3,231 results · 18ms · Sources: EU EUDAMED, US FDA

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Stanley Bed-Check 30-Day IT Chair Sensormat, With 8 Ft. Cord, Model 73010, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. For use in reducing patient falls.

FDA Recall
Terminated ·Stanley Security Solutions, Inc.·Product code KMI·November 25, 2009

Stanley Bed-Check 30-Day IT Bed Sensormat, With 8 Ft. Cord, Model 74010, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. For use in reducing patient falls.

FDA Recall
Terminated ·Stanley Security Solutions, Inc.·Product code KMI·November 25, 2009

Stanley Bed-Check 90-Day LT Bed Sensormat, With 8 Ft. Cord, Model 74011, 5 mats per inner box, 5 inner boxes per overpack box (total 25 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. For use in reducing patient falls.

FDA Recall
Terminated ·Stanley Security Solutions, Inc.·Product code KMI·November 25, 2009

Stanley Bed-Check 30-Day IT Bed Sensormat, With 5.5 Ft. Cord, Model 74000, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. For use in reducing patient falls.

FDA Recall
Terminated ·Stanley Security Solutions, Inc.·Product code KMI·November 25, 2009

SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/ introducer and wings (25/box); 6. Sprotte 21G x 103mm w/ introducer and wings (25/box); 7. Sprotte 20G x 103mm w/ introducer and wings (25/box); 8. Sprotte 20G x 90mm w/ introducer and wings (25/box) Product Usage: The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients.

FDA Recall
Open, Classified ·Pajunk GmbH Karl-hall-str. 1 Geisingen Germany·Product code BSP·August 30, 2019

(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112

FDA Recall
Open, Classified ·Biomet, Inc.·Product code JWH·December 29, 2022

Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

FDA Recall
Terminated ·Orthofix Srl Via Delle Nazioni 9 Bussolengo Italy·Product code KTT·July 5, 2017

EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code FDT·September 27, 2023

EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code PIF·February 10, 2026

Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth, stock code 5000052, packaged in single unit blister packs, 200 per box, 6 boxes per carton, stock code 5000101, packaged in single unit blue cap packaging, 100 per box, and stock code 5000115, packaged in single unit blue cap packaging, 200 per box; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089

FDA Recall
Terminated ·Efoora, Inc. dba Virotek, L.L.C.·Product code FMK·May 5, 2005

Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX

FDA Recall
Terminated ·CooperSurgical, Inc.·Product code MPO·July 6, 2015

1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1690-001 (1 unit per pouch/30 per box); 1690-003 (3 units per pouch/30 per box); 1690-005 (5 units per pouch/50 per box); 1690-010 (50 units per pouch/no box/ 1000 per case); 1690-030 (30 units per pouch/no box). The above are sold in boxes of 600 with the exception of 1690-010 (sold 1000 per case) as noted above. Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York

FDA Recall
Terminated ·Conmed Corporation·Product code DRX·July 30, 2003

Radiomat SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet Box

FDA Recall
Terminated ·AGFA Corp.·Product code JAC·February 16, 2006

1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

FDA Recall
Open, Classified ·Remel, Inc·Product code JTZ·November 12, 2025

Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.

FDA Recall
Terminated ·Becton Dickinson & Co.·Product code JTZ·July 28, 2005

DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

FDA Recall
Terminated ·Derma Pen, LLC·Product code PIU·February 5, 2015

MediSense Precision QID Blood Glucose Test Strips. The product is sold in box of 50 and 100. The NDC number for the 50 count box is 57599-7400-4. The NDC number for the 100 count box is 57599-7401-5.

FDA Recall
Terminated ·AmeriSource Bergen·Product code CGA·January 30, 2004

10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

FDA Recall
Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FMF·August 8, 2023

ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged as follows: UPN: (1)Twin Pack Box 1 M00519200 (2)Twin Pack Box 10 M00519201 (3)Single Pack Box 1 M00519220 (4)Single Pack Box 10 M00519221

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code PLL·October 10, 2022

3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

FDA Recall
Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FMF·August 8, 2023