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 24 of 1187
FDA device recalls, page 24 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2000-2026Class IIi-STAT EG6+ cartridge; List Number: 03P77-25;Abbott MedicalCHL
Z-1999-2026Class IIi-STAT EG7+ cartridge; List Number: 03P76-25;Abbott MedicalCHL
Z-2170-2026Class IIPhilips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229)...Philips Medical Systems Nederland B.V.OWB
Z-2064-2026Class IIERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222Erbe Medical, LLCOCX
Z-2063-2026Class IIERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap...Erbe Medical, LLCOCX
Z-2062-2026Class IIERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF...Erbe Medical, LLCFEQ
Z-2049-2026Class IILUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON...Boston Scientific CorporationMXD
Z-2048-2026Class IILUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US...Boston Scientific CorporationMXD
Z-1946-2026Class IIBrand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and...Zimmer GmbHJDZ
Z-1995-2026Class IIStraumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental...Straumann USA, LLCNHA
Z-1947-2026Class IAIDBAGs are first aid kits of convenience composed of individually labeled devices...North American Rescue LLC.LRR
Z-1994-2026Class IIStraumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article...Straumann USA, LLCNHA
Z-1918-2026Class IIRover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71Micro-X Ltd.IZL
Z-2172-2026Class IIEdwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EOEdwards Lifesciences LLCNPW
Z-2155-2026Class IIRevolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27GE HealthcareJAK
Z-2154-2026Class IIRevolution Apex, X-ray Computed Tomography, Model Number 5590000-20GE HealthcareJAK
Z-2153-2026Class IIRevolution CT ES, X-ray Computed Tomography, Model Number 5590000-15GE HealthcareJAK
Z-2152-2026Class IIRevolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25GE HealthcareJAK
Z-2151-2026Class IIRevolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23GE HealthcareJAK
Z-2150-2026Class IIRevolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6GE HealthcareJAK
Z-2149-2026Class IIRevolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300GE HealthcareJAK
Z-2052-2026Class IIBrand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command...GE HealthcareDSI
Z-1984-2026Class IIImmy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For...IMMY, Inc.PPM
Z-2132-2026Class IIZenbone, Ref: Orb-0320C-Z, Orb-0310C-Z, Orb-0304C-ZOrthorebirth Co LtdMQV
Z-2131-2026Class IIBioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC...Orthorebirth Co LtdMQV
Z-2080-2026Class IIDEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number...Katalyst Surgical, LLCHNR
Z-2047-2026Class IRolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028...Omnicell, Inc.NEP
Z-2079-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number...Katalyst Surgical, LLCHNR
Z-2078-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number...Katalyst Surgical, LLCHNR
Z-2077-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number...Katalyst Surgical, LLCHNR
Z-2076-2026Class IIDEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number...Katalyst Surgical, LLCHNR
Z-2075-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number...Katalyst Surgical, LLCHNR
Z-2074-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number...Katalyst Surgical, LLCHNR
Z-2073-2026Class IIDEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number...Katalyst Surgical, LLCHNR
Z-2072-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number...Katalyst Surgical, LLCHNR
Z-2071-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog...Katalyst Surgical, LLCHNR
Z-2070-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number...Katalyst Surgical, LLCHNR
Z-2069-2026Class IIDEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number...Katalyst Surgical, LLCHNR
Z-1923-2026Class IIOxoid Agglutinating Sera, Salmonella 9-0 R30957301Remel Europe Ltd.GRM
Z-1998-2026Class IIIHeraeus, PALAMIX duo. Material Number: 66057897.Heraeus Medical GmbHJDZ
Z-1997-2026Class IIIHeraeus, PALAMIX uno. Material Number: 66057893.Heraeus Medical GmbHJDZ
Z-1896-2026Class IIAvitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number...Davol Inc., Sub. C.R. Bard, Inc.LMF
Z-1942-2026Class IVOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000Ventec Life Systems, Inc.NOU
Z-1909-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.OLYMPUS Corporation of the AmericasFEB
Z-1908-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.OLYMPUS Corporation of the AmericasFEB
Z-1907-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.OLYMPUS Corporation of the AmericasFEB
Z-1906-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.OLYMPUS Corporation of the AmericasFEB
Z-1905-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.OLYMPUS Corporation of the AmericasFEB
Z-1904-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.OLYMPUS Corporation of the AmericasFEB
Z-1903-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.OLYMPUS Corporation of the AmericasFEB