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 179 of 1190
FDA device recalls, page 179 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0301-2024Class IILIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020Physio Control, Inc.MKJ
Z-0300-2024Class IILIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002Physio Control, Inc.MKJ
Z-0299-2024Class IILIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602Physio Control, Inc.MKJ
Z-0298-2024Class IILIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067Physio Control, Inc.MKJ
Z-0297-2024Class IILIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061Physio Control, Inc.MKJ
Z-0474-2024Class IIEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.Staar Surgical AGMTA
Z-0473-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.Staar Surgical AGQCB
Z-0472-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.Staar Surgical AGQCB
Z-0471-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.Staar Surgical AGQCB
Z-0470-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.Staar Surgical AGQCB
Z-0469-2024Class IIEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.Staar Surgical AGMTA
Z-0359-2024Class IIGEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part...Instrumentation Laboratory Co.CHL
Z-0358-2024Class IIGEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507...Instrumentation Laboratory Co.CHL
Z-0357-2024Class IIGEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004...Instrumentation Laboratory Co.CHL
Z-0468-2024Class IIEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.Staar Surgical AGMTA
Z-0467-2024Class IIEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.Staar Surgical AGMTA
Z-0466-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.Staar Surgical AGMTA
Z-0465-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.Staar Surgical AGMTA
Z-0464-2024Class IIEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.Staar Surgical AGMTA
Z-0326-2024Class IIAlinity c Iron Reagent, Reference Number 08P3920Sentinel CH SpAJIY
Z-0325-2024Class IIIRON assay, Reference Numbers 6K95-41 and 6K95-30Sentinel CH SpAJIY
Z-0296-2024Class IILIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051Physio Control, Inc.MKJ
Z-0258-2024Class IIDJO EMPOWR Knee Punch Handle, REF: 801-05-040Encore Medical, LPMBH
Z-0557-2024Class IITRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GPOLYMPUS Corporation of the AmericasEOQ
Z-0209-2024Class IIAbbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generatorAbbott MedicalGXD
Z-0144-2024Class IStolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000Medtronic, Inc.CCW
Z-0397-2024Class IIEXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN #...Boston Scientific CorporationFDT
Z-0396-2024Class IIEXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN#...Boston Scientific CorporationFDT
Z-0188-2024Class IStealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation...Medtronic Navigation, IncHAW
Z-0158-2024Class IIJOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee...Smith & Nephew, Inc.JWH
Z-0157-2024Class IIJOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesisSmith & Nephew, Inc.JWH
Z-0404-2024Class IISENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number...PathEWO
Z-0403-2024Class IIAuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part...PathEWO
Z-0402-2024Class IISENTIERO Screening2, mobile medical devices for hearing examinations, Model Number...PathEWO
Z-0401-2024Class IISENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part...PathEWO
Z-0423-2024Class IIRAPIDPOINT 500 Blood Gas SystemSiemens Healthcare Diagnostics Inc.JGS
Z-0422-2024Class IIRAPIDPOINT 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.JGS
Z-0286-2024Class ICordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac...Cordis US Corp.DQO
Z-0167-2024Class IIGrafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e)...Medtronic Sofamor Danek USA IncMBP
Z-0166-2024Class IIGrafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized...Medtronic Sofamor Danek USA IncMBP
Z-0165-2024Class IIGrafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150...Medtronic Sofamor Danek USA IncMBP
Z-0164-2024Class IIGrafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone MatrixMedtronic Sofamor Danek USA IncMBP
Z-0163-2024Class IIGrafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone MatrixMedtronic Sofamor Danek USA IncMBP
Z-0162-2024Class IIGrafton DBM (Flex), Model Numbers: T42100, Demineralized Bone MatrixMedtronic Sofamor Danek USA IncMBP
Z-0161-2024Class IIGrafton DBM Crunch, Model Numbers: T44115, Demineralized Bone MatrixMedtronic Sofamor Danek USA IncMBP
Z-0136-2024Class IIBULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.B Braun Medical IncFPA
Z-0135-2024Class II30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management...B Braun Medical IncDXT
Z-0134-2024Class IIALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.B Braun Medical IncLCJ
Z-0133-2024Class IITHERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use...B Braun Medical IncONB
Z-0132-2024Class IITERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV...B Braun Medical IncFPA