510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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

59,528 records, page 691 of 1191
FDA device recalls, page 691 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2552-2014Class IIKnee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT...Zimmer GmbHJWH
Z-2551-2014Class IIMoore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP...Zimmer GmbHJDG
Z-2550-2014Class IITrauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT...Zimmer GmbHHRS
Z-2549-2014Class IITrauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE...Zimmer GmbHHWC
Z-2548-2014Class IIEndo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA...Zimmer GmbHJDI
Z-2547-2014Class IIEndo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO...Zimmer GmbHJDI
Z-2251-2014Class II4.0 mm Cancellous Screw, Partially Threaded Sterile ZimmerZimmer GmbHHWC
Z-2250-2014Class II4.5 mm Malleolar Screw Sterile zimmerZimmer GmbHHWC
Z-2249-2014Class II6.5 mm Cancellous Screw Fully Threaded Sterile zimmerZimmer GmbHHWC
Z-2248-2014Class II6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmerZimmer GmbHHWC
Z-2247-2014Class II6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmerZimmer GmbHHWC
Z-2246-2014Class II6.5 mm Cancellous Screw Fully Threaded Sterile zimmerZimmer GmbHHWC
Z-2245-2014Class IIMagna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmerZimmer GmbHHWC
Z-2244-2014Class IIMagna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmerZimmer GmbHHWC
Z-2546-2014Class IIKnee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW...Zimmer GmbHLXH
Z-2656-2014Class IIZenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741...GF Health Products, Inc.FNL
Z-2179-2014Class IIMedtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The...Medtronic, Inc.MDS
Z-0041-2015Class IIRENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product...Smith & Nephew, Inc.OMP
Z-0040-2015Class IIRENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ...Smith & Nephew, Inc.OMP
Z-0039-2015Class IIRENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ...Smith & Nephew, Inc.OMP
Z-2650-2014Class IIIStago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended...Diagnostica Stago, Inc.KFF
Z-2207-2014Class IIX-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541Gambro Renal ProductsFLD
Z-2206-2014Class IIPrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment...Gambro Renal ProductsFLD
Z-2165-2014Class IITranspac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing...Abbott MedicalDRS
Z-2164-2014Class IISingle Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe...Abbott MedicalDRS
Z-2163-2014Class IITranspac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No...Abbott MedicalDRS
Z-2162-2014Class IIArterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP...Abbott MedicalDRS
Z-2161-2014Class IISingle Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item...Abbott MedicalDRS
Z-2160-2014Class IITrifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6...Abbott MedicalDRS
Z-2159-2014Class IIArterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap...Abbott MedicalDRS
Z-2158-2014Class IITrifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and...Abbott MedicalDRS
Z-2157-2014Class IITranspac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2...Abbott MedicalDRS
Z-2233-2014Class IIIBD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process...Becton, Dickinson and Company, BD BiosciencesGKZ
Z-2205-2014Class IIPrismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4...Gambro Renal ProductsKDI
Z-2204-2014Class IIPrismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4...Gambro Renal ProductsKDI
Z-2203-2014Class IIPrismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4...Gambro Renal ProductsKDI
Z-2202-2014Class IIPrismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4...Gambro Renal ProductsKDI
Z-2201-2014Class IIPrismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4...Gambro Renal ProductsKDI
Z-2200-2014Class IIPrisma HF1000 preset (new design). Product number 107639. Each set is packaged in a...Gambro Renal ProductsKDI
Z-2199-2014Class IIPrisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a...Gambro Renal ProductsKDI
Z-2198-2014Class IIPrisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4...Gambro Renal ProductsKDI
Z-2197-2014Class IIPrisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4...Gambro Renal ProductsKDI
Z-2196-2014Class IIPrisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic...Gambro Renal ProductsKDI
Z-2195-2014Class IIPrisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a...Gambro Renal ProductsKDI
Z-2194-2014Class IIPrisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4...Gambro Renal ProductsMDP
Z-2193-2014Class IIPrismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch...Gambro Renal ProductsMDP
Z-2239-2014Class IITomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software...Accuray IncorporatedIYE
Z-2243-2014Class ICloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film...Cook IncorporatedMMX
Z-2669-2014Class IIPedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended...Genesisbps LLCBRZ
Z-2668-2014Class IIPedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS...Genesisbps LLCBRZ