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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

59,486 records, page 334 of 1190
FDA device recalls, page 334 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2746-2020Class IISUTUREFIX ULTRA Suture, Product number 72203855Smith & Nephew, Inc.MBI
Z-2685-2020Class IITRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw...Smith & Nephew, Inc.JDS
Z-2744-2020Class IISutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical...Sutter Medizintechnik GmbHGEI
Z-2686-2020Class IIMEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation...Mevion Medical Systems, Inc.LHO
Z-2884-2020Class IINeurosign V4 Intraoperative Nerve monitor family of devices.Magstim Inc.PDQ
Z-2714-2020Class IITTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lensesChengdu Ai Qin E-commerce Co., LtdLPL
Z-2713-2020Class IITTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lensesChengdu Ai Qin E-commerce Co., LtdLPL
Z-2712-2020Class IITTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lensesChengdu Ai Qin E-commerce Co., LtdLPL
Z-2711-2020Class IITTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lensesChengdu Ai Qin E-commerce Co., LtdLPL
Z-2710-2020Class IITTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lensesChengdu Ai Qin E-commerce Co., LtdLPL
Z-2709-2020Class IITTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lensesChengdu Ai Qin E-commerce Co., LtdLPL
Z-2708-2020Class IITTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lensesChengdu Ai Qin E-commerce Co., LtdLPL
Z-3025-2020Class IISoftware versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force...Siemens Medical Solutions USA, Inc.JAK
Z-2750-2020Class IICARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter...GE HealthcareMHX
Z-2880-2020Class IICARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe...Biosense Webster (Israel), Ltd.DQK
Z-2705-2020Class IIComputed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036...Shanghai United Imaging Healthcare Co., Ltd.JAK
Z-2704-2020Class IIComputed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012...Shanghai United Imaging Healthcare Co., Ltd.JAK
Z-2703-2020Class IIComputed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043...Shanghai United Imaging Healthcare Co., Ltd.JAK
Z-2806-2020Class IIClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO...Argon Medical Devices, IncDRE
Z-0480-2021Class IIEMPOWR Partial Knee Peg Drill; Model: 800-06-008.Encore Medical, LPHSX
Z-0479-2021Class IIEMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.Encore Medical, LPHSX
Z-2701-2020Class IIAlinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software...Abbott MedicalJJE
Z-2671-2020Class IISafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI...Becton Dickinson & CoPTI
Z-2670-2020Class IIPowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329)...Becton Dickinson & CoPTI
Z-2669-2020Class IISafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap...Becton Dickinson & CoPTI
Z-2668-2020Class IISafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access...Becton Dickinson & CoPTI
Z-2667-2020Class IISafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number...Becton Dickinson & CoPTI
Z-2666-2020Class IISafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482)...Becton Dickinson & CoPTI
Z-2665-2020Class IISafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI...Becton Dickinson & CoPTI
Z-2664-2020Class IISafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI...Becton Dickinson & CoPTI
Z-2663-2020Class IIPowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic...Becton Dickinson & CoPTI
Z-2662-2020Class IIPowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI...Becton Dickinson & CoPTI
Z-2661-2020Class IIPowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers...Becton Dickinson & CoPTI
Z-2660-2020Class IIPowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers...Becton Dickinson & CoPTI
Z-2809-2020Class IIChembio DPP Micro Reader II for use with the DPP COVID-19 IgM/IgG System- Rapid...Chembio Diagnostic Systems, Inc.QKO
Z-2808-2020Class IIChembio DPP Micro Reader for use with the DPP COVID-19 IgM/IgG System- Rapid...Chembio Diagnostic Systems, Inc.QKO
Z-2807-2020Class IIChembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the...Chembio Diagnostic Systems, Inc.QKO
Z-2812-2020Class IIPhillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is...Philips North America LLCMWI
Z-2811-2020Class IIPhillips Charging Station, Product #: 989803191021 - Product Usage: This charging station...Philips North America LLCMWI
Z-2810-2020Class IIPhillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage...Philips North America LLCMWI
Z-2780-2020Class IIHolder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators...Maquet Cardiovascular Us Sales, LLCKRI
Z-2778-2020Class IIAnjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048...G-5 Florida LLCJEC
Z-2698-2020Class IIMatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of...Synthes GmbHJEY
Z-2475-2020Class IIMueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per boxMueller Sports Medicine, IncITQ
Z-2699-2020Class IIregard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG...Resource Optimization & Innovation, LLCJOJ
Z-2645-2020Class IILoFric Origo, Tiemann, 16in, FR14 urinary cathetersWellspect HealthcareEZD
Z-2644-2020Class IILoFric Origo, Tiemann, 16in, FR12 urinary cathetersWellspect HealthcareEZD
Z-2643-2020Class IILoFric Origo, Nelaton, 16in, FR10 urinary cathetersWellspect HealthcareEZD
Z-2540-2020Class IIFHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and...FHC, Inc.GZL
Z-2983-2020Class IIDxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a...Beckman Coulter Biomedical GmbHJJE