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-0808-05 | Medtronic Custom Packs and Total System Packs. Pack can contain a number of different... | Medtronic Perfusion Systems | DWE | ||
| Z-0660-2007 | 8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and... | Intuitive Surgical, Inc. | NAY | ||
| Z-0367-06 | 10 cm Scopable Catheter Reservoir | Phoenix Biomedical Corp. | HCA | ||
| Z-0366-06 | 7 cm Catheter Reservoir with 10 cm extension | Phoenix Biomedical Corp. | HCA | ||
| Z-0365-06 | 6 cm Catheter Reservoir with 10 cm extension | Phoenix Biomedical Corp. | HCA | ||
| Z-0878-05 | Servo-i Ventilator | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-0894-05 | IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of... | Abbott Diagnostic International, Ltd. | JHI | ||
| Z-0893-05 | AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle... | Abbott Diagnostic International, Ltd. | JHI | ||
| Z-0624-06 | In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100... | Abbott Diagnostic International, Ltd. | MGU | ||
| Z-0841-05 | Continuum MR Compatible Infusion Pump. Pump Model #3009135 | Medrad, Inc. | FRN | ||
| Z-0842-05 | The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DXE | ||
| Z-0205-06 | Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674. | Namsa | FRC | ||
| Z-0774-05 | Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number... | MEDLINE INDUSTRIES, LP - Northfield | LRO | ||
| Z-0773-05 | Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number... | MEDLINE INDUSTRIES, LP - Northfield | LRO | ||
| Z-0772-05 | Medline Custom Anesthesia Circuit Adult 40in Mask 3L Kit (non-sterile), reorder number... | MEDLINE INDUSTRIES, LP - Northfield | LRO | ||
| Z-0771-05 | Medline Custom Anesthesia Set Up Kit - Latex Free (non-sterile), reorder number... | MEDLINE INDUSTRIES, LP - Northfield | LRO | ||
| Z-0770-05 | Medline Custom Anesthesia Super Circuit Adult 60 Unilimb Kit (non-sterile), reorder... | MEDLINE INDUSTRIES, LP - Northfield | LRO | ||
| Z-0769-05 | Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which... | MEDLINE INDUSTRIES, LP - Northfield | LRO | ||
| Z-2079-2008 | Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts... | Howmedica Osteonics Corp | JWH | ||
| Z-0667-05 | Terumo Advanced Perfusion System 1 (with 6 inch diameter roller pump); Catalog number... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0666-05 | Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0199-06 | Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150... | Baxter Healthcare Corporation | FPA | ||
| Z-0684-2007 | Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with... | E.M.S. - Electro Medical Systems SA | FFK | ||
| Z-0835-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0834-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0833-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0832-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0831-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0830-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0829-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0828-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0827-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0826-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0825-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0918-05 | Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N... | Ebi, LLC | HXI | ||
| Z-0917-05 | EBI Ball Tip Guide Wire 3.2mm x 98cm found in the Holland Nail Flexible Reamer Accessory... | Ebi, LLC | HXI | ||
| Z-0916-05 | EBI Ball Tip Guide Wire 3.2mm x 55cm found in the Ankle Arthrodesis Nail Instr., Part... | Ebi, LLC | HXI | ||
| Z-0784-05 | Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin... | Diasorin Inc. | LIP | ||
| Z-0928-05 | BD 25G Spinal Needles. (Spinal Anesthesia Needle) | Becton Dickinson & Co | BSP | ||
| Z-0824-05 | Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S... | Abbott Medical | DPS | ||
| Z-0912-05 | i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting... | Abbott Medical | JBP | ||
| Z-0779-05 | Cidexplus Solution Test Strips | Advanced Sterilization Products | JOJ | ||
| Z-1392-05 | ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the... | Abbott Medical | JHI | ||
| Z-0913-05 | VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells... | Ortho-Clinical Diagnostics, Inc. | KLI | ||
| Z-1023-05 | Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-1022-05 | Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-0799-05 | Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product... | Spectramed, LLC | EGJ | ||
| Z-0112-06 | Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management... | Boston Scientific Corporation | DQK | ||
| Z-1546-05 | SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for... | Chdiagnostics, LLC | LFR | ||
| Z-0895-05 | FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with... | FHC, Inc. | HAW |