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GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

FDA Recall
Open, Classified ·GE Healthcare·Product code LLZ·August 5, 2024

155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 169-101 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 139122-01 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 155160-01 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 169-102 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 138912-01 BD PYXIS MEDBANK MINI 1HH-3HM 155161-01 BD PYXIS MEDBANK MINI 1HH-3HM 169-103 BD PYXIS MEDBANK MINI 1HH-3HM 138902-01 BD PYXIS MEDBANK MINI 2FH 169-104 BD PYXIS MEDBANK MINI 2FH 138903-01 BD PYXIS MEDBANK MINI 2FM 155163-01 BD PYXIS MEDBANK MINI 2FM 169-105 BD PYXIS MEDBANK MINI 2FM 138908-01 BD PYXIS MEDBANK MINI 2HH-1FH 169-106 BD PYXIS MEDBANK MINI 2HH-1FH 138906-01 BD PYXIS MEDBANK MINI 2HH-1FM 155165-01 BD PYXIS MEDBANK MINI 2HH-1FM 169-107 BD PYXIS MEDBANK MINI 2HH-1FM 138907-01 BD PYXIS MEDBANK MINI 2HH-2HM 155166-01 BD PYXIS MEDBANK MINI 2HH-2HM 169-108 BD PYXIS MEDBANK MINI 2HH-2HM 139131-01 BD PYXIS MEDBANK MINI 2HM-1FM 155167-01 BD PYXIS MEDBANK MINI 2HM-1FM 169-109 BD PYXIS MEDBANK MINI 2HM-1FM 139091-01 BD PYXIS MEDBANK MINI 3HH-1FG 155168-01 BD PYXIS MEDBANK MINI 3HH-1FG 169-110 BD PYXIS MEDBANK MINI 3HH-1FG 138909-01 BD PYXIS MEDBANK MINI 3HH-1HM 155169-01 BD PYXIS MEDBANK MINI 3HH-1HM 169-111 BD PYXIS MEDBANK MINI 3HH-1HM 138910-01 BD PYXIS MEDBANK MINI 4HH 155310-01 BD PYXIS MEDBANK MINI 4HH 169-112 BD PYXIS MEDBANK MINI 4HH 138915-01 BD PYXIS MEDBANK MINI 4HM 155171-01 BD PYXIS MEDBANK MINI 4HM 169-113 BD PYXIS MEDBANK MINI 4HM 1147-00 MEDBANK MINI MAIN 138943-01 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 155081-01 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 169-23 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 138955-01 BD PYXIS MEDBANK TWR MN 10HH-2FH 155082-01 BD PYXIS MEDBANK TWR MN 10HH-2FH 169-24 BD PYXIS MEDBANK TWR MN 10HH-2FH 138924-01 BD PYXIS MEDBANK TWR MN 10HH-2FM 155083-01 BD PYXIS MEDBANK TWR MN 10HH-2FM 169-25 BD PYXIS MEDBANK TWR MN 10HH-2FM 138960-01 BD PYXIS MEDBANK TWR MN 12HH-1FF 155084-01 BD PYXIS MEDBANK TWR MN 12HH-1FF 169-26 BD PYXIS MEDBANK TWR MN 12HH-1FF 138961-01 BD PYXIS MEDBANK TWR MN 12HH-1FH 155085-01 BD PYXIS MEDBANK TWR MN 12HH-1FH 169-27 BD PYXIS MEDBANK TWR MN 12HH-1FH 138926-01 BD PYXIS MEDBANK TWR MN 12HH-1FM 155086-01 BD PYXIS MEDBANK TWR MN 12HH-1FM 169-28 BD PYXIS MEDBANK TWR MN 12HH-1FM 138927-01 BD PYXIS MEDBANK TWR MN 14HH 155087-01 BD PYXIS MEDBANK TWR MN 14HH 169-29 BD PYXIS MEDBANK TWR MN 14HH 155293-01 BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM 169-138 BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM 155303-01 BD PYXIS MEDBANK TWR MN 1FM-10HH-1FH 139082-01 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 155088-01 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 169-30 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 155305-01 BD PYXIS MEDBANK TWR MN 2FH-1FM-4HH-2FM 139056-01 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 155089-01 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 169-31 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 155304-01 BD PYXIS MEDBANK TWR MN 2FM-8HH-1FH 139045-01 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 155090-01 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 169-32 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 138932-01 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 155091-01 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 169-33 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 139084-01 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 155092-01 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 169-34 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 138963-01 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 155093-01 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 169-35 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 155294-01 BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM 169-139 BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM 138938-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 155094-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 169-36 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 139125-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 155095-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 169-37 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 138919-01 BD PYXIS MEDBANK TWR MN 2HH-6FM 155096-01 BD PYXIS MEDBANK TWR MN 2HH-6FM 169-38 BD PYXIS MEDBANK TWR MN 2HH-6

