Medical Device
Manufacturing
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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 828 of 1190
FDA device recalls, page 828 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3176-2011Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to...Terumo Cardiovascular Systems CorporationKRI
Z-0039-2012Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.Richard-Allan Scientific LLCIDO
Z-1360-2012Removal of Literature/Brochures for Antalgic-Trak. "***What is...Spinetronics, LLCITH
Z-0179-2012Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with...Greiner Bio-One North America, Inc.FMI
Z-3124-2011SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through...STERIS CorporationMLR
Z-3215-2011Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002...Boston Scientific CorporationFCG
Z-3252-2011Cardiovascular Custom Procedure Kits, REV: 0, REV: 2, REV:6 X-Coated FX Perfusion...Terumo Cardiovascular Systems CorporationMJJ
Z-3251-2011Cardiovascular Custom Procedure Kits, REV: 3, REV: 3A, REV:4 FX, CP50 CENT. PK Item...Terumo Cardiovascular Systems CorporationMJJ
Z-3250-2011Cardiovascular Custom Procedure Kits, REV: 4 FX, CP50 CENT. PK Item Number: 73386 Terumo...Terumo Cardiovascular Systems CorporationMJJ
Z-3249-2011Cardiovascular Custom Procedure Kits, REV: 8 Comprensive X-COATED 8000 FX PK Item...Terumo Cardiovascular Systems CorporationMJJ
Z-3248-2011Cardiovascular Custom Procedure Kits, REV: 1A, REV :1 X-COATED FX PK Item Number...Terumo Cardiovascular Systems CorporationMJJ
Z-3247-2011Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number...Terumo Cardiovascular Systems CorporationMJJ
Z-3246-2011Cardiovascular Custom Procedure Kits, REV: 1 REV: 1A COATED FX PK Item Number...Terumo Cardiovascular Systems CorporationMJJ
Z-3245-2011Cardiovascular Custom Procedure Kits, REV: 0, REV: 1 REV: 4, REV: 6A, REV: 6B. REV...Terumo Cardiovascular Systems CorporationMJJ
Z-3244-2011Cardiovascular Custom Procedure Kits, REV: 2, REV:2A, REV: 5, REV: 7 X-Coated FX...Terumo Cardiovascular Systems CorporationMJJ
Z-3243-2011Cardiovascular Custom Procedure Kits, REV : 3 General Low Prime Item Number: 73563 Terumo...Terumo Cardiovascular Systems CorporationMJJ
Z-3242-2011Cardiovascular Custom Procedure Kits, REV : 2, REV: 4 FX, CP50,CENT Pack Item Number...Terumo Cardiovascular Systems CorporationMJJ
Z-3241-2011Cardiovascular Custom Procedure Kits, REV :3. REV: 4, REV: 5, REV: 6, REV:7 X-Coated...Terumo Cardiovascular Systems CorporationMJJ
Z-3240-2011Cardiovascular Custom Procedure Kits, REV :2. REV 2A, REV: 17, REV 18 X-COATED FX...Terumo Cardiovascular Systems CorporationMJJ
Z-3239-2011Cardiovascular Custom Procedure Kits, REV :10. REV 13, REV17, REV 18 FX X-Coated...Terumo Cardiovascular Systems CorporationMJJ
Z-3238-2011Cardiovascular Custom Procedure Kits, REV: 5 STANDARD PACK Item Number: 71701 Terumo...Terumo Cardiovascular Systems CorporationMJJ
Z-3237-2011Cardiovascular Custom Procedure Kits, REV: 5 X-COATED FPS ADULT PACK Item Number...Terumo Cardiovascular Systems CorporationMJJ
Z-3236-2011Cardiovascular Custom Procedure Kits, REV: 1 X-COATED 3/8 X 1/2 A-V LOOP Item Number...Terumo Cardiovascular Systems CorporationMJJ
Z-3235-2011Cardiovascular Custom Procedure Kits, REV: 2 X-COATED 3/8 X 3/8 A-V LOOP Item Number...Terumo Cardiovascular Systems CorporationMJJ
