81 results · 20ms · Sources: EU EUDAMED, US FDA

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Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia

FDA Recall
Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia

FDA Recall
Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia

FDA Recall
Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

FDA Recall
Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 4, 2024

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

FDA Recall
Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 4, 2024

Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier

FDA Recall
Open, Classified ·Breas Medical, Inc.·Product code NOU·June 2, 2022

Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile; (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile; (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile; (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile; (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile; (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile; (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile; (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile; (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile; (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile; (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile; (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile; (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile; (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile; (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile; (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile; (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile; (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile; (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile; (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile; (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile; (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile; (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile; (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile; (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile; (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile; (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile; (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile; (32) Presource EVAR, Cat. SCV30EVTHE, Trillium Health Centre, Sterile; (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile; (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code OEZ·August 16, 2023

MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010

FDA Recall
Open, Classified ·KOB GmbH Lauterstr. 50 Wolfstein Germany·Product code ITG·January 15, 2026

INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

FDA Recall
Open, Classified ·PHASE SCIENTIFIC INTERNATIONAL LIMITED 1/f, E Phase 3 Hong Kong Science Park Sha Tin Hong Kong SAR·Product code QMN·October 25, 2023

ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)

FDA Recall
Open, Classified ·Sklar Instruments·Product code KCG·December 3, 2024

Pediatric care bed; Product Designation: KayserBett IDA;

FDA Recall
Open, Classified ·KAYSERBETTEN GMBH & CO. KG Rieper Str. 12 Bad Fallingbostel Germany·Product code FNL·May 4, 2026

Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.

FDA Recall
Open, Classified ·Macherey Nagel Gmbh & Co. Kg Valencienner Str. 11 Duren Germany·Product code JIL·April 4, 2024

Alinity ci Level Sensor, Bulk Solution

FDA Recall
Open, Classified ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·September 16, 2019

Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution

FDA Recall
Open, Classified ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·September 16, 2019

LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkhausenweg 10 Hamburg Germany·Product code LXH·September 11, 2024

Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution

FDA Recall
Open, Classified ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·September 16, 2019

ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

FDA Recall
Open, Classified ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code LCD·April 24, 2020

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