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-1484-2026 | Class II | Atellica CH Urine Albumin (UAlb). Material Number: 11537225 | Siemens Healthcare Diagnostics Inc. | JIR | |
| Z-1543-2026 | Class II | GEM Premier 5000; Part No. 00055445010 & 00055445011. | Instrumentation Laboratory Co. | CHL | |
| Z-1542-2026 | Class II | GEM Premier 5000; Part No. 00055445008. | Instrumentation Laboratory Co. | CHL | |
| Z-1541-2026 | Class II | GEM Premier 5000; Part No. 00055445004. | Instrumentation Laboratory Co. | CHL | |
| Z-1540-2026 | Class II | GEM Premier 5000; Part No. 00055430011. | Instrumentation Laboratory Co. | CHL | |
| Z-1539-2026 | Class II | GEM Premier 5000; Model No. 00055430010. | Instrumentation Laboratory Co. | CHL | |
| Z-1538-2026 | Class II | GEM Premier 5000; Part No. 00055430008. | Instrumentation Laboratory Co. | CHL | |
| Z-1537-2026 | Class II | GEM Premier 5000; Part No. 00055430004. | Instrumentation Laboratory Co. | CHL | |
| Z-1536-2026 | Class II | GEM Premier 5000; Part No: 00055415011. | Instrumentation Laboratory Co. | CHL | |
| Z-1535-2026 | Class II | GEM Premier 5000; Part No. 00055415010. | Instrumentation Laboratory Co. | CHL | |
| Z-1534-2026 | Class II | GEM Premier 5000; Part No. 00055415008. | Instrumentation Laboratory Co. | CHL | |
| Z-1533-2026 | Class II | GEM Premier 5000; Part No. 00055415005. | Instrumentation Laboratory Co. | CHL | |
| Z-1532-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055415004. | Instrumentation Laboratory Co. | CHL | |
| Z-1531-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407511. | Instrumentation Laboratory Co. | CHL | |
| Z-1530-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407510. | Instrumentation Laboratory Co. | CHL | |
| Z-1529-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407508. | Instrumentation Laboratory Co. | CHL | |
| Z-1528-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055407504. | Instrumentation Laboratory Co. | CHL | |
| Z-1527-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055360011. | Instrumentation Laboratory Co. | CHL | |
| Z-1526-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055360010. | Instrumentation Laboratory Co. | CHL | |
| Z-1525-2026 | Class II | GEM Premier 5000 PAK; Part No. 00055360008. | Instrumentation Laboratory Co. | CHL | |
| Z-1524-2026 | Class II | GEM Premier 5000 PAK, Part No. 00055360004. | Instrumentation Laboratory Co. | CHL | |
| Z-1476-2026 | Class II | cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample... | Roche Diagnostics GmbH | JJE | |
| Z-1475-2026 | Class II | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers... | GE Healthcare | LLZ | |
| Z-1354-2026 | Class I | Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the... | OLYMPUS Corporation of the Americas | HIF | |
| Z-1353-2026 | Class I | Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the... | OLYMPUS Corporation of the Americas | HIF | |
| Z-1352-2026 | Class I | Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the... | OLYMPUS Corporation of the Americas | HIF | |
| Z-1365-2026 | Class II | Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment... | Integra LifeSciences Corporation | FRO | |
| Z-1364-2026 | Class II | MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2)... | Integra LifeSciences Corporation | FRO | |
| Z-1363-2026 | Class II | MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2)... | Integra LifeSciences Corporation | FRO | |
| Z-1460-2026 | Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET... | Encore Medical, LP | PHX | |
| Z-1459-2026 | Class II | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog... | Encore Medical, LP | JWH | |
| Z-1458-2026 | Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT... | Encore Medical, LP | KWS | |
| Z-1495-2026 | Class II | MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010 | KOB GmbH | ITG | |
| Z-1485-2026 | Class II | Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog... | Aesculap Inc | GWG | |
| Z-1462-2026 | Class II | PIE PAK Models: P2HC-A, P2HC-S, P2HC | Edermy LLC | KPL | |
| Z-1461-2026 | Class II | PIE Trolley System Model: 2005 | Edermy LLC | KPL | |
| Z-1473-2026 | Class II | Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number... | Medtronic Perfusion Systems | MWS | |
| Z-1368-2026 | Class II | Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number... | Baxter Healthcare Corporation | FRN | |
| Z-1341-2026 | Class II | Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA... | Laerdal Medical a/S | JCX | |
| Z-1523-2026 | Class II | Endo-Model Replacement Plateau; Item Number: 15-0027/16; | Waldemar Link GmbH & Co. KG | KRO | |
| Z-1522-2026 | Class II | Endo-Model Replacement Plateau; Item Number: 15-0027/12; | Waldemar Link GmbH & Co. KG | KRO | |
| Z-1521-2026 | Class II | Endo-Model Replacement Plateau; Item Number: 15-0027/11; | Waldemar Link GmbH & Co. KG | KRO | |
| Z-1520-2026 | Class II | Endo-Model Replacement Plateau; Item Number: 15-8521/15; | Waldemar Link GmbH & Co. KG | KRO | |
| Z-1519-2026 | Class II | Endo-Model Replacement Plateau; Item Number: 15-8521/11; | Waldemar Link GmbH & Co. KG | KRO | |
| Z-1518-2026 | Class II | Endo-Model Replacement Plateau; Item Number: 15-8521/09; | Waldemar Link GmbH & Co. KG | KRO | |
| Z-1517-2026 | Class II | Endo-Model Replacement Plateau; Item Number: 15-8030/12; | Waldemar Link GmbH & Co. KG | KRO | |
| Z-1516-2026 | Class II | Endo-Model Replacement Plateau; Item Number: 15-2836/11; | Waldemar Link GmbH & Co. KG | KRO | |
| Z-1515-2026 | Class II | Endo-Model Replacement Plateau; Item Number: 15-2835/12; | Waldemar Link GmbH & Co. KG | KRO | |
| Z-1514-2026 | Class II | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; | Waldemar Link GmbH & Co. KG | KRO | |
| Z-1513-2026 | Class II | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; | Waldemar Link GmbH & Co. KG | KRO |