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-0589-2023 | Class II | DeRoyal LAPINECTOMY PACK, REF 89-7198.11 | DeRoyal Industries, Inc. | LRO | |
| Z-0588-2023 | Class II | DeRoyal LAPINECTOMY PACK, REF 89-7198.10 | DeRoyal Industries, Inc. | LRO | |
| Z-0587-2023 | Class II | DeRoyal TRANS CANAL PACK, REF 89-7157.12 | DeRoyal Industries, Inc. | LRO | |
| Z-0586-2023 | Class II | DeRoyal CATARACT PACK, REF 89-7135.10 | DeRoyal Industries, Inc. | LRO | |
| Z-0585-2023 | Class II | DeRoyal GU ROBOTIC PACK, REF 89-7063.12 | DeRoyal Industries, Inc. | LRO | |
| Z-0584-2023 | Class II | DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11 | DeRoyal Industries, Inc. | LRO | |
| Z-0583-2023 | Class II | DeRoyal BREAST TRAY, REF 89-7033.07 | DeRoyal Industries, Inc. | LRO | |
| Z-0582-2023 | Class II | DeRoyal CANNULTED HIP PACK, REF 89-6977.10 | DeRoyal Industries, Inc. | LRO | |
| Z-0581-2023 | Class II | DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09 | DeRoyal Industries, Inc. | LRO | |
| Z-0580-2023 | Class II | DeRoyal CATARACT PACK CSM, REF 89-6863 | DeRoyal Industries, Inc. | LRO | |
| Z-0579-2023 | Class II | DeRoyal SHOULDER PACK, REF 89-6830.13 | DeRoyal Industries, Inc. | LRO | |
| Z-0578-2023 | Class II | Geo-Med Total Knee Pack a & B, Ref 89-6799.02 | DeRoyal Industries, Inc. | LRO | |
| Z-0577-2023 | Class II | Geo-Med Plastic Hand Pack RF, Ref 89-6667.10 | DeRoyal Industries, Inc. | LRO | |
| Z-0576-2023 | Class II | Geo-Med Plastic Hand Pack RF, Ref 89-6667.09 | DeRoyal Industries, Inc. | LRO | |
| Z-0575-2023 | Class II | DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09 | DeRoyal Industries, Inc. | LRO | |
| Z-0574-2023 | Class II | DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07 | DeRoyal Industries, Inc. | LRO | |
| Z-0573-2023 | Class II | DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09 | DeRoyal Industries, Inc. | LRO | |
| Z-0572-2023 | Class II | Geo-Med Opthalmology Cstm Pck, Ref 89-6387.09 | DeRoyal Industries, Inc. | LRO | |
| Z-0571-2023 | Class II | Geo-Med Opthalmology Cstm Pck, Ref 89-6387.08 | DeRoyal Industries, Inc. | LRO | |
| Z-0570-2023 | Class II | Geo-Med Podiatry Pack Pgybk, Ref 89-6240.05 | DeRoyal Industries, Inc. | LRO | |
| Z-0569-2023 | Class II | DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13 | DeRoyal Industries, Inc. | LRO | |
| Z-0568-2023 | Class II | Geo-Med Shoulder Arthroscopy Knee Pack, Ref 89-5797.09 | DeRoyal Industries, Inc. | LRO | |
| Z-0567-2023 | Class II | Geo-Med Total Knee Pack a & B Pgyk, Ref 89-5796.13 | DeRoyal Industries, Inc. | LRO | |
| Z-0566-2023 | Class II | Geo-Med Knee Arthroscopy Pack, Ref 89-5795.07 | DeRoyal Industries, Inc. | LRO | |
| Z-0565-2023 | Class II | DeRoyal PEDI ORTHO PACK, REF 89-5323.20 | DeRoyal Industries, Inc. | LRO | |
| Z-0564-2023 | Class II | DeRoyal EYE TRAY, REF 89-4957.08 | DeRoyal Industries, Inc. | LRO | |
| Z-0563-2023 | Class II | DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07 | DeRoyal Industries, Inc. | LRO | |
| Z-0562-2023 | Class II | DeRoyal EYE PACK, REF 89-4051.09 | DeRoyal Industries, Inc. | LRO | |
| Z-0561-2023 | Class II | DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15 | DeRoyal Industries, Inc. | LRO | |
| Z-0560-2023 | Class II | DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15 | DeRoyal Industries, Inc. | LRO | |
| Z-1022-2023 | Class II | SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial... | SynCardia Systems LLC | LOZ | |
| Z-0465-2023 | Class II | Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S... | Arthrex GmbH | MDM | |
| Z-0425-2023 | Class II | The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and... | Qvella Corporation | JJH | |
| Z-0558-2023 | Class II | STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225, | Gyn-Disposables, Inc. | EHZ | |
| Z-0557-2023 | Class II | HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549, | Gyn-Disposables, Inc. | PVY | |
| Z-0556-2023 | Class II | HENRY SCHEIN, Vas Pack, Item No.888-2520, | Gyn-Disposables, Inc. | LRO | |
| Z-0555-2023 | Class II | STRADIS HEALTHCARE, Breast, Item No.693-276, | Gyn-Disposables, Inc. | FTN | |
| Z-0554-2023 | Class II | STRADIS HEALTHCARE, Angio Pack, Item No.686-199, | Gyn-Disposables, Inc. | OEQ | |
| Z-0553-2023 | Class II | STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142, | Gyn-Disposables, Inc. | OEQ | |
| Z-0552-2023 | Class II | STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947, | Gyn-Disposables, Inc. | OEZ | |
| Z-0551-2023 | Class II | STRADIS HEALTHCARE, Vein, Item No.682-577, | Gyn-Disposables, Inc. | OEZ | |
| Z-0550-2023 | Class II | STRADIS HEALTHCARE, Endo Pack, Item No.682-509, | Gyn-Disposables, Inc. | OEZ | |
| Z-0549-2023 | Class II | www.StradisHealthcare.com, Endovenous Pack, Item No.682-494, | Gyn-Disposables, Inc. | OEZ | |
| Z-0548-2023 | Class II | STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1, | Gyn-Disposables, Inc. | OEZ | |
| Z-0547-2023 | Class II | STRADIS HEALTHCARE, Medical Vein, Item No.682-330, | Gyn-Disposables, Inc