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 157 of 1190
FDA device recalls, page 157 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1442-2024Class IICenturion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246)...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-1441-2024Class IICenturion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256)...MEDLINE INDUSTRIES, LP - NorthfieldKDC
Z-1440-2024Class IICenturion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code...MEDLINE INDUSTRIES, LP - NorthfieldHXD
Z-1439-2024Class IICenturion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product...MEDLINE INDUSTRIES, LP - NorthfieldHTF
Z-1438-2024Class IICenturion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340...MEDLINE INDUSTRIES, LP - NorthfieldHRQ
Z-1437-2024Class IICenturion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code...MEDLINE INDUSTRIES, LP - NorthfieldGEN
Z-1462-2024Class IIAgfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality...Agfa N.V.IZL
Z-1436-2024Class IICenturion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code...MEDLINE INDUSTRIES, LP - NorthfieldGDZ
Z-1435-2024Class IICenturion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660...MEDLINE INDUSTRIES, LP - NorthfieldGDG
Z-1434-2024Class IICenturion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product...MEDLINE INDUSTRIES, LP - NorthfieldGAD
Z-1486-2024Class IIAltair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger...Human Care HC ABFSA
Z-1433-2024Class IICenturion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505MEDLINE INDUSTRIES, LP - NorthfieldEPY
Z-1432-2024Class IICenturion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830MEDLINE INDUSTRIES, LP - NorthfieldKAI
Z-1431-2024Class IICenturion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL...MEDLINE INDUSTRIES, LP - NorthfieldOFX
Z-1430-2024Class IICenturion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430STMEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-1429-2024Class IICenturion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6MEDLINE INDUSTRIES, LP - NorthfieldOFX
Z-1428-2024Class IICenturion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575MEDLINE INDUSTRIES, LP - NorthfieldBWB
Z-1427-2024Class IICenturion STERILE TRACH BRUSH, Product Code 6225STMEDLINE INDUSTRIES, LP - NorthfieldEPE
Z-1524-2024Class IISurgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers...Baxter Healthcare CorporationDXC
Z-1523-2024Class IISurgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers...Baxter Healthcare CorporationDXC
Z-1522-2024Class IISurgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers...Baxter Healthcare CorporationDXC
Z-1383-2024Class IIRELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system...Bolton Medical Inc.MIH
Z-1476-2024Class IIARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.Abbott MedicalDDR
Z-1330-2024Class IISituate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1Medtronic, Inc.GDY
Z-1286-2024Class INimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II...InfuTronix LLCFRN
Z-1285-2024Class INimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory...InfuTronix LLCFRN
Z-1367-2024Class IIMediBeads King Pad, Item Numbers: 34120, 34120PM, 34125RBruder Healthcare CompanyIMA
Z-1366-2024Class IIMediBeads Neck Wrap, Item Number 34320Bruder Healthcare CompanyIMA
Z-1365-2024Class IIThermalon Stye Compress, Item Number 24352Bruder Healthcare CompanyIMA
Z-1364-2024Class IIThermalon Heating Pad, Item Number 24002Bruder Healthcare CompanyIMA
Z-1363-2024Class IIThermalon Neck Wrap, Item Number 24322Bruder Healthcare CompanyIMA
Z-1362-2024Class IIThermalon Back Wrap, Item Number 24312Bruder Healthcare CompanyIMA
Z-1361-2024Class IIThermalon Sinus Compress, Item Number 24332Bruder Healthcare CompanyIMA
Z-1360-2024Class IIThermalon Sinus Compress (French), Item Number 24332FBruder Healthcare CompanyIMA
Z-1359-2024Class IIThermalon Eye Compress, Item Number 2434Bruder Healthcare CompanyIMA
Z-1370-2024Class IISYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical...Alcon LaboratoriesLRO
Z-1391-2024Class IIHydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.Puritan Medical Products Company, LLCKXG
Z-1461-2024Class IIIHALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)O&M Halyard, Inc.FXY
Z-1517-2024Class IIEndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition...Boston Scientific CorporationKNT
Z-1516-2024Class IIEndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into...Boston Scientific CorporationKNT
Z-1515-2024Class IIEndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into...Boston Scientific CorporationKNT
Z-1514-2024Class IIEndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition...Boston Scientific CorporationPIF
Z-1513-2024Class IIEndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition...Boston Scientific CorporationPIF
Z-1374-2024Class IObsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010Boston Scientific CorporationKRD
Z-1401-2024Class IICardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part...Terumo Cardiovascular Systems CorporationOEZ
Z-1390-2024Class IIBoston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral...Boston Scientific CorporationDYB
Z-1475-2024Class II3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube...3M CompanyKGX
Z-1350-2024Class IIConvatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b)...ConvaTec LimitedFON
Z-1301-2024Class IHeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft...Abbott MedicalDSQ
Z-1300-2024Class IHeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft...Abbott MedicalDSQ