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-0053-04 | e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine... | Siemens Medical Solutions USA, Inc. | KPS-- | ||
| Z-0041-04 | SONOLINE Antares Diagnostic Ultrasound System. | Siemens Medical Solutions USA, Inc. | |||
| Z-1481-04 | Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator | Advanced Sterilization Products | JOJ | ||
| Z-1026-04 | Synchron Systems Acetaminophen Reagent, part No. 472169. | Siemens Healthcare Diagnostics Inc. | LDP | ||
| Z-0570-04 | Template Needle, Series 17, 20 cm, with Threaded Female hub and Bent Stylet, Closed-End... | Alpha Omega Services Inc | MIJ | ||
| Z-1480-04 | Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products'' | Advanced Sterilization Products | JOJ | ||
| Z-1479-04 | Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX PLUS Products'' | Advanced Sterilization Products | JOJ | ||
| Z-1278-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1277-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1276-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1275-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1274-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1273-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1272-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1271-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1270-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1269-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1268-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1267-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1266-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1265-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1264-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1263-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1262-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1261-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1260-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1259-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1258-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-1257-03 | ETHICON brand surgical device with an added label with the labeling Manufactured by... | International Surgical Supply, Inc. | KDC | ||
| Z-0028-04 | Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in... | Roche Diagnostics GmbH | LNN | ||
| Z-1226-03 | Model M4735A HeartStart XL Defibrillator//Monitor | Philips North America LLC | MKJ | ||
| Z-1237-04 | 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #ANBSM-0048. | The Daavlin Distributing Co. | FTC | ||
| Z-1236-04 | 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #SNBSM-0048. | The Daavlin Distributing Co. | FTC | ||
| Z-1235-04 | 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #LNBH-0048. | The Daavlin Distributing Co. | FTC | ||
| Z-1234-04 | 3 Series Full Body Phototherapy Device with Smart Touch Control System, Model All Touch... | The Daavlin Distributing Co. | FTC | ||
| Z-1233-04 | 3 Series Full Body Phototherapy Device with Smart Touch Control System, Models... | The Daavlin Distributing Co. | FTC | ||
| Z-0168-04 | Paradigm Model 511 and 512 Insulin Infusion Pumps | Medtronic, Inc. | LZG | ||
| Z-0565-04 | Cordis Biopsy Forceps 7F 104 cm Standard, Product Number 504300L | Cordis US Corp. | GEN | ||
| Z-0564-04 | CordisEndomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number 504300L | Cordis US Corp. | GEN | ||
| Z-0027-04 | Lactate Disposable Membrane Caps Product Number: 0018108400 | Instrumentation Laboratory Co. | LNW | ||
| Z-0059-04 | FLEXICAIR MC3 Low Airloss Therapy unit | Hill-Rom Manufacturing, Inc. | IOQ | ||
| Z-0058-04 | FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the... | Hill-Rom Manufacturing, Inc. | IOQ | ||
| Z-0046-04 | Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0936-04 | Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20... | Surgical Specialties Corp | GAT | ||
| Z-1280-03 | Phaco Needles, catalog #DP8115, with 15 degree needle taper, labeld in... | Bausch & Lomb Incorporated | HQC | ||
| Z-1279-03 | Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part... | Bausch & Lomb Incorporated | HQC | ||
| Z-0313-04 | Easypump LT 100-200 Elastomeric Infusion Pump (100 ml x 0.5 ml/hr) Part number: 5001120 | Halyard Health | MEB | ||
| Z-1218-03 | AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for... | Abbott Medical | LPS | ||
| Z-0026-04 | Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The... | Surgical Specialties Corp | HNN | ||
| Z-0002-04 | Opti-Plast Balloon Dilatation Catheters | Bard Peripheral Vascular Inc | GBR |