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-3023-2018 | Class II | fMRI Hardware System VisualSystem allows video signals from the stimulus presentation... | NordicNeuroLab AS | LNH | |
| Z-0070-2019 | Class II | EEA Circular Stapler with Tri-Staple Technology, Part No... | Medtronic, Inc. | GAG | |
| Z-0414-2019 | Class III | BioMend Extend, REF# 0142Z, Synthetic bone grafting material. | Collagen Matrix, Inc | LYC | |
| Z-3253-2018 | Class III | Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 | Medtronic, Inc. | DQO | |
| Z-0366-2020 | Class II | TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01)... | Trimed Inc | HRS | |
| Z-2359-2019 | Class II | MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole... | Agilent Technologies, Inc. | DOP | |
| Z-3245-2018 | Class II | DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography... | Agfa N.V. | KPR | |
| Z-0080-2019 | Class II | VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative... | Ortho-Clinical Diagnostics, Inc. | JLW | |
| Z-0079-2019 | Class II | VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative... | Ortho-Clinical Diagnostics, Inc. | JLW | |
| Z-3025-2018 | Class II | da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product... | Intuitive Surgical, Inc. | NAY | |
| Z-3024-2018 | Class II | da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product... | Intuitive Surgical, Inc. | NAY | |
| Z-3178-2018 | Class II | Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d)... | Permobil, AB | ITI | |
| Z-0362-2020 | Class II | TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20... | Tec Com GmbH | DWJ | |
| Z-0609-2020 | Class II | Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50... | Lens.com, Inc. | LPM | |
| Z-0217-2019 | Class II | Streamlab - Refrigerated Storage Module 15000 | Siemens Healthcare Diagnostics Inc. | LXG | |
| Z-0216-2019 | Class II | Streamlab - Refrigerated Storage Module 9000 | Siemens Healthcare Diagnostics Inc. | LXG | |
| Z-0215-2019 | Class II | Streamlab Core Unit / Lynx with Iom | Siemens Healthcare Diagnostics Inc. | LXG | |
| Z-0214-2019 | Class II | Aptio Rack Output Module | Siemens Healthcare Diagnostics Inc. | LXG | |
| Z-0213-2019 | Class II | Aptio 9000 Refrigerated Storage Module | Siemens Healthcare Diagnostics Inc. | LXG | |
| Z-0212-2019 | Class II | Aptio 15000 Refrigerated Storage Module | Siemens Healthcare Diagnostics Inc. | LXG | |
| Z-0211-2019 | Class II | Aptio Centrifuge Module | Siemens Healthcare Diagnostics Inc. | LXG | |
| Z-0210-2019 | Class II | Aptio Rack Input Module | Siemens Healthcare Diagnostics Inc. | LXG | |
| Z-0209-2019 | Class II | Aptio Input/output Module | Siemens Healthcare Diagnostics Inc. | LXG | |
| Z-2995-2018 | Class II | Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style... | Ohio Medical LLC | BTA | |
| Z-0268-2019 | Class II | CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400 | Manus Medical, LLC | LRO | |
| Z-0267-2019 | Class II | CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112 | Manus Medical, LLC | LRO | |
| Z-0266-2019 | Class II | CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN... | Manus Medical, LLC | LRO | |
| Z-0265-2019 | Class II | CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN... | Manus Medical, LLC | LRO | |
| Z-0264-2019 | Class II | CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L | Manus Medical, LLC | LRO | |
| Z-0263-2019 | Class II | CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884 | Manus Medical, LLC | LRO | |
| Z-0262-2019 | Class II | CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914 | Manus Medical, LLC | LRO | |
| Z-0261-2019 | Class II | CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000 | Manus Medical, LLC | LRO | |
| Z-0260-2019 | Class II | CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B | Manus Medical, LLC | LRO | |
| Z-0259-2019 | Class II | CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B | Manus Medical, LLC | LRO | |
| Z-0258-2019 | Class II | CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538 | Manus Medical, LLC | LRO | |
| Z-0257-2019 | Class II | CHS Custom Convenience Kit- COBAN, LF (1"X5 YDS) Product Number:D5-14591 | Manus Medical, LLC | LRO | |
| Z-0256-2019 | Class II | CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669 | Manus Medical, LLC | LRO | |
| Z-0255-2019 | Class II | CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520 | Manus Medical, LLC | LRO | |
| Z-0254-2019 | Class II | CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664 | Manus Medical, LLC | LRO | |
| Z-0253-2019 | Class II | CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685 | Manus Medical, LLC | LRO | |
| Z-0252-2019 | Class II | CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C | Manus Medical, LLC | LRO | |
| Z-0251-2019 | Class II | CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000 | Manus Medical, LLC | LRO | |
| Z-0250-2019 | Class II | CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02 | Manus Medical, LLC | LRO | |
| Z-0249-2019 | Class II | (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS... | Manus Medical, LLC | LRO | |
| Z-0248-2019 | Class II | CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914 | Manus Medical, LLC | LRO | |
| Z-0247-2019 | Class II | CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635 | Manus Medical, LLC | LRO | |
| Z-0246-2019 | Class II | CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178 | Manus Medical, LLC | LRO | |
| Z-0245-2019 | Class II | CHS Custom Convenience Kit-SPECIALIST CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP | Manus Medical, LLC | LRO | |
| Z-0244-2019 | Class II | CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product... | Manus Medical, LLC | LRO | |
| Z-0243-2019 | Class II | CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B | Manus Medical, LLC | LRO |