17 results · 12ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.

FDA Recall
Terminated ·Medspira, Llc·Product code GBT·June 14, 2017

Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3) TOWEL ABSORBENT 15 X 20 LIF (10) GAUZE SPONGE 4 X 4 16PLY XRD LIF (1) SYRINGE EAR/ULCER 2oz. LIF (1) DRAPE ABDOMINAL WITH TAPE 40X54 LIF (2) LEGGINS W/7'' CUFF 30X42 L/F (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (1) OB PAD WRAP OVERNIGHT (1) TABLE COVER REINFORCED 50X90 LIF (1) DRAPE UNDERBUTTOCK W/POUCH 44X35" (1) CLAMP UMBILICAL CORD LIF (1) BOWL PLASTIC 80oz. LIF (1) LID FOR BOWL 80oz. CLEAR LIF (1) BEANNIES BABY (5) LAP SPONGE PREWASH 18X18XRD (1) MAYO TRAY SMALL (1) DRAPE SHEET 41X58 SMS LIF (1) UNDERPAD 36X36 BEIGE (1) VAGINAL PACKING XRD 4X36 8PLY 100% COTTON (10) GAUZE SPONGE 4X4 16PLY LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·May 20, 2014

LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

FDA Recall
Terminated ·Centers For Disease Control and Prevention·Product code OZE·April 26, 2024

Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations

FDA Recall
Terminated ·Pentax Medical Company·Product code EOB·April 6, 2016

Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.

FDA Recall
Terminated ·Vision-Sciences, Inc.·Product code EOB·December 27, 2011

ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

FDA Recall
Terminated ·Olympus Corporation of the Americas·Product code EOB·May 5, 2020

Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.

FDA Recall
Terminated ·Vision-Sciences, Inc.·Product code EOB·December 27, 2011

Sterile Custom Packs to be used in surgical procedures.

FDA Recall
Terminated ·American Contract Systems Jackson Pointe Commerce·Product code FBO·April 13, 2020

Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control Box (DCB). Each component is sold separately. Catalog Numbers: PC4180933, SSR181128, CPL100252, PC4181647, SSR181640, CPL100404, DFS100254, SSR181230, CPL100406, DFS100410, DPL100206, SRC141230, CRC140304, DFS100716, CRC140406, CPL100203, DFS100204, DPL100408, SSR100253, PC4181240, DPL100202, CDF100408, PC4181137, CSP100500, CDF100154, PC4180830, CSP100350, DFS100152, SRC140408, PC4181034, CPL100206, CDF100152, SRC141025, SRC140225, CPL100304, CRC141025, CPL 100254, PC4181447, DPL100252, DFS100154, SRC140303, DFS100720, DPL 100204, PC4181343, CSP180500, DFS1 0031 0, DPL100306, DPL100256, CPL100306, CDF100304, CDF100203, CDF100410, PC4100412, DPL 100254, DPL 100053, PC41 00626, CDF100208, CRC140306, PC4100517, DFS100203, CSP181400, CPL 100152, DFS100210, CDF100720, CPL100204, CSP180200, DFS100204, CDF100510, DFS101025, DFS100408, PC41 00730, SSR181740, CRC140615, CPL100256, CDF100206, DFS100308, CPL100151, CSP100200, CDF100616, CRC140711, SSR181334, CDF100310, SRC140445, DFS100252, CPL100408, CDF100306, DFS100250, DPL 100152, DPL 100201, CDF100258, SRC140306, CDF100156, DPL 100153, DPL100304, SRC140922, SSR100825, DFS100206, DPL 100203, PC4181550, DFS100616, CSP180900, PC4181950, DFS100406, SRC140717, PC4181750, DFS100925, CSP100400, PC4181846, SRC140711, CPL100153, PC4182050, DFS100306, SRC140406, CSP100900, SRC140615, CDF100308, CSP100300, DFS1 0051 0, CDF100406, CDF1 0021 0, DFS100156, CDF100515, DPL100151, CDF100925, SSR181028, CDF101025, SSR181540, CPL 100201, SSR180825, CPL 100202; Manufactured and distributed by Micrus Endovascular Corporation, San Jose, CA

FDA Recall
Terminated ·Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131 821 Fox Ln San Jose CA 95131-1601·Product code HCG·October 21, 2010