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

59,460 records, page 44 of 1190
FDA device recalls, page 44 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1063-2026Class IIAllura Xper FD10F; Model Number: 722002;Philips Medical Systems Nederland B.V.OWB
Z-1130-2026Class IIBrand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR...Leaseir Technologies SLUGEX
Z-1314-2026Class IIBrevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.Hologic, Inc.KNW
Z-1084-2026Class IIAsserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for...Diagnostica Stago, Inc.LCO
Z-1094-2026Class IIPlum Duo Infusion System, List Number 40002-04-01Abbott MedicalFRN
Z-1120-2026Class IIICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001...Abbott MedicalFRN
Z-1119-2026Class IIICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003...Abbott MedicalFRN
Z-1118-2026Class IIICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)Abbott MedicalFRN
Z-1062-2026Class IIProduct Name: Allura Xper FD10C; Model number: 722001;Philips Medical Systems Nederland B.V.OWB
Z-1164-2026Class IIBrand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta...Elekta LimitedIYE
Z-1200-2026Class IIMedline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1199-2026Class IIMedline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-1198-2026Class IIMedline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-1197-2026Class IIMedline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-1196-2026Class IIMedline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-1195-2026Class IIMedline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-1194-2026Class IIMedline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit...MEDLINE INDUSTRIES, LP - NorthfieldOVN
Z-1193-2026Class IIMedline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1192-2026Class IIMedline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-1191-2026Class IIMedline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1190-2026Class IIMedline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1189-2026Class IIMedline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-1188-2026Class IIMedline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1187-2026Class IIMedline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-1186-2026Class IIMedline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-1367-2026Class IIBroviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff...Bard Peripheral Vascular IncLJS
Z-1340-2026Class IIBrand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning...Elekta LimitedMUJ
Z-1339-2026Class IIBrand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning...Elekta LimitedMUJ
Z-1033-2026Class IIPhilips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.Philips North America LLCMHX
Z-1113-2026Class IIPhilips Azurion system; Software Version Number: R3.1;Philips Medical Systems Nederland B.V.OWB
Z-1091-2026Class IIPhilips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the...Philips Medical Systems Nederland B.V.OWB
Z-1037-2026Class IICodman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP...Integra LifeSciences CorporationGWM
Z-1036-2026Class IICodman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR...Integra LifeSciences CorporationGWM
Z-1093-2026Class IIThinPrep CytoLyt Solution. Buffered Cell Wash Solution.Hologic, Inc.LEA
Z-1185-2026Class IIConductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040...Nipro Technical Solutions, Inc.FKH
Z-2356-2026Class IINexxZr T Multi A3.5 W98-16mm, REF: 745451Sagemax Bioceramics, Inc.EIH
Z-1307-2026Class IIProduct Name: Lumipulse -Amyloid Plasma Controls Model/Catalog Number: 81559 Software...Fujirebio Diagnostics, Inc.SET
Z-1306-2026Class IIProduct Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number...Fujirebio Diagnostics, Inc.SET
Z-1305-2026Class IIProduct Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog...Fujirebio Diagnostics, Inc.SET
Z-1304-2026Class IIProduct Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software...Fujirebio Diagnostics, Inc.SET
Z-1303-2026Class IIProduct Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number...Fujirebio Diagnostics, Inc.SET
Z-1302-2026Class IIProduct Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number...Fujirebio Diagnostics, Inc.SET
Z-1301-2026Class IIProduct Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number...Fujirebio Diagnostics, Inc.SET
Z-1010-2026Class IIKii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23Applied Medical Resources CorpGCJ
Z-1095-2026Class IIThe product is used for the evaluation of the intrinsic coagulation pathway, APTT...Instrumentation Laboratory Co.GFO
Z-2295-2026Class IIPhothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders...The Daavlin Distributing Co.FTC
Z-1024-2026Class IIMAVERICK Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN...Repligen Corporation
Z-1122-2026Class IIMazor X robotic guidance system REF: TPL0059Mazor Robotics LtdOLO
Z-1047-2026Class IIMAXXUS, System, Tomography, Computed, EmissionGE Medical Systems Israel, Functional ImagingKPS
Z-1046-2026Class IISMV BodyTrack, System, Tomography, Computed, EmissionGE Medical Systems Israel, Functional ImagingIYX