FDA Recall
Open, Classified ·CareFusion 303, Inc.·Product code BRY·January 8, 2025

Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-2HM/169-108, BD PYXIS MEDBANK MINI 2HH-1FM/169-107, BD PYXIS MEDBANK MINI 2HH-1FH/169-106, BD PYXIS MEDBANK MINI 2FM/169-105, BD PYXIS MEDBANK MINI 2FH/169-104, BD PYXIS MEDBANK MINI 1HH-3HM/169-103, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/169-102, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/169-101 , BD PYXIS MEDBANK MINI 1FH-2HH/155311-01, BD PYXIS MEDBANK MINI 4HH/155310-01, BD PYXIS MEDBANK MINI 1FH-1FM/155288-01, BD PYXIS MEDBANK MINI 4HM/155171-01, BD PYXIS MEDBANK MINI 3HH-1HM/155169-01, BD PYXIS MEDBANK MINI 3HH-1FG/155168-01, BD PYXIS MEDBANK MINI 2HM-1FM/155167-01, BD PYXIS MEDBANK MINI 2HH-2HM/155166-01, BD PYXIS MEDBANK MINI 2HH-1FM/155165-01, BD PYXIS MEDBANK MINI 2FM/155163-01, BD PYXIS MEDBANK MINI 1HH-3HM/155161-01, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/155160-01, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/155159-01, BD PYXIS MEDBANK MINI 2HM-1FM/139131-01, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/139122-01, BD PYXIS MEDBANK MINI 3HH-1FG/139091-01, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/138921-01, BD PYXIS MEDBANK MINI 4HM/138915-01, BD PYXIS MEDBANK MINI 1HH-3HM/138912-01, BD PYXIS MEDBANK MINI 4HH/138910-01, BD PYXIS MEDBANK MINI 3HH-1HM/138909-01, BD PYXIS MEDBANK MINI 2HH-1FH/138908-01, BD PYXIS MEDBANK MINI 2HH-2HM/138907-01, BD PYXIS MEDBANK MINI 2HH-1FM/138906-01, BD PYXIS MEDBANK MINI 2FM/138903-01, BD PYXIS MEDBANK MINI 2FH/138902-01, MEDBANK MINI MAIN/1147-00, MEDBANK MAIN/1137-00, BD PYXIS MEDBANK TWR MN 8HH-3FM/169-81, BD PYXIS MEDBANK TWR MN 8HH-3FH/169-80, BD PYXIS MEDBANK TWR MN 8HH-3FF/169-79, BD PYXIS MEDBANK TWR MN 8HH-2HM-2FM/169-78, BD PYXIS MEDBANK TWR MN 8HH-2FH-1FM/169-77, BD PYXIS MEDBANK TWR MN 8HH-1FH-2HM-1FM/169-76, BD PYXIS MEDBANK TWR MN 8HH-1FH-2FM/169-75, BD PYXIS MEDBANK TWR MN 