510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,528 records, page 460 of 1191
FDA device recalls, page 460 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2878-2018Class IWaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523...Biosense Webster IncNGV
Z-2557-2018Class IIcobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The...Roche Diagnostics Hematology, Inc.JOY
Z-2466-2018Class IIPronova Suture Blue 122Cm M1.5, D10189Ethicon, IncGAW
Z-2465-2018Class IIPRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027Ethicon, IncGAW
Z-2464-2018Class IIProlene Suture Blue 18" 7-0 D/a Bv-1, Dc631Ethicon, IncGAW
Z-2463-2018Class IIPROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995Ethicon, IncGAW
Z-2462-2018Class IIProlene Suture 36"(90Cm) 3-0 Blu, D9844Ethicon, IncGAW
Z-2461-2018Class IIProlene Suture Blue 48" 4-0 D/a Sh-1, D9746Ethicon, IncGAW
Z-2460-2018Class IIProlene Suture 4"(10Cm) 8-0 Blue, D9662Ethicon, IncGAW
Z-2459-2018Class IIProlene Suture 36"(90Cm) 4-0 Blue, D9067Ethicon, IncGAW
Z-2458-2018Class IIProlene Suture 24"(60Cm) 7-0 Blue, D8881Ethicon, IncGAW
Z-2457-2018Class IIProlene Suture 24"(60Cm) 6-0 Blue, D8688Ethicon, IncGAW
Z-2456-2018Class IIProlene Suture 30"(75Cm) 6-0 Blue, D8647Ethicon, IncGAW
Z-2455-2018Class IIProlene Suture 30"(75Cm) 8-0 Blue, D8292Ethicon, IncGAW
Z-2454-2018Class IIProlene Suture Blue 4X18"5/0 Da Rb-2 +Plg, D7879Ethicon, IncGAW
Z-2453-2018Class IIProlene Suture 36"(90Cm) 4-0 Blue, D7768Ethicon, IncGAW
Z-2452-2018Class IIProlene Suture 30"(75Cm) 4-0 Blue, D7748Ethicon, IncGAW
Z-2451-2018Class IIProlene Suture 4-36" (90Cm) 3-0 Blue, D6416Ethicon, IncGAW
Z-2450-2018Class IIProlene Suture 4-36"(90Cm) 4-0 Blue, D5988Ethicon, IncGAW
Z-2449-2018Class IIProlene Suture Blue 4X90cm M1.5 Usp 4/0 Da Rb-1 +P, D5981Ethicon, IncGAW
Z-2448-2018Class IIPROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031Ethicon, IncGAW
Z-2187-2018Class IIAccu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no...Roche Diabetes Care, Inc.LFR
Z-2186-2018Class IIAccu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no...Roche Diabetes Care, Inc.LFR
Z-2185-2018Class IIAccu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos...Roche Diabetes Care, Inc.LFR
Z-2036-2018Class IIAmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No...WRP Asia Pacific Sdn BhdKGO
Z-3280-2018Class IIVITROS Sodium Slides, Catalog # 837 9034Ortho-Clinical Diagnostics, Inc.JGS
Z-2599-2018Class IIMicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining...Siemens Healthcare Diagnostics Inc.LTT
Z-2244-2018Class IIFarabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463Stryker Corp.HXD
Z-2249-2018Class IIDrainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF...Vascular Solutions LLCKGZ
Z-2163-2018Class IIsmith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)Smith & Nephew, Inc.MBH
Z-2137-2018Class IIremel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH...Remel IncJTZ
Z-1916-2018Class IISynthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems...Synthes (USA) Products LLCHXX
Z-2059-2018Class IIRX Imola (RX4900) For Professional Use for the quantitative in vitro determination of...Randox Laboratories, LimitedJJE
Z-3212-2018Class IIMedtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed...Medtronic NeurosurgeryHBO
Z-2034-2018Class IIProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS...Joerns HealthcareIKY
Z-2033-2018Class IIP.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA (b)...Joerns HealthcareIKY
Z-2049-2018Class IIHARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved...Ethicon Endo-Surgery IncLFL
Z-2048-2018Class IIHARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved...Ethicon Endo-Surgery IncLFL
Z-1928-2018Class ICARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX &...Datascope Corp.DSP
Z-2035-2018Class IIHeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product...Philips North America LLCMKJ
Z-3281-2018Class IIAXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm...Stryker Corp.DQY
Z-2539-2018Class IIAD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw...AD-Tech Medical Instrument Corp.HBE
Z-2228-2018Class IIPart #: SAM XT-C, Model: Hi-Viz BlueSam Medical ProductsGAX
Z-2227-2018Class IIPart #: SAM XT-C, Model: Hi-Viz Orange or CivilianSam Medical ProductsGAX
Z-2226-2018Class IIPart #: SAM XT-M, Model: Tactical Black or MilitarySam Medical ProductsGAX
Z-2110-2018Class IINaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number...Fresenius Medical Care Renal Therapies Group, LLCKPO
Z-2565-2018Class IITearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d)...Galt Medical CorpDYB
Z-1903-2018Class IHeartware Medtronic HVAD System for cardiac use. Including the following parts: (a)...HeartWare, Inc.DSQ
Z-1921-2018Class IIsmith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF...Smith & Nephew, Inc.JDI
Z-2564-2018Class IITVS LPA, Catalog #: DIL-059-00Galt Medical CorpKGZ