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-2205-2016 | Class II | 6.0mm Round Fluted Bur, Super Long | Stryker Corp. | HBE | |
| Z-2204-2016 | Class II | 5.0mm Round Fluted Bur, Super Long | Stryker Corp. | HBE | |
| Z-2391-2016 | Class II | Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with... | Halyard Health | GXI | |
| Z-2529-2016 | Class II | AB SCIEX QTRAP 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic... | AB Sciex, LLC | DOP | |
| Z-2528-2016 | Class II | AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic... | AB Sciex, LLC | DOP | |
| Z-2527-2016 | Class II | AB SCIEX 3200MD QTRAP LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic... | AB Sciex, LLC | DOP | |
| Z-2526-2016 | Class II | AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF)... | AB Sciex, LLC | DOP | |
| Z-2200-2016 | Class II | Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog... | Medtronic, Inc. | LDF | |
| Z-1943-2020 | Class II | EVA Floor Lifts, Model Numbers: 400, 450, 600 | Direct Healthcare Group Sverige AB | FSA | |
| Z-2749-2016 | Class II | Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI... | Boston Scientific Corporation | LWP | |
| Z-2689-2016 | Class II | A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or... | Datascope Corp. | BSZ | |
| Z-2218-2016 | Class II | Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for... | Smith & Nephew, Inc. | NBH | |
| Z-2253-2016 | Class II | Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping... | The Anspach Effort, Inc. | HBC | |
| Z-2376-2016 | Class II | Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered... | Hill-Rom Inc. | FNL | |
| Z-2536-2016 | Class II | Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and... | Stryker Corp. | NDN | |
| Z-2110-2016 | Class II | Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore... | Philips North America LLC | JAK | |
| Z-2109-2016 | Class II | Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore... | Philips North America LLC | JAK | |
| Z-2235-2016 | Class II | T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip... | WalkMed Technologies, LLC | FPA | |
| Z-2234-2016 | Class II | T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50... | WalkMed Technologies, LLC | FPA | |
| Z-2233-2016 | Class II | T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches... | WalkMed Technologies, LLC | FPA | |
| Z-2232-2016 | Class II | T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches... | WalkMed Technologies, LLC | FPA | |
| Z-2231-2016 | Class II | T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip... | WalkMed Technologies, LLC | FPA | |
| Z-2230-2016 | Class II | T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with... | WalkMed Technologies, LLC | FPA | |
| Z-2229-2016 | Class II | T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches... | WalkMed Technologies, LLC | FPA | |
| Z-2228-2016 | Class II | T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per... | WalkMed Technologies, LLC | FPA | |
| Z-2227-2016 | Class II | T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per... | WalkMed Technologies, LLC | FPA | |
| Z-2226-2016 | Class II | T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged in a Tyvek... | WalkMed Technologies, LLC | FPA | |
| Z-2225-2016 | Class II | T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a... | WalkMed Technologies, LLC | FPA | |
| Z-2224-2016 | Class II | T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek pouch, with... | WalkMed Technologies, LLC | FPA | |
| Z-2223-2016 | Class II | T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per... | WalkMed Technologies, LLC | FPA | |
| Z-2222-2016 | Class II | T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches... | WalkMed Technologies, LLC | FPA | |
| Z-2221-2016 | Class II | Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per... | WalkMed Technologies, LLC | FPA | |
| Z-2220-2016 | Class II | The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes... | WalkMed Technologies, LLC | FRN | |
| Z-2219-2016 | Class II | The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes... | WalkMed Technologies, LLC | FRN | |
| Z-2751-2016 | Class II | Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom... | Biomet Microfixation | KKY | |
| Z-2351-2016 | Class II | Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and... | Richard-Allan Scientific LLC | IFP | |
| Z-2051-2016 | Class II | ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part... | Cardiovascular Systems Incorporated | MCW | |
| Z-2240-2016 | Class II | TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet... | Zimmer GmbH | JDO | |
| Z-2602-2016 | Class II | Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) &... | Medtronic Neuromodulation | MHY | |
| Z-2099-2016 | Class II | Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic... | Agilent Technologies, Inc. | NYQ | |
| Z-2690-2016 | Class II | FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner... | FUJIFILM Healthcare Americas Corporation | MUE | |
| Z-2244-2016 | Class II | Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion... | Medrad, Inc. | DXT | |
| Z-0715-2017 | Class II | Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The... | Boston Scientific Corporation | LJS | |
| Z-0714-2017 | Class II | Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The... | Boston Scientific Corporation | LJS | |
| Z-2131-2016 | Class II | GE Healthcare, Discovery MR750w | GE Healthcare | LNH | |
| Z-2108-2016 | Class II | Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic... | Siemens Healthcare Diagnostics Inc. | CDP | |
| Z-2210-2016 | Class II | Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a... | Terumo Cardiovascular Systems Corporation | DWC | |
| Z-2209-2016 | Class II | Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a... | Terumo Cardiovascular Systems Corporation | DWC | |
| Z-2208-2016 | Class II | Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of... | Terumo Cardiovascular Systems Corporation | DWC | |
| Z-2207-2016 | Class II | HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System... | Terumo Cardiovascular Systems Corporation | DWC |