070662 2-8-718 ASSY, HOOKUP, OLY
`160/180`	`00677964070655`	2-8-740 ASSY, HOOK-UP, STORZ 00677964102479 2-8-811 ASSY HKUP OLY-ECHO+LIFT 00677964070624 2-8-901 KIT TEE/TOE/RUS HU ADV+ 00677964046926 5-8-010 ASSY, HOOKUP DBL LT 00677964071874 5-8-030 ASSY, HOOKUP 00677964094644 5-8-040 ASSY HOOKUP STORZ 0K DBL 00677964072772 5-8-050 ASSY, HOOKUP, DILATOR 00677964072963 5-8-112 HOOKUP 2-SCOPE
`1-K`	`00677964072307`	5-8-190 HOOK DBL, IS, ION 40677964025493 5-8-210 ASSY, HOOKUP 00677964080333 5-8-245 HOOKUP
`KARLSTORZ-2K`	`00677964102493`	2-8-001HAN HU ZERO CHANNEL NO LT 00677964064739 2-8-002HAN ADVANTAGE TEST BLOCK 00677964046568 2-8-010HAN ASSEMBLY, HOOK-UP,OLYMPUS 00677964001802 2-8-030HAN ASSY,HOOKUP,PENTAX-OK 00677964037399 2-8-112HAN ASSY, HOOK-UP OLYMPUS 1K 00677964001819 2-8-160HAN ASSY, ADV HOOKUP, WOLF 00677964037443 2-8-210HAN ASSY, HOOK-UP OLYMPUS 2K 00677964001826 2-8-213HAN ASSY, HOOKUP
`OLYMPUS-2K`	`00677964001871`	2-8-218HAN ASSY HOOKUP OLY 2K 00677964061707 2-8-245HAN ASSY, HOOKUP
`STORZ-2K`	`00677964037511`	2-8-330HAN ASSY, HOOK-UP
`PENTAX-3K`	`00677964001970`	2-8-334HAN ASSEMBLY, HOOK-UP, PENTAX 00677964001994 2-8-335HAN ASSY,HOOKUP,OLYMPUS 00677964037634 2-8-336HAN ASSY,HKUP FUJI 70 BRONC 00677964045387 2-8-338HAN ASSY, HU, FUJI BRONCH U/S 00677964053443 2-8-421HAN ASSY, HOOKUP, FUJINON 00677964037658 2-8-428CAS HOOK, CAS
`ED-580XX`	`40677964024663`	2-8-428HAN HOOK, HAN