7HH-1HM-3FM/169-74, BD PYXIS MEDBANK TWR MN 7FM/169-73, BD PYXIS MEDBANK TWR MN 7FH/169-72, BD PYXIS MEDBANK TWR MN 6HH-8HM/169-71, BD PYXIS MEDBANK TWR MN 6HH-6HM-1FM/169-70, BD PYXIS MEDBANK TWR MN 6HH-4HM-2FM/169-69, BD PYXIS MEDBANK TWR MN 6HH-4FM/169-68, BD PYXIS MEDBANK TWR MN 6HH-4FH /169-67, BD PYXIS MEDBANK TWR MN 6HH-2FH-2HM-1FM/169-66, BD PYXIS MEDBANK TWR MN 6HH-2FH-2FM/169-65, BD PYXIS MEDBANK TWR MN 6HH-1FH-3FM/169-64, BD PYXIS MEDBANK TWR MN 6HH-1FH-2HM-2FM/169-63, BD PYXIS MEDBANK TWR MN 6FH-1FM/169-62, BD PYXIS MEDBANK TWR MN 5HH-9HM/169-61, BD PYXIS MEDBANK TWR MN 5HH-3HM-3FM/169-60, BD PYXIS MEDBANK TWR MN 4HM-5FM/169-59, BD PYXIS MEDBANK TWR MN 4HH-8HM-1FM/169-58, BD PYXIS MEDBANK TWR MN 4HH-6HM-2FM/169-57, BD PYXIS MEDBANK TWR MN 4HH-5FM/169-56, BD PYXIS MEDBANK TWR MN 4HH-5FH /169-55, BD PYXIS MEDBANK TWR MN 4HH-4HM-3FM/169-54, BD PYXIS MEDBANK TWR MN 4HH-4FH-1FM/169-53, BD PYXIS MEDBANK TWR MN 4HH-3FH-2FM/169-52, BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM/169-51, BD PYXIS MEDBANK TWR MN 4HH-2FH-3FM/169-50, BD PYXIS MEDBANK TWR MN 4HH-2FH-2HM-2FM/169-49, BD PYXIS MEDBANK TWR MN 4HH-1FH-6HM-1FM/169-48, BD PYXIS MEDBANK TWR MN 4HH-1FH-4HM-2FM/169-47, BD PYXIS MEDBANK TWR MN 4HH-1FH-4FM/169-46, BD PYXIS MEDBANK TWR MN 4HH-1FH-2HM-3FM/169-45, BD PYXIS MEDBANK TWR MN 4HH-10HM/169-44, BD PYXIS MEDBANK TWR MN 3HH-7HM-2FM/169-43, BD PYXIS MEDBANK TWR MN 3FH-4FM/169-42, BD PYXIS MEDBANK TWR MN 2HM-6FM/169-41, BD PYXIS MEDBANK TWR MN 2HH-8HM-2FM/169-40, BD PYXIS MEDBANK TWR MN 2HH-6HM-3FM/169-39, BD PYXIS MEDBANK TWR MN 2HH-6FM/169-38, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM/169-37, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF/169-36, BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF/169-35, BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM/169-34, BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM/169-33, BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM/169-32, BD PY

