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-0248-2020 | Class II | SAROS Oxygen System Model 3000 | Caire, Inc. | CAW | |
| Z-0545-2020 | Class II | Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution | Abbott Medical | JJE | |
| Z-0544-2020 | Class II | Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution | Abbott Medical | JJE | |
| Z-0543-2020 | Class II | Alinity ci Level Sensor, Bulk Solution | Abbott Medical | JJE | |
| Z-0258-2020 | Class II | The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity... | Draeger Medical Systems, Inc. | MHX | |
| Z-2433-2020 | Class II | CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220... | Codan US Corp. | FPA | |
| Z-1956-2020 | Class II | Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide... | Merit Medical Systems, Inc. | DYB | |
| Z-1509-2020 | Class II | Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only... | Stryker Corp. | GEI | |
| Z-1508-2020 | Class II | Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only... | Stryker Corp. | GEI | |
| Z-0124-2020 | Class II | Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between... | Integra LifeSciences Corporation | GWM | |
| Z-0159-2020 | Class II | Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage... | OLYMPUS Corporation of the Americas | HHI | |
| Z-0567-2021 | Class II | Microsurgical Operating Room Tables;7300BX (18-351-70). | Mizuho America, Inc. | GDC | |
| Z-0566-2021 | Class II | Microsurgical Operating Room Tables;7300B (18-350-70); | Mizuho America, Inc. | GDC | |
| Z-1155-2020 | Class II | Respironics V680 Ventilator, Service # 850011, (OUS Only) | Respironics, Inc. | MNT | |
| Z-1154-2020 | Class II | Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit... | Respironics, Inc. | MNT | |
| Z-1153-2020 | Class II | Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N... | Respironics, Inc. | MNT | |
| Z-1152-2020 | Class II | Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614 | Respironics, Inc. | MNT | |
| Z-1168-2020 | Class II | Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific... | Pacific Medical Group Inc. | HFM | |
| Z-0169-2020 | Class II | OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the... | Omni Life Science, Inc. | LPH | |
| Z-0153-2020 | Class III | Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test... | Roche Diagnostics GmbH | CIG | |
| Z-0152-2020 | Class III | Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product... | Roche Diagnostics GmbH | CIX | |
| Z-1167-2020 | Class II | Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific... | Pacific Medical Group Inc. | HGL | |
| Z-1166-2020 | Class II | Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the... | Pacific Medical Group Inc. | HFM | |
| Z-1165-2020 | Class II | Toco M2734A, that may have been serviced with the following: Pacific Medical Philips... | Pacific Medical Group Inc. | HFM | |
| Z-1164-2020 | Class II | Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific... | Pacific Medical Group Inc. | HGL | |
| Z-1163-2020 | Class II | External Toco Transducer (M1355A), that may have been serviced with the following... | Pacific Medical Group Inc. | HFM | |
| Z-1162-2020 | Class II | Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been... | Pacific Medical Group Inc. | HGL | |
| Z-1161-2020 | Class II | Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been... | Pacific Medical Group Inc. | HGL | |
| Z-1160-2020 | Class II | Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the... | Pacific Medical Group Inc. | HFM | |
| Z-1159-2020 | Class II | Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced... | Pacific Medical Group Inc. | HFM | |
| Z-2956-2020 | Class II | NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system... | Novarad Corp. | LLZ | |
| Z-1272-2020 | Class II | Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model... | Philips North America LLC | MKJ | |
| Z-1271-2020 | Class II | Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 | Philips North America LLC | MKJ | |
| Z-0246-2020 | Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or... | Alto Development Corp | JDQ | |
| Z-0245-2020 | Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation... | Alto Development Corp | JDQ | |
| Z-0244-2020 | Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or... | Alto Development Corp | JDQ | |
| Z-0243-2020 | Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation... | Alto Development Corp | JDQ | |
| Z-0242-2020 | Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or... | Alto Development Corp | JDQ | |
| Z-0269-2020 | Class II | VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain... | Ortho-Clinical Diagnostics, Inc. | CEM | |
| Z-0268-2020 | Class II | VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine... | Ortho-Clinical Diagnostics, Inc. | CGZ | |
| Z-0267-2020 | Class II | VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-)... | Ortho-Clinical Diagnostics, Inc. | CGZ | |
| Z-0168-2020 | Class II | Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the... | Exactech, Inc. | LRN | |
| Z-0209-2020 | Class II | Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant... | Candela Corporation | GEX | |
| Z-0208-2020 | Class II | Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant... | Candela Corporation | GEX | |
| Z-0207-2020 | Class II | Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C... | Candela Corporation | GEX | |
| Z-0206-2020 | Class II | Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant... | Candela Corporation | GEX | |
| Z-0172-2020 | Class I | Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case... | MedTech SAS | HAW | |
| Z-0233-2020 | Class II | Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1)... | ConvaTec Limited | EXE | |
| Z-2756-2019 | Class II | MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline... | MEDLINE INDUSTRIES, LP - Northfield | LWK | |
| Z-0369-2020 | Class II | Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used... | Mavidon Medical Prod | KOY |