510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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

59,336 records, page 19 of 1187
FDA device recalls, page 19 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2311-2026Class IIPlum Solo Precision IV Pump, 40001-0401Abbott MedicalFRN
Z-2614-2026Class IISYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code...MentorFMF
Z-2225-2026Class IIPhilips Azurion systems not configured with an optional auxiliary pan handle. Includes...Philips Medical Systems Nederland B.V.OWB
Z-2229-2026Class IIIntegris-Allura system; System Code Description (Model Numbers): Integris CV...Philips Medical Systems Nederland B.V.OWB
Z-2228-2026Class IIAllura system; System Code Description (Model Numbers): Allura Xper FD10C (722001)...Philips Medical Systems Nederland B.V.OWB
Z-2227-2026Class IIAzurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion...Philips Medical Systems Nederland B.V.OWB
Z-2447-2026Class IIMedline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485LMEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-2446-2026Class IIMedline convenience kits: C SECTION CDS985505G C SECTION...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-2445-2026Class IIMedline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-2444-2026Class IIMedline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2443-2026Class IIMedline convenience kits: PORT A CATH DYNJ906818AMEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2442-2026Class IIMedline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739BMEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-2441-2026Class IIMedline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2440-2026Class IIMedline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2439-2026Class IIMedline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2438-2026Class IIMedline convenience kits: CMH CENTRAL LINE DRESSING CHANGE...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-2437-2026Class IICenturion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B DIALYSIS CATHETER...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-2436-2026Class IIMedline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2435-2026Class IIMedline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053KMEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-2434-2026Class IIMedline convenience kits: DAVINCI MAIN DYNJ908031DMEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-2433-2026Class IIMedline convenience kits: WT LAVH PACK DYNJ46609FMEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-2432-2026Class IIMedline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533CMEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-2431-2026Class IIMedline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-2430-2026Class IIMedline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619MMEDLINE INDUSTRIES, LP - NorthfieldMLT
Z-2429-2026Class IIMedline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895FMEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-2428-2026Class IIMedline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2427-2026Class IIMedline convenience kit: HERNIA REPAIR TOTE DYNJ908337DMEDLINE INDUSTRIES, LP - NorthfieldPAD
Z-2426-2026Class IIMedline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-2425-2026Class IIMedline convenience kit: IV START KIT W/HUBGUARD DYNDV2662MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-2424-2026Class IIMedline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2423-2026Class IIMedline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-2422-2026Class IIMedline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-2421-2026Class IIMedline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ9017...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-2420-2026Class IIMedline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853LMEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-2419-2026Class IIMedline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-2418-2026Class IIMedline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ5629...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2417-2026Class IIMinor Cath Lab Pack Dynj84775a or Vascular Angio Pack Dynj47269d Port-a-Cath Dynj63276gMEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2416-2026Class IIBlock Tray Dynjra2119a Indwelling Nerve Block Dynjra1011aMEDLINE INDUSTRIES, LP - NorthfieldOGI
Z-2415-2026Class IIMedline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-2414-2026Class IIMedline EBSI Kit EBSI1534MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-2275-2026Class IIPhaseOne Antimicrobial Solution, Model/Catalog Number: 15050Oculus Technologies of Mexico, S.A de C.V.FRO
Z-2307-2026Class IIAligned Medical AMS16835 Fluids Kit RXWindstone Medical Packaging, Inc.LRO
Z-2257-2026Class IBDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL...Becton Dickinson & CoCAZ
Z-2256-2026Class IBDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL...Becton Dickinson & CoCAZ
Z-2255-2026Class IBDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL...Becton Dickinson & CoCAZ
Z-2254-2026Class IBDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL...Becton Dickinson & CoCAZ
Z-2253-2026Class IBDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in., BDQuincke Needle 22 G x 3.5 in...Becton Dickinson & CoCAZ
Z-2252-2026Class IBDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL...Becton Dickinson & CoCAZ
Z-2251-2026Class IBDSpinal Tray with BDWhitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL...Becton Dickinson & CoCAZ
Z-2250-2026Class IBDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine...Becton Dickinson & CoCAZ