FDA Recall
Open, Classified ·CareFusion 303, Inc.·Product code BRY·July 10, 2025

BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI 2HH-1FM, 138906-01; MINI 3HH-1FG, 169-110; MINI 3HH-1FG, 139091-01; MINI 3HH-1HM, 169-111; MINI 4HH, 138910-01; MINI 4HH, 169-112; MINI 4HM, 169-113; MINI 4HM, 138915-01; TWR MN 10HH-1FH-1FM, 169-23; TWR MN 10HH-2FH, 169-24; TWR MN 10HH-2FH, 138955-01; TWR MN 10HH-2FM, 169-25; TWR MN 10HH-2FM, 138924-01; TWR MN 12HH-1FF, 169-26; TWR MN 12HH-1FF, 138960-01; TWR MN 12HH-1FH, 169-27; TWR MN 12HH-1FH, 138961-01; TWR MN 12HH-1FM, 169-28; TWR MN 12HH-1FM, 138926-01; TWR MN 14HH, 138927-01; TWR MN 14HH, 169-29; TWR MN 1HH-1HM-2FM-4FF, 169-30; TWR MN 2FH-2HM-4FM, 169-31; TWR MN 2HH-10HM-1FM, 169-32; TWR MN 2HH-1FH-5FM, 169-33; TWR MN 2HH-2FH-4FM, 169-34; TWR MN 2HH-4FH-2FM, 169-139; TWR MN 2HH-4HM-4FM, 139125-01; TWR MN 2HH-6FM, 169-38; TWR MN 2HH-6FM, 138919-01; TWR MN 2HH-6HM-3FM, 169-39; TWR MN 2HH-8HM-2FM, 169-40; TWR MN 2HM-6FM, 169-41; TWR MN 3FH-4FM, 169-42; TWR MN 3FH-4FM, 138933-01; TWR MN 3FH-8HH MEDPASS, 169-140; TWR MN 3HH-7HM-2FM, 169-43; TWR MN 4HH-10HM, 169-44; TWR MN 4HH-10HM, 138959-01; TWR MN 4HH-1FH-2HM-3FM, 169-45; TWR MN 4HH-1FH-4FM, 169-46; TWR MN 4HH-1FH-4HM-2FM, 169-47; TWR MN 4HH-2FH-2HM-2FM, 169-49; TWR MN 4HH-2FH-3FM, 169-50; TWR MN 4HH-2FH-3FM, 138931-01; TWR MN 4HH-3FH-2FM, 169-52; TWR MN 4HH-4FH-1FM, 169-53; TWR MN 4HH-4FH-1FM, 138940-01; TWR MN 4HH-4HM-3FM, 169-54; TWR MN 4HH-4HM-3FM, 138952-01; TWR MN 4HH-5FH, 169-55; TWR MN 4HH-5FM, 169-56; TWR MN 4HH-5FM, 138918-01; TWR MN 4HH-6HM-2FM, 169-57; TWR MN 4HM-5FM, 169-59; TWR MN 5HH-3HM-3FM, 169-60; TWR MN 5HH-9HM, 138914-01; TWR MN 5HH-9HM, 169-61; TWR MN 6FH-1FM, 169-62; TWR MN 6HH-1FH-2HM-2FM, 169-63; TWR MN 6HH-1FH-3FM, 169-64; TWR MN 6HH-2FH-2FM, 169-65; TWR MN 6HH-4FH, 169-67; TWR MN 6HH-4FH, 138957-01; TWR MN 6HH-4FM, 169-68; TWR MN 6HH-4FM, 138922-01; TWR MN 6HH-4HM-2FM, 169-69; TWR MN 6HH-8HM, 169-71; TWR MN 6HH-8HM, 138958-01; TWR MN 7FH, 169-72; TWR MN 7FH, 138920-01; TWR MN 7FM, 169-73; TWR MN 7FM, 138937-01; TWR MN 7HH-1HM-3FM, 139086-01; TWR MN 7HH-1HM-3FM, 169-74; TWR MN 8HH-1FH-2FM, 169-75; TWR MN 8HH-2FH-1FM, 169-77; TWR MN 8HH-2HM-2FM, 169-78; TWR MN 8HH-2HM-2FM, 138939-01; TWR MN 8HH-3FF, 169-79; TWR MN 8HH-3FH, 169-80; TWR MN 8HH-3FH, 138956-01; TWR MN 8HH-3FM, 169-81; TWR MN 8HH-3FM, 138923-01. BD PYXIS MEDFLEX MN (Name, REF): 1000 12HH, 139055-01; 1000 2HH-2FM, 139041-01; 1000 2HH-5FM, 139046-01; 1000 4HH-4FM, 139049-01; 1000 6HH-3FM, 139051-01; 1000 8HH-2FM, 139052-01; 2000 8HH-2FH, 139165-01; 2000 8HH-2FM, 139069-01. MEDBANK MAIN, 1137-00; MEDBANK MINI MAIN, 1147-00; MEDBANK TOWER MAIN, 1145-00; MEDFLEX, 1119-00; MEDFLEX 2.0, 1139-00

