BEUDAMED
    34 results · 18ms · Sources: EU EUDAMED, US FDA

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    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

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58344; 5. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJS3016.

    FDA Recall
    Open, Classified ·Product code OKV·March 19, 2026

    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

    Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)

    FDA Recall
    Open, Classified ·Forbes Rehab Services Inc·Product code ILQ·October 11, 2021

    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

    BostonSight SCLERAL Lens

    FDA Recall
    Open, Classified ·Boston Foundation For Sight·Product code HQD·June 10, 2025

    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

    BostonSight PROSE Lens.

    FDA Recall
    Open, Classified ·Boston Foundation For Sight·Product code HQD·June 10, 2025

    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

    11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FBO·April 1, 2022

    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

    CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FBO·April 1, 2022

    11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code EOB·April 1, 2022

    11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FBO·April 1, 2022