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Sources: EU EUDAMED, US FDA
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FDA Recall
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Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HWA·August 28, 2017
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYNDC3184, g) IMPLANTED VASCULAR ACCESS, REF DYNDC2842, h) INFANT COARTATION PACK, REF DYNJ54822D, i) INFANT OPEN HEART PUMP, REF DYNJ904068D, j) INFUSA PORT DRESSING KIT, REF DYNDC3192, k) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165, l) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165B, m) OPEN HEART ACCESSORY CDS, REF CDS984289K, n) PACEMAKER PK SHSC-LF, REF DYNJ46785C, o) PERICARDIAL KIT, REF DYNDA2212B, p) PK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B, q) PUH PERCUTANEOUS ECMO, REF DYNJ907554A, r) PUH PERCUTANEOUS ECMO, REF DYNJ907554C
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·November 15, 2023
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LXH·June 22, 2018
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
FDA Recall
Open, Classified
·Stryker Corporation·Product code NHB·February 25, 2025
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
FDA Recall
Open, Classified
·Stryker Corporation·Product code NHB·February 25, 2025
Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
FDA Recall
Open, Classified
·Medtronic Inc.·Product code MDS·February 26, 2021
Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant into the humeral canal after the fracture has been reduced.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HTY·August 2, 2016
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.
FDA Recall
Terminated
·Water Pik, Inc.·Product code JET·July 2, 2018
Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.
FDA Recall
Terminated
·Water Pik, Inc.·Product code KMA·April 3, 2012
INSTRUMENT TRACKER 9733533XOM ENT 1PK
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
PATIENT TRACKER 9733534XOM ENT 1PK
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
FDA Recall
Terminated
·Tornier, Inc·Product code NWJ·February 8, 2018
NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF (1) INSTRUMENT POUCH (10) LAP SPONGE PRE-WASH XRD (1) Pk. SURGICAL STRIP W' X 6" (2) UTILITY BOWL 32oz (1) MAYO TRAY LARGE (9) SHEET DRAPE 41 " X 69" MEDIUM LIF (1) NEEDLE HYPODERMIC 18G X 1 LIF (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) Pr. SURGICAL GLOVES 7 Y2 (2) Pr. SURGICAL GLOVES 8 (2) EAR ULCER SYRINGE 2oz LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) SHEET MINOR LAP 102" X 121" X 78" (1) SAFETY SCALPEL #10 (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (4) CLOTH HUCK TOWELS BLUE (1) PENCIL CAUTERY ROCKER SWITCH (2) LEGGINS W/7'' CUFF 30" X 42" (1) DRAPE% ECONOMY 53" X 77" LIF (1) Pk. SURGICAL STRIP 'X" X 6" (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (2) ROUND WASH BASIN 6QT (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE (2) Pr. SURGICAL GLOVES 7 (1) SKIN MARKER WITH RULER LIF (1) Pk. STERI STRIP CLOSURE %"X 4" LIF (1) TUBE SUCTION CONNECT. 'X" X 12' LIF (1) SAFETY SCALPEL #15 (1) SAFETY SCALPEL #11L/F 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 OJG·May 20, 2014
Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PK
FDA Recall
Terminated
·Ossur Americas·Product code JEC·June 21, 2018
DISP 9730950 STRL SPHERE, 1 PK INSERT
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
FDA Recall
Open, Classified
·Medtronic Inc.·Product code MDS·February 26, 2021
Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
FDA Recall
Open, Classified
·Medtronic Inc.·Product code MDS·February 26, 2021
Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 00763000318895 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
FDA Recall
Open, Classified
·Medtronic Inc.·Product code MDS·February 26, 2021
Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 00763000414375 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
FDA Recall
Open, Classified
·Medtronic Inc.·Product code MDS·February 26, 2021
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
FDA Recall
Open, Classified
·Stryker Corporation·Product code NHB·February 25, 2025