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 58 of 1190
FDA device recalls, page 58 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0527-2026Class IIMEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-0526-2026Class IIMEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-0525-2026Class IIMEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826OMEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-0524-2026Class IIMEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-0523-2026Class IIMEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-0522-2026Class IIMEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-0521-2026Class IIMEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2)...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0520-2026Class IIMEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2)...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-0519-2026Class IIMEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2)...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-0518-2026Class IIMEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597MEDLINE INDUSTRIES, LP - NorthfieldOHR
Z-0517-2026Class IIMEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-0516-2026Class IIMEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-0515-2026Class IIMEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-0514-2026Class IIMEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-0513-2026Class IIMEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0512-2026Class IIMEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818AMEDLINE INDUSTRIES, LP - NorthfieldOES
Z-0511-2026Class IIMEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418MMEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-0164-2026Class IIMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI...IMRIS Imaging, Inc.LNH
Z-0163-2026Class IIMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDAIMRIS Imaging, Inc.LNH
Z-0162-2026Class IIMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, SkyraIMRIS Imaging, Inc.LNH
Z-0161-2026Class IIMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3...IMRIS Imaging, Inc.LNH
Z-0326-2026Class IIAlcon PRECISION1 One-Day Contact Lenses, -2.25D.Alcon LaboratoriesLPL
Z-0417-2026Class IIBrand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i"...Prismatik Dentalcraft, Inc.NHA
Z-0433-2026Class IIBrand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic...Elekta LimitedHAW
Z-0070-2026Class IBrand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR...B Braun Medical IncFJK
Z-0371-2026Class IIAll Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00CareFusion 303, IncBRY
Z-0370-2026Class IIBD Pyxis Pro MedStation Main, REF: 1155-00CareFusion 303, IncBRY
Z-0369-2026Class IIVarious models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00CareFusion 303, IncBRY
Z-0368-2026Class IIVarious models of BD Pyxis MedFlex, Reference numbers...CareFusion 303, IncBRY
Z-0367-2026Class IIVarious models of BD Pyxis Medbank: Reference numbers...CareFusion 303, IncBRY
Z-0241-2026Class IIZenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray systemPhilips Medical Systems Nederland B.V.OWB
Z-0949-2026Class IIBrand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103...Dsaart, LLCMIB
Z-0567-2026Class IISAFE-T-FILL Micro Collection Tube Extender, Model 09 1004ASP Global, LLCGIO
Z-0566-2026Class IIMixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503ASP Global, LLCGIO
Z-0565-2026Class IISAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502ASP Global, LLCGIO
Z-0564-2026Class IISAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6...ASP Global, LLCGIO
Z-0457-2026Class IIBATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No...GE Healthcare Finland OyMHX
Z-0456-2026Class IIPortrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia...GE Healthcare Finland OyMHX
Z-0455-2026Class IIB105P, B125P, B105M, B125M, B155M Patient Monitors; Model...GE Healthcare Finland OyMHX
Z-0454-2026Class IICARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or...GE Healthcare Finland OyMHX
Z-0453-2026Class IICarescape B450, Model no. 5805686 - shipped with potentially affected batteries or...GE Healthcare Finland OyMHX
Z-0419-2026Class IIZimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm...Zimmer GmbHLPH
Z-0418-2026Class IIZimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm...Zimmer GmbHLPH
Z-0948-2026Class IIBrand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog...Dsaart, LLCMIC
Z-0947-2026Class IIBrand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog...Dsaart, LLCLZK
Z-0946-2026Class IIBrand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101...Dsaart, LLCFWP
Z-0945-2026Class IIBrand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog...Dsaart, LLCMIB
Z-0410-2026Class IIBrand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog...Medistim ASADPW
Z-0944-2026Class IIBrand Name: AART Silicone Carving Implant Product Name: Silicone Carving...Dsaart, LLCMIB
Z-0229-2026Class IILOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS...Synthes (USA) Products LLCJDS