96 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11) 75CT-B; 12) 75CT-BR; 13) 75CX-B; 14) 75-HCA-CTB; 15) 75-HCA-MTB; 16) 75ME-B; 17) 75MT-B; 18) 75MT-BR; 19) 75MX-B; 20) 75RE-B; 21) 75RT-B; 22) 75WE-B; 23) 75WT-B.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code MHX·March 21, 2025
cobas infinity central lab, Material Number 07154003001
FDA Recall
Open, Classified
·Roche Diagnostics Operations, Inc.·Product code JQP·December 12, 2022
6 cm Catheter Reservoir with 10 cm extension
FDA Recall
Terminated
·Vygon Neuro·Product code HCA·March 24, 2005
Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one INS-HITH Cranial Access Kit, one Sodium Chloride 10 ml, and one Suture 2-0 silk.
FDA Recall
Terminated
·Integra Life Sciences Corp.·Product code HCA·March 19, 2003
Codman Holter Salmon Rickham Reservoir with Ventricular Catheter Catalog Number: 82-1617
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code HCA·March 11, 2004
7 cm Catheter Reservoir with 10 cm extension
FDA Recall
Terminated
·Vygon Neuro·Product code HCA·March 24, 2005
10 cm Scopable Catheter Reservoir
FDA Recall
Terminated
·Vygon Neuro·Product code HCA·March 24, 2005
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HCA·March 17, 2021
Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1
FDA Recall
Open, Classified
·ARROW INTERNATIONAL, LLC·Product code DQX·April 21, 2026
Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non sterile, single patient use, disposable device.
FDA Recall
Terminated
·Beevers Manufacturing & Supply, Inc.·Product code BZD·January 18, 2007
DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.
FDA Recall
Terminated
·Express Diagnostics Int'l., Inc.·Product code MGX·November 21, 2014
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
FDA Recall
Open, Classified
·GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no.·Product code IYN·September 6, 2023
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Recall
Open, Classified
·Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6
Xiangshan Dist.
Hsinchu City Taiwan·Product code PTC·October 4, 2023
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Recall
Open, Classified
·Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6
Xiangshan Dist.
Hsinchu City Taiwan·Product code PTC·October 4, 2023
Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010
American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016
American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016
SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024
American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016
American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016