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-1958-2014 | Class II | Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu... | DiaSorin Molecular LLC | OCC | |
| Z-1680-2014 | Class II | Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound... | Xtant Medical Holdings, Inc. | OEI | |
| Z-1522-2015 | Class II | MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan... | Siemens Healthcare Diagnostics Inc. | JWY | |
| Z-1861-2014 | Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF... | NxStage Medical Inc | FKR | |
| Z-1860-2014 | Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF... | NxStage Medical Inc | FKR | |
| Z-1859-2014 | Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF... | NxStage Medical Inc | FKR | |
| Z-1858-2014 | Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF... | NxStage Medical Inc | FKR | |
| Z-1857-2014 | Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF... | NxStage Medical Inc | FKR | |
| Z-1856-2014 | Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF... | NxStage Medical Inc | FKR | |
| Z-1855-2014 | Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF... | NxStage Medical Inc | FKR | |
| Z-1854-2014 | Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF... | NxStage Medical Inc | FKR | |
| Z-1737-2014 | Class II | Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2287-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2286-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2285-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2284-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2283-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2282-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2281-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2280-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2176-2014 | Class III | Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in... | AGFA Healthcare Corp. | IZL | |
| Z-2279-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2278-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2277-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2276-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2275-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2274-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2273-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-2272-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-1949-2014 | Class III | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA)... | Sunrise Medical, Inc. | BZD | |
| Z-2271-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for... | AMO Puerto Rico Manufacturing, Inc. | HQL | |
| Z-1782-2014 | Class II | Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model... | CooperSurgical, Inc. | LKF | |
| Z-1701-2014 | Class II | Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic... | Hologic, Inc. | IZH | |
| Z-1700-2014 | Class II | Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030... | Hologic, Inc. | MUE | |
| Z-1716-2014 | Class II | The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker... | Stryker Corp. | HAW | |
| Z-1715-2014 | Class II | The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components... | Stryker Corp. | HAW | |
| Z-1987-2014 | Class II | Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222 | Microline Surgical, Inc | GEI | |
| Z-1986-2014 | Class II | Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 | Microline Surgical, Inc | GEI | |
| Z-1714-2014 | Class II | Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is... | Canon Medical Systems USA, Inc. | MQB | |
| Z-1805-2014 | Class II | VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873... | Ortho-Clinical Diagnostics, Inc. | DKB | |
| Z-1804-2014 | Class II | VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701... | Ortho-Clinical Diagnostics, Inc. | JIT | |
| Z-1731-2014 | Class II | Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01... | Summit Medical, LLC | ETD | |
| Z-2241-2014 | Class II | Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA | Omni Life Science, Inc. | LZO | |
| Z-1846-2014 | Class II | ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System... | Varian Medical Systems Particle Therapy GmbH | LHN | |
| Z-1985-2014 | Class II | Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and... | Siemens Medical Solutions USA, Inc. | IZL | |
| Z-1824-2014 | Class II | Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 | GE Healthcare | DQA | |
| Z-1718-2014 | Class II | Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci... | Intuitive Surgical, Inc. | NAY | |
| Z-1717-2014 | Class II | Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic... | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-1634-2014 | Class II | CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891... | Terumo Cardiovascular Systems Corporation | DRY | |
| Z-1660-2014 | Class II | LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED... | Physio Control, Inc. | MKJ |