1,392 results · 18ms · 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.

GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

FDA Recall
Open, Classified ·Ohio Medical Corporation·Product code CAW·May 8, 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

BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

FDA Recall
Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code OGH·November 27, 2019

BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

FDA Recall
Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code CCW·November 27, 2019

Bard Recovery Cone Removal System, Catalog Numbers: RC-15. The device is intended for use for percutaneously remove the recovery filter or facilitate the retrieval of foreign objects from the peripheral vascular system.

FDA Recall
Terminated ·Bard Peripheral Vascular Inc·Product code GAE·May 9, 2008

Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage

FDA Recall
Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA. Indicated for specimen retrieval and therapeutic drainage of the pleural cavity.

FDA Recall
Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code GCB·August 28, 2013

CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986

FDA Recall
Terminated ·Becton Dickinson & Company·Product code GCB·March 26, 2020

Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7'' long Thoracentesis Catheter with a 14 gauge x 2'' needle, catheter guard, 60 ml syringe, needles, 5 ml syringe, drainage tube with needle, fluid collection bag, three prelabeled specimen vials with caps, 2 swab sticks, three gauze pads, fenestrated drape with adhesive strips, towel, 5 ml -1% lidocaine hydrochloride, hospital wrap and bandage; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA

FDA Recall
Terminated ·Cardinal Health 1430 Waukegan Rd ATTN: V. MUELLER QA McGaw Park IL 60085·Product code GCB--·November 15, 2002

Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Catheter, biliary, surgical

FDA Recall
Terminated ·EXP Pharmaceutical Services Corp·Product code GCA·February 11, 2015

- ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25TL Lot 122518 and Lot 123190. -- Arthrex SutureLasso SD, 25 Degree Tight Curve Right, w/Nitinol Wire Loop, (Lt. Green) 1.8mm. REF AR-4068-25TR Lot 122518 and Lot 123190. - Arthrex SutureLasso SD, 90 Degrees (Black) 1.8mm. REF AR-4068-90 Lot 122504. - Arthrex SutureLasso, 45 Degree, Perforating Needle Cannula, w/Suture Loop, (Lt. Grey). REF AR-4065S Lot 122590. -SutureLasso, w/Wire Loop, 90 Degree, (Blue) REF AR-4065-90W Lot 123263. Manual surgical instrument for general use

FDA Recall
Terminated ·Surgical Instrument Service And Savings, Inc.·Product code GAE·May 3, 2013

Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.

FDA Recall
Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, NC 27105.

FDA Recall
Terminated ·Wilson-Cook Medical Inc·Product code GCA·August 28, 2002

Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code GCB·April 26, 2020

Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.

FDA Recall
Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

Bard Recovery Cone Removal System, Catalog Numbers: FBRC. The device is intended for use for percutaneously remove the recovery filter or facilitate the retrieval of foreign objects from the peripheral vascular system.

FDA Recall
Terminated ·Bard Peripheral Vascular Inc·Product code GAE·May 9, 2008

Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.

FDA Recall
Terminated ·Custom Healthcare Systems, Inc.·Product code GCB·November 5, 2014

Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490

FDA Recall
Open, Classified ·Cook Incorporated·Product code GCB·March 1, 2024

Calcium Sulfate Hemihydrate 1.0 gram kits.

FDA Recall
Terminated ·Ace Surgical Supply Co., Inc.·Product code LYC·May 14, 2010

Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

FDA Recall
Terminated ·Ace Surgical Supply Co., Inc.·Product code EMO·March 28, 2018