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-1884-2014 | Class II | ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is... | The Anspach Effort, Inc. | HBE | |
| Z-1883-2014 | Class II | ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to... | The Anspach Effort, Inc. | HBE | |
| Z-1882-2014 | Class II | ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** This device is... | The Anspach Effort, Inc. | HBE | |
| Z-1881-2014 | Class II | ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used... | The Anspach Effort, Inc. | HBE | |
| Z-1880-2014 | Class II | ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be... | The Anspach Effort, Inc. | HBE | |
| Z-1879-2014 | Class II | ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to... | The Anspach Effort, Inc. | HBE | |
| Z-1878-2014 | Class II | ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This... | The Anspach Effort, Inc. | HBE | |
| Z-1877-2014 | Class II | ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device... | The Anspach Effort, Inc. | HBE | |
| Z-1876-2014 | Class II | ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with... | The Anspach Effort, Inc. | MBI | |
| Z-1875-2014 | Class II | ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is... | The Anspach Effort, Inc. | MBI | |
| Z-0977-2013 | Class II | BS-200 Chemistry Analyzer Designed for clinical laboratory use. | Datascope Corp. | CFR | |
| Z-0798-2013 | Class II | Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part... | Datascope Corp. | MSX | |
| Z-0913-2013 | Class II | Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0762-2013 | Class II | COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. | Roche Molecular Systems Inc | MWA | |
| Z-0648-2013 | Class III | Immunoradiometric assay. Device is an immunoradiometric assay designed for the... | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-0647-2013 | Class III | Immunoradiometric assay. | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-0646-2013 | Class III | Immunoradiometric assay. Device is an immunoradiometric assay designed for the... | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-0569-2013 | Class II | Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector... | Depuy Orthopaedics Inc. | LPH | |
| Z-1930-2013 | Class II | TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej... | Radiometer America, Inc | LPP | |
| Z-1065-2013 | Class II | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-1064-2013 | Class II | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0948-2013 | Class II | Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0957-2013 | Class II | Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is... | Siemens Healthcare Diagnostics Inc. | MLM | |
| Z-0992-2013 | Class II | Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-0797-2013 | Class II | Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1... | Manus Medical, LLC | FCH | |
| Z-0796-2013 | Class II | Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20... | Manus Medical, LLC | FCH | |
| Z-0684-2013 | Class III | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0683-2013 | Class III | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0682-2013 | Class III | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0681-2013 | Class III | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0680-2013 | Class III | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0679-2013 | Class III | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0678-2013 | Class III | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0690-2013 | Class II | Microplate, truncated V-bottomed lots included in the above listed products Product... | Revvity Health Sciences, Inc. | ||
| Z-0689-2013 | Class II | DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010 | Revvity Health Sciences, Inc. | ||
| Z-0688-2013 | Class II | NEONATAL TOTAL GALACTOSE KIT Product Numbers... | Revvity Health Sciences, Inc. | JLA | |
| Z-0687-2013 | Class II | NEOBASE NON-DERIVATIZED MSMS KIT Product Number... | Revvity Health Sciences, Inc. | NQL | |
| Z-0686-2013 | Class II | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number... | Revvity Health Sciences, Inc. | JNB | |
| Z-0677-2013 | Class III | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0563-2013 | Class II | CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer... | Agilent Technologies Denmark ApS | KPA | |
| Z-0676-2013 | Class III | Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0528-2014 | Class III | Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs... | Remel Inc | JTN | |
| Z-1660-2013 | Class II | Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a... | Merit Medical Systems, Inc. | LRO | |
| Z-0641-2013 | Class II | Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix Positive... | Siemens Healthcare Diagnostics Inc. | JJW | |
| Z-0640-2013 | Class II | Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix... | Siemens Healthcare Diagnostics Inc. | JJW | |
| Z-0639-2013 | Class II | Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix... | Siemens Healthcare Diagnostics Inc. | JJW | |
| Z-0638-2013 | Class II | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed... | Siemens Healthcare Diagnostics Inc. | JJW | |
| Z-0637-2013 | Class II | Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix Positive and Negative... | Siemens Healthcare Diagnostics Inc. | JJW | |
| Z-0636-2013 | Class II | Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog... | Siemens Healthcare Diagnostics Inc. | JJW | |
| Z-0635-2013 | Class II | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog... | Siemens Healthcare Diagnostics Inc. | JJW |