FDA Recall
Open, Classified ·CareFusion 303, Inc.·Product code BRY·March 11, 2025

Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FKG·November 15, 2023

Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4) DIALYSIS TRAY , Pack Number DT22005; 5) PRE POST DIALYSIS, Pack Number DYNDC3274; 6) MYELOGRAM TRAY, Pack Number DYNDH1531; 7) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301; 8) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 9) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100; 10) LUMBAR PUNCTURE TRAY, Pack Number PT215; 11) FINE LACERATION KIT, Pack Number SUT19360

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FKG·April 8, 2024

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FKG·May 15, 2023

Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FKG·November 15, 2023

Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 18FR (6.0 MM), 5CC, CSD; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 14 FR (4.7 MM), 5CC, 2000ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M TEMP SENSE FOLEY TRAY, 16 FR (5.3 MM), 5 CC; Dover" 100% SILICONE 400 ML U/M TEMP SENSE FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 18 FR (6.0 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 14 FR (4.7 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 16 FR (5.3 MM), 5CC, 2000ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code FFG·December 4, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FKG·May 18, 2023

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

FDA Recall
Open, Classified ·Product code FKG·January 8, 2026

BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-104, MEDBANK MINI 2FM/ 169-105, MEDBANK MINI 2HH-1FH/ 169-106, MEDBANK MINI 2HH-1FM/ 169-107, MEDBANK MINI 2HH-1FM MEDPASS/ 169-152, MEDBANK MINI 2HH-2HM/ 169-108, MEDBANK MINI 2HM-1FM/ 169-109, MEDBANK MINI 3HH-1FG/ 169-110, MEDBANK MINI 3HH-1HM/ 169-111, MEDBANK MINI 4HH/ 169-112, MEDBANK MINI 4HH MEDPASS/ 169-150, MEDBANK MINI 4HM/ 169-113, MEDBANK MINI CR-2HH-1FH-P/ 169-114, MEDBANK MINI CR-4HH-P/ 169-115, MB MINI MAIN CR/ 169-163, MB MINI MAIN W/CUBIE DRWS/ 169-159, MB MINI MAIN W/FH FALSE DRW/ 169-162, MB MINI MAIN W/HH FALSE DRW/ 169-161, MB MINI MAIN W/MATRIX DRWS / 169-160, MB MINI MAIN W/MP/ 169-164 Used with the following user guides: BD Pyxis CUBIE Replenishment Station User Guide (DIR 10000414989), BD Pyxis MedBank Cabinet User Guide (DIR 10000414987), BD Pyxis MedBank Installation and Upgrade Guide (DIR 10000414990)

FDA Recall
Open, Classified ·CareFusion 303, Inc.·Product code BRY·May 13, 2024

Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 24, 2022

MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code LPH·July 14, 2023

SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JDG·February 6, 2024

Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·February 14, 2025

Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·February 14, 2025

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code KRO·March 18, 2021

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code LZO·July 3, 2023

Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7) 880-313/21 (Sz. 3-4 - cemented lg), (8) 880-313/22 (Sz. 3-4 - cemented x-lg), (9) 880-315/11 (Sz. 5-6 - cemented sm), (10) 880-315/12 (Sz. 5-6 - cemented md), (11) 880-315/21 (Sz. 5-6 - cemented lg), (12) 880-315/22 (Sz. 5-6 - cemented x-lg), (13) 880-317/11 (Sz. 7-8 - cemented sm), (14) 880-317/12 (Sz. 7-8 - cemented md), (15) 880-317/21 (Sz. 7-8 - cemented lg), (16) 880-317/22 (Sz. 7-8 - cemented x-lg), (17) 880-319/11 (Sz. 9-10 - cemented sm), (18) 880-319/12 (Sz. 9-10 - cemented md), (19) 880-319/21 (Sz. 9-10 - cemented lg), (20) 880-319/22 (Sz. 9-10 - cemented x-lg).

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·April 3, 2025