18 results · 13ms · Sources: EU EUDAMED, US FDA

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IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA

FDA Recall
Open, Classified ·IMPRIS Imaging Inc·Product code LNH·September 30, 2025

Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

FDA Recall
Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

FDA Recall
Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

FDA Recall
Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

Penner Pacific Bathing Spa, Model Numbers 860010-1L

FDA Recall
Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

FDA Recall
Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

Penner Pacific Bathing Spa, Model Numbers 360020-1EP

FDA Recall
Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

Penner Pacific Bathing Spa, Model Numbers 360020-1P

FDA Recall
Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1

FDA Recall
Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2

FDA Recall
Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL

FDA Recall
Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X

FDA Recall
Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

FDA Recall
Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB

FDA Recall
Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWS·July 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code LWS·July 7, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code NIK·July 7, 2022

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002; c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ82989; d. SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267; e. TV IR PICC PACK-LF, Model Number: DYNJ41561D; f. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635A; g. ULTRASOUND GUIDED PIV KIT, Model Number: DYNDA2669; h. USG PIV INSERTION KIT, Model Number: DYNDV2480; i. VASCULAR, Model Number: DYNJ907965; j. VASCULAR ACCESS, Model Number: DYNJ901340A; k. VASCULAR ACCESS TRAY, Model Number: DYNJ52606B; l. VASCULAR ACCESS-LF, Model Number: DYNJ905285D; m. VASCULAR ENDO LASER PK, Model Number: DYNJ37445G; n. VASCULAR PACK, Model Number: DYNJ66356F; o. VASCULAR VEIN PACK, Model Number: DYNJ69769; p. VEIN ABLATION, Model Number: DYNJ63268C, DYNJ63268D, DYNJ66079A; q. VEIN ABLATION KIT, Model Number: DYNJ69272; r. VEIN ABLATION PACK, Model Number: DYNJ62889A, DYNJ62889B, DYNJ69288; s. VEIN ABLATION PLUS W CHL, Model Number: DYNJ67115A; t. VEIN CLOSURE, Model Number: DYNJ49180A; u. VEIN CLOSURE PACK, Model Number: DYNJ69976, DYNJ69976A, DYNJ81834; v. VEIN CLOSURE TRAY - NIVC, Model Number: DYNJ44737C; w. VEIN HARVESTING PACK, Model Number: DYNJ82933; x. VEIN LIGATION, Model Number: DYNJ64190B; y. VEIN OHH, Model Number: DYNJ65560C; z. VEIN PACK, Model Number: DYNJ66743B, DYNJ69091A, DYNJ69091B, DYNJ69177, DYNJ69942, DYNJ69942A, DYNJ81120, DYNJ81212A, DYNJ83914; aa. VEIN PACK-LF, Model Number: DYNJ66271B, DYNJ66271D; bb. VEIN PROCEDURE PACK, Model Number: DYNJ62038B, DYNJ81177; cc. VEIN PROCEDURE TRAY, Model Number: DYNJ82581; dd. VENCLOSE PROCEDURE PACK 7CM, Model Number: VC-PPH-6F7A; ee. VENCLOSE PROCEDURE PACK MAVEN, Model Number: VC-PPM-12F; ff. VENCLOSE PROCEDURE PACK, 12CM, Model Number: VC-PP-6F12, VC-PPH-6F12A; gg. VENOUS ABLATION, Model Number: DYNJ44904B, DYNJ44904C; hh. VENOUS ACCESS, Model Number: DYNJ59751B; ii. VENOUS ACCESS PACK, Model Number: DYNJ44421B; jj. VENOUS ACCESS TRAY, Model Number: DYNJ20094L; kk. VENOUS LIGATION PACK, Model Number: DYNJ43981G; ll. VENOUS PACK, Model Number: DYNJ43168, DYNJ43168A, DYNJ43168B, DYNJ56260A, DYNJ56447B, DYNJ62711A, DYNJ66499A, DYNJ66499B, DYNJ80169, DYNJ80169A, DYNJ80692; mm. VNUS PACK, Model Number: DYNJ59246A; nn. WEST VALLEY PICC LINE PACK, Model Number: DYNJ43975A;

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