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 155 of 1190
FDA device recalls, page 155 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2036-2024Class IIINEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a...Halyard HealthKYX
Z-2035-2024Class IIINEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a...Halyard HealthKYX
Z-1603-2024Class IIIBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12...Ion Beam Applications S.A.LHN
Z-1508-2024Class IIEZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic...QiagenJJH
Z-1480-2024Class IIAlinity i Anti-HCV Reagent Kit, List Number 08P0521Abbott MedicalMZO
Z-1479-2024Class IIARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35Abbott MedicalMZO
Z-1393-2024Class IIX-Guide Handpiece Adaptor Sleeve 3, Model P010727X-NAV Technologies, LLCQRY
Z-1392-2024Class IIX-Guide Handpiece Adaptor Sleeve 1, Model P010701X-NAV Technologies, LLCQRY
Z-2977-2024Class IIN-LHP-928, HeNe Laser System, 35 mWPacific Lasertech, LLCRDW
Z-2976-2024Class II25-LHP-928, HeNe Laser System, 25 mWPacific Lasertech, LLCRDW
Z-2975-2024Class II25-LHP-828, HeNe Laser System, 35 mWPacific Lasertech, LLCRDW
Z-2142-2024Class IIVITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator...Ortho-Clinical Diagnostics, Inc.LOM
Z-1918-2024Class IIMedline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1917-2024Class IICenturion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience trayMEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-1693-2024Class IThoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnlyAbbott MedicalDSQ
Z-1692-2024Class IThoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnlyAbbott MedicalDSQ
Z-1532-2024Class IIDilator - Coons Taper - Used for dilating puncture sites or catheter tracts for...Cook IncorporatedFGE
Z-1531-2024Class IIDilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or...Cook IncorporatedFGE
Z-1530-2024Class IIDilator - Intended to be used for dilating puncture sites or catheter tracts for...Cook IncorporatedFGE
Z-1529-2024Class IIEntuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the...Cook IncorporatedFGE
Z-1528-2024Class IIPeel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode...Cook IncorporatedDYB
Z-1527-2024Class IIYueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid...Cook IncorporatedGCB
Z-1526-2024Class IITrocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous...Cook IncorporatedDRC
Z-1525-2024Class IIChiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER...Cook IncorporatedMJG
Z-1702-2024Class IIAbbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170Alere San Diego, Inc.CGA
Z-1328-2024Class IILiquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with...Randox Laboratories, LimitedJIX
Z-1548-2024Class IIOlympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and...OLYMPUS Corporation of the AmericasKNS
Z-1547-2024Class IIOlympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and...OLYMPUS Corporation of the AmericasKNS
Z-1357-2024Class IPhantom 2 Nasal Vented MaskSleepNet CorporationBZD
Z-1356-2024Class IiQ 2 Nasal Vented MaskSleepNet CorporationBZD
Z-1355-2024Class IMojo 2 Full Face AAV Non Vented Mask, All SizesSleepNet CorporationBZD
Z-1354-2024Class IMojo 2 Full Face Non Vented Mask, All SizesSleepNet CorporationBZD
Z-1353-2024Class IMojo 2 Full Face Vented Mask, All SizesSleepNet CorporationBZD
Z-1352-2024Class IMojo Non Vented Full Face Mask with Headgear, All SizesSleepNet CorporationBZD
Z-1351-2024Class IMojo Full Face with Headgear, All SizesSleepNet CorporationBZD
Z-2795-2026Class IIPermobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3Permobil, ABITI
Z-2237-2024Class IIBeckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry...Siemens Healthcare Diagnostics Inc.JJE
Z-1399-2024Class IIBD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated...Becton Dickinson & CoLON
Z-1398-2024Class IIBD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated...Becton Dickinson & CoLON
Z-1620-2024Class IIMariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha...SeaSpine Orthopedics CorporationNKB
Z-1387-2024Class IICareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade)...Philips North America LLCMSX
Z-1386-2024Class IIPatient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and...Philips North America LLCMHX
Z-1380-2024Class IIBaxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c)...Baxter Healthcare CorporationFTM
Z-1379-2024Class IIBaxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814...Baxter Healthcare CorporationFTM
Z-1378-2024Class IIBaxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b)...Baxter Healthcare CorporationFTM
Z-1377-2024Class IIBaxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b)...Baxter Healthcare CorporationFTM
Z-1471-2024Class IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNLMedtronic, Inc.GCJ
Z-1470-2024Class IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTMedtronic, Inc.GCJ
Z-1469-2024Class IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSMedtronic, Inc.GCJ
Z-1468-2024Class IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTMedtronic, Inc.GCJ