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-1493-2018 | Class II | Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers | Beijing Syntech Laser Co., Ltd | GEX | |
| Z-1492-2018 | Class II | Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers | Beijing Syntech Laser Co., Ltd | GEX | |
| Z-1491-2018 | Class II | Beijing Syntech Laser UL C02 Laser surgical lasers | Beijing Syntech Laser Co., Ltd | GEX | |
| Z-1490-2018 | Class II | Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers | Beijing Syntech Laser Co., Ltd | GEX | |
| Z-1489-2018 | Class II | Beijing Syntech Laser Trixel C02 Laser surgical lasers | Beijing Syntech Laser Co., Ltd | GEX | |
| Z-1488-2018 | Class II | Beijing Syntech Laser Diode Laser surgical lasers | Beijing Syntech Laser Co., Ltd | GEX | |
| Z-0581-2018 | Class II | AVID Medical QA Pack AV10654-10 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0441-2019 | Class II | Heron toilet and bath chair Model 880505-01 & 880505-11 | R82 a/S | INM | |
| Z-0812-2018 | Class II | 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL... | ZOLL Medical Corporation | CBK | |
| Z-0993-2018 | Class II | JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty | Zimmer GmbH | LZO | |
| Z-0992-2018 | Class II | DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty | Zimmer GmbH | LZO | |
| Z-3050-2017 | Class II | ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens... | Alcon Laboratories | NCF | |
| Z-3049-2017 | Class II | ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular... | Alcon Laboratories | NCF | |
| Z-3110-2017 | Class II | MOSAIQ Medical Charged-Particle Radiation Therapy System | Elekta Limited | LHN | |
| Z-2776-2017 | Class II | STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz | LivaNova USA, Inc. | DWC | |
| Z-2775-2017 | Class II | STOCKERT Heater-Cooler System 3T, 120V/60 Hz | LivaNova USA, Inc. | DWC | |
| Z-2774-2017 | Class II | STOCKERT Heater-Cooler System 3T, 127V/60 Hz | LivaNova USA, Inc. | DWC | |
| Z-2773-2017 | Class II | STOCKERT Heater-Cooler System 3T, 208V/60 Hz | LivaNova USA, Inc. | DWC | |
| Z-2772-2017 | Class II | STOCKERT Heater-Cooler System 3T, 240V/60 Hz | LivaNova USA, Inc. | DWC | |
| Z-2771-2017 | Class II | STOCKERT Heater-Cooler System 3T, 230 V | LivaNova USA, Inc. | DWC | |
| Z-3030-2017 | Class II | VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary... | CareFusion 303, Inc | FPA | |
| Z-1662-2018 | Class II | Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens... | Siemens Healthcare Diagnostics Inc. | NRP | |
| Z-1661-2018 | Class II | Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens... | Siemens Healthcare Diagnostics Inc. | MLM | |
| Z-1660-2018 | Class II | Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens... | Siemens Healthcare Diagnostics Inc. | KLI | |
| Z-1659-2018 | Class II | Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr... | Siemens Healthcare Diagnostics Inc. | CGS | |
| Z-1658-2018 | Class II | Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens... | Siemens Healthcare Diagnostics Inc. | CFR | |
| Z-1657-2018 | Class II | Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148)... | Siemens Healthcare Diagnostics Inc. | CIT | |
| Z-1656-2018 | Class II | Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565)... | Siemens Healthcare Diagnostics Inc. | CKA | |
| Z-1655-2018 | Class II | Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens... | Siemens Healthcare Diagnostics Inc. | JIF | |
| Z-1654-2018 | Class II | Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare... | Siemens Healthcare Diagnostics Inc. | CIG | |
| Z-1653-2018 | Class II | Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens... | Siemens Healthcare Diagnostics Inc. | CGS | |
| Z-1652-2018 | Class II | Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare... | Siemens Healthcare Diagnostics Inc. | CFR | |
| Z-1651-2018 | Class II | Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr... | Siemens Healthcare Diagnostics Inc. | CIT | |
| Z-1650-2018 | Class II | Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr... | Siemens Healthcare Diagnostics Inc. | CKA | |
| Z-1649-2018 | Class II | Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare... | Siemens Healthcare Diagnostics Inc. | JIF | |
| Z-1648-2018 | Class II | ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of... | Siemens Healthcare Diagnostics Inc. | DKJ | |
| Z-1647-2018 | Class II | ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure... | Siemens Healthcare Diagnostics Inc. | CKA | |
| Z-1646-2018 | Class II | ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to... | Siemens Healthcare Diagnostics Inc. | JIF | |
| Z-0378-2018 | Class II | Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series... | Roche Diagnostics GmbH | JJE | |
| Z-0312-2018 | Class II | PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS)... | Zimmer GmbH | LPH | |
| Z-3143-2017 | Class II | Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and... | Medtronic Navigation, Inc | OLO | |
| Z-3142-2017 | Class II | Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a... | Medtronic Navigation, Inc | OLO | |
| Z-3141-2017 | Class II | Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a... | Medtronic Navigation, Inc | OLO | |
| Z-3140-2017 | Class II | Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a... | Medtronic Navigation, Inc | OLO | |
| Z-3139-2017 | Class II | Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic... | Medtronic Navigation, Inc | OLO | |
| Z-2798-2017 | Class II | Non-Sterile Sample, Sorin Group, Smart Perfusion Pack, Ref 627376401, 1 Ea, Not for... | LivaNova USA, Inc. | DWE | |
| Z-2797-2017 | Class II | Non-Sterile Sample, Sorin Group, Smart Cardioplegia, Cardioplegia Pack, Ref 627366901, 1... | LivaNova USA, Inc. | DWE | |
| Z-2796-2017 | Class II | Non-Sterile Sample, Sorin Group, Smart Perfusion Pack, Inspire 8Fs, Ref 044043700, 1 Ea... | LivaNova USA, Inc. | DWE | |
| Z-2795-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx... | LivaNova USA, Inc. | DWE | |
| Z-2794-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA | LivaNova USA, Inc. | DWE |