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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1597-2020 | Class II | MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information... | Elekta Limited | MUJ | |
| Z-0585-2020 | Class II | 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 | Vygon Mfg | PND | |
| Z-0265-2020 | Class II | SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2496-2020 | Class II | TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and... | TOMTEC Imaging Systems GmbH | LLZ | |
| Z-0367-2020 | Class III | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. | Randox Laboratories, Limited | JLG | |
| Z-0581-2020 | Class II | Atellica CH 930 Analyzer | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1149-2020 | Class II | Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for... | Blue Ortho | OLO | |
| Z-2006-2020 | Class II | Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE... | Ra Medical Systems,Inc | PDU | |
| Z-0217-2020 | Class I | Forte Gamma Camera System is intended to produce images depicting the anatomical... | Philips North America LLC | KPS | |
| Z-0216-2020 | Class I | Forte Gamma Camera System is intended to produce images depicting the anatomical... | Philips North America LLC | KPS | |
| Z-0215-2020 | Class I | Forte Gamma Camera System is intended to produce images depicting the anatomical... | Philips North America LLC | KPS | |
| Z-0214-2020 | Class I | Forte Gamma Camera System is intended to produce images depicting the anatomical... | Philips North America LLC | KPS | |
| Z-0213-2020 | Class I | Forte Gamma Camera System is intended to produce images depicting the anatomical... | Philips North America LLC | KPS | |
| Z-0212-2020 | Class II | MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm | Crossroads Extremity Systems LLC | HWC | |
| Z-0985-2020 | Class II | Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250 | Pacific Medical Group Inc. | HGM | |
| Z-0984-2020 | Class II | Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250 | Pacific Medical Group Inc. | HGM | |
| Z-0983-2020 | Class II | Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260 | Pacific Medical Group Inc. | HGM | |
| Z-0982-2020 | Class II | Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660 | Pacific Medical Group Inc. | HGM | |
| Z-0981-2020 | Class II | Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205 | Pacific Medical Group Inc. | HGM | |
| Z-0980-2020 | Class II | Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260 | Pacific Medical Group Inc. | HFM | |
| Z-0979-2020 | Class II | Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205 | Pacific Medical Group Inc. | HFM | |
| Z-0151-2020 | Class II | Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory | Xodus Medical Inc | GEI | |
| Z-0150-2020 | Class II | Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory | Xodus Medical Inc | GEI | |
| Z-0149-2020 | Class II | Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory | Xodus Medical Inc | GEI | |
| Z-0247-2020 | Class II | TherMax Blood Warmer Unit | Baxter Healthcare Corporation | KDI | |
| Z-1804-2020 | Class II | iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging... | Boston Scientific Corporation | DQK | |
| Z-0287-2020 | Class III | Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples. | Biomedical Polymers, Inc. | LXG | |
| Z-0286-2020 | Class III | Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples. | Biomedical Polymers, Inc. | LXG | |
| Z-0505-2020 | Class II | XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product... | Boston Scientific Corporation | LJT | |
| Z-0504-2020 | Class II | BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022 | Boston Scientific Corporation | LJT | |
| Z-0503-2020 | Class II | BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product... | Boston Scientific Corporation | LJT | |
| Z-0502-2020 | Class II | BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product... | Boston Scientific Corporation | LJT | |
| Z-0501-2020 | Class II | BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product... | Boston Scientific Corporation | LJT | |
| Z-0584-2020 | Class II | In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP... | GN Hearing A/S | ESD | |
| Z-0583-2020 | Class II | Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW... | GN Hearing A/S | ESD | |
| Z-0251-2020 | Class II | Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor | Senseonics, Inc. | QHJ | |
| Z-0513-2020 | Class II | EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per... | MEDLINE INDUSTRIES, LP - Northfield | CGA | |
| Z-0167-2020 | Class II | EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and... | Baxter Healthcare Corporation | LHI | |
| Z-0506-2020 | Class II | Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage... | Cook Incorporated | JOL | |
| Z-2650-2023 | Class II | IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during... | Icecure Medical Ltd | GEH | |
| Z-1754-2020 | Class II | KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be... | KT Health, LLC | IME | |
| Z-1442-2020 | Class I | BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol... | CME America, LLC | FRN | |
| Z-0828-2020 | Class II | Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140 | Medicrea International | KWP | |
| Z-0827-2020 | Class II | Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130 | Medicrea International | KWP | |
| Z-0744-2020 | Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000... | Axis-Shield Diagnostics, Ltd. | LPS | |
| Z-0743-2020 | Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100... | Axis-Shield Diagnostics, Ltd. | LPS | |
| Z-0742-2020 | Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product... | Axis-Shield Diagnostics, Ltd. | LPS | |
| Z-0223-2020 | Class II | Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in... | Synthes (USA) Products LLC | NKG | |
| Z-0257-2020 | Class II | CardioLab/ComboLab Recording Systems | GE Healthcare | DQK | |
| Z-0285-2020 | Class II | 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI... | Becton Dickinson & Co | NIE |