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 182 of 1190
FDA device recalls, page 182 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0248-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number...Stryker Corp.GEI
Z-0247-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number...Stryker Corp.GEI
Z-0246-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number...Stryker Corp.GEI
Z-0245-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number...Stryker Corp.GEI
Z-0244-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number...Stryker Corp.GEI
Z-0243-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number...Stryker Corp.GEI
Z-0242-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number...Stryker Corp.GEI
Z-0241-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number...Stryker Corp.GEI
Z-0240-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number...Stryker Corp.GEI
Z-0239-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number...Stryker Corp.GEI
Z-0094-2024Class ISapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF...Eitan Medical LtdFRN
Z-0070-2024Class IIGS0008 2Y - Burn Pack - STL, Item Number 880082025ROi CPS LLCOJJ
Z-0160-2024Class IIOmega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085Omega Medical Imaging, LLCIWE
Z-2656-2023Class IIF2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)GE Medical Systems China Co., Ltd.MHX
Z-0143-2024Class IIUniversal Viewer Workflow Manager, Image processing radiological systemGE HealthcareLLZ
Z-0142-2024Class IICentricity Universal Viewer Workflow Manager, Image processing radiological systemGE HealthcareLLZ
Z-0238-2024Class IIFogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35Edwards Lifesciences LLCDXE
Z-0260-2024Class IIAlcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N...Alcon LaboratoriesLRO
Z-0041-2024Class IIReal Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0...Blue Belt Technologies, Inc.OLO
Z-0532-2024Class IIRSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.Encore Medical, LPPHX
Z-0309-2024Class IIAU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter...Beckman Coulter Ireland IncDDD
Z-0202-2024Class IIRX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000Randox Laboratories, LimitedCGA
Z-0201-2024Class IIRX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000Randox Laboratories, LimitedCGA
Z-0200-2024Class IIRX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)Randox Laboratories, LimitedCEM
Z-0199-2024Class IIRX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R...Randox Laboratories, LimitedCIT
Z-0198-2024Class IIRX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040Randox Laboratories, LimitedCGA
Z-0141-2024Class IIPortex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and...Abbott MedicalJKA
Z-2652-2023Class IIVenue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4...GE Medical Systems, Israel Ltd.IYN
Z-0093-2024Class IIBD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR...CareFusion 303, IncBRY
Z-0035-2024Class I2008T Hd Sys. W/o Cdx W/bibag BluestarFresenius Medical Care Renal Therapies Group, LLCKDI
Z-0034-2024Class I2008T Hd Sys. W/o Cdx BluestarFresenius Medical Care Renal Therapies Group, LLCKDI
Z-0033-2024Class I2008T Hd Sys. Cdx W/bibag BluestarFresenius Medical Care Renal Therapies Group, LLCKDI
Z-0032-2024Class I2008T Hd Sys. Cdx BluestarFresenius Medical Care Renal Therapies Group, LLCKDI
Z-0031-2024Class I2008T GEN 2 Bibag without CDXFresenius Medical Care Renal Therapies Group, LLCKDI
Z-0030-2024Class I2008T Hemodialysis System w/BibagFresenius Medical Care Renal Therapies Group, LLCKDI
Z-0029-2024Class I2008T Hemodialysis System without CDXFresenius Medical Care Renal Therapies Group, LLCKDI
Z-0036-2024Class IIMeera Mobile Operating Table-to support and position the patient immediately before...Maquet Cardiovascular Us Sales, LLCFQO
Z-0028-2024Class I2008T Hemodialysis SYS, with CDXFresenius Medical Care Renal Therapies Group, LLCKDI
Z-0486-2024Class IIAtrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU...Atrium Medical CorporationCAC
Z-0485-2024Class IIAtrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS...Atrium Medical CorporationKDQ
Z-0101-2024Class IIMAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1Mazor Robotics LtdOLO
Z-0069-2024Class IIZimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome...Zimmer Surgical SAGFD
Z-1884-2025Class IIMale-Female Midsection with the following sizes and model numbers. a. Male-Female...Onkos Surgical, Inc.KRO
Z-1883-2025Class IIEthos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M...Onkos Surgical, Inc.JDI
Z-1882-2025Class IISegmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M...Onkos Surgical, Inc.KRO
Z-1881-2025Class IISegmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M...Onkos Surgical, Inc.KRO
Z-1880-2025Class IISegmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M...Onkos Surgical, Inc.KRO
Z-1879-2025Class IIa. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M...Onkos Surgical, Inc.KRO
Z-1140-2025Class IIBrand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model...Avertix Medical Inc.QBI
Z-0324-2024Class IISolea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with...Convergent DentalNVK