Z-3234-2011Adjustable Valve Item Number: 73631 Terumo Cardiovascular Systems, Ashland, MA...Terumo Cardiovascular Systems CorporationMJJ
Z-3233-2011Cardiovascular Custom Procedure Kits, REV.0 FX 8:1 PACK Item Number: 73329 Terumo...Terumo Cardiovascular Systems CorporationMJJ
Z-3232-2011Cardiovascular Custom Procedure Kits, REV.0, REV 1, REV 1A, REV. 2 XCoated 8:1 FX...Terumo Cardiovascular Systems CorporationMJJ
Z-3231-2011Cardiovascular Custom Procedure Kits, REV.4, REV. 5 X-COATED NEONATAL PACK 3/16" Item...Terumo Cardiovascular Systems CorporationMJJ
Z-3230-2011Cardiovascular Custom Procedure Kits, REV.OB PERFUSION W/8:1 CARDIOPLEGIA Item Number...Terumo Cardiovascular Systems CorporationMJJ
Z-3229-2011Cardiovascular Custom Procedure Kits, REV.3, REV. 5 X-COATED 8:1 CARDIOPLEGIA Item...Terumo Cardiovascular Systems CorporationMJJ
Z-3228-2011Cardiovascular Custom Procedure Kits, REV.2, REV. 3 PUMP & TABLE PACK 1/4 Terumo...Terumo Cardiovascular Systems CorporationMJJ
Z-3227-2011Cardiovascular Custom Procedure Kits, REV..1 X-Coated Stand Alone Adult Pack Item...Terumo Cardiovascular Systems CorporationMJJ
Z-3226-2011Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item...Terumo Cardiovascular Systems CorporationMJJ
Z-3225-2011Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number...Terumo Cardiovascular Systems CorporationMJJ
Z-3224-2011Cardiovascular Custom Procedure Kits, Rev OA FX 8:1 PACK Item Number :73315 Terumo...Terumo Cardiovascular Systems CorporationMJJ
Z-3223-2011Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 X-COATED 8:1 FX...Terumo Cardiovascular Systems CorporationMJJ
Z-3222-2011Cardiovascular Custom Procedure Kits, REV OA PERFUSION W/4:1 CARDIOPLEGIA Item Number...Terumo Cardiovascular Systems CorporationMJJ
Z-3269-2011CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring...Fresenius Medical Care Renal Therapies Group, LLCODX
Z-1041-2012V24-00400-29 cable, an accessory to the Newport HT50 ventilator. The V24-00400-29 cable...Flight Medical Innovations Ltd.CBK
Z-0271-2014Class IISiemens syngo.plaza image processing system image processing radiological systemSiemens Medical Solutions USA, Inc.LLZ
Z-0261-2012Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x...SCC Soft ComputerJQP
Z-0416-2012Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea Container: Foil Pouch with Tyvek...Osteotech IncMBP
Z-0415-2012Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture...Osteotech IncMBP
Z-0628-2012OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff...Innovatech Medical Resources L.P.HWC
Z-0627-20125.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff...Innovatech Medical Resources L.P.MBI
Z-0626-20123.0 60 Degree wand Part Number A2530-01 is an ablation wand Intended for resection...Innovatech Medical Resources L.P.GEI
Z-0625-201290 Degree LoPro with Cable Part Number AC1336-01 is an ablation wand Intended for...Innovatech Medical Resources L.P.GEI
Z-0624-2012Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wandInnovatech Medical Resources L.P.GEI
Z-0623-2012Turbo Vac 90 with Cable Part Number ASC1335-01 is an ablation wand Indicated for...Innovatech Medical Resources L.P.GEI
Z-0622-2012Saber 30 Part Number A4330-01 is an ablation wand Indicated for resection, ablation, and...Innovatech Medical Resources L.P.GEI