510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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

59,544 records, page 575 of 1191
FDA device recalls, page 575 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1043-2017Class IIOptilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing...The Binding Site Group Ltd.DEH
Z-2320-2016Class IIRePlant Angled Abutment Part Number 6050-52-60Implant Direct Sybron Manufacturing LLCDZE
Z-2311-2016Class IIIAmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant...Branan Medical Corp.DIO
Z-2601-2016Class IIISiemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version...Siemens Healthcare Diagnostics Inc.KHP
Z-0368-2017Class IIZimmer Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged...Zimmer Surgical SAGFD
Z-2340-2016Class IIZimmer Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is...Zimmer Surgical SAGFD
Z-2339-2016Class IIZimmer Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is...Zimmer Surgical SAGFD
Z-2338-2016Class IIZimmer Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is...Zimmer Surgical SAGFD
Z-2337-2016Class IIZimmer Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged...Zimmer Surgical SAGFD
Z-2336-2016Class IIZimmer Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is...Zimmer Surgical SAGFD
Z-2335-2016Class IIZimmer Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air...Zimmer Surgical SAGFD
Z-2334-2016Class IIZimmer Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome...Zimmer Surgical SAGFD
Z-2832-2016Class IIThe Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A...Circulatory Technology, Inc.DTN
Z-2630-2016Class II120 V Neptune 3 Rover, Model Number: 0703-001-000Stryker Corp.JCX
Z-2396-2016Class IIOrthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument...Howmedica Osteonics CorpJDI
Z-2770-2016Class IIFluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a...Sysmex America, Inc.KQC
Z-2206-2016Class IIRayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and...RaySearch Laboratories AB (publ)MUJ
Z-0057-2017Class IIIThe Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure...Circulatory Technology, Inc.DTN
Z-2290-2016Class IIQuickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of...Sunrise Medical, Inc.IOR
Z-2587-2016Class IIOPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL...Nidek IncorporatedHJO
Z-2296-2016Class IIIntegra External Fixation System Rocker Bottom Model # 12225400. For use in the...Integra LifeSciences CorporationKTT
Z-2326-2016Class IIMentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast...MentorFTR
Z-2343-2016Class II91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration...GE HealthcareDSI
Z-2212-2016Class IDIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s)...Medtronic, Inc.GCJ
Z-2588-2016Class IIPROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use...Microport Orthopedics Inc.LWJ
Z-2792-2016Class IIFemoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first...Howmedica Osteonics CorpHSB
Z-2791-2016Class IISupracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide...Howmedica Osteonics CorpHSB
Z-2668-2016Class IITrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528...Vision Rt IncIYE
Z-2667-2016Class IIAlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use...Vision Rt IncIYE
Z-2292-2016Class IIAvenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer...Zimmer GmbHLZO
Z-2398-2016Class IIZyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.Highridge Medical, LLCMAX
Z-2397-2016Class IIZyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.Highridge Medical, LLCMAX
Z-2345-2016Class IIIMedivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and...C.R. Bard IncDWJ
Z-2847-2016Class IIBroselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches...Medtronic, Inc.CAE
Z-0066-2017Class IITransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to...Champion Mfg, Inc.FPP
Z-0065-2017Class IITransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to...Champion Mfg, Inc.FPP
Z-0064-2017Class IITransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study...Champion Mfg, Inc.FPP
Z-2541-2016Class IITRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization...TYRX Inc.FTL
Z-2540-2016Class IITRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of...TYRX Inc.FTL
Z-2539-2016Class IITRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of...TYRX Inc.FTL
Z-2846-2016Class IIBroselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK...Medtronic, Inc.CAE
Z-2333-2016Class IIISureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK...C.R. Bard IncKNX
Z-2718-2016Class IIArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization...ArjoHuntleigh Polska Sp. zo.o.INQ
Z-0901-2017Class IINIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx...Medtronic Xomed, Inc.ETN
Z-2883-2016Class IITRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go...Trividia Health, Inc.NBW
Z-2882-2016Class IITRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go...Trividia Health, Inc.NBW
Z-2881-2016Class IITRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go...Trividia Health, Inc.NBW
Z-2880-2016Class IITRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go...Trividia Health, Inc.NBW
Z-2389-2016Class IISynthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes...Synthes (USA) Products LLCHRS
Z-2332-2016Class IISpirit Select Bed, A-C Powered Hospital BedCHG Hospital Beds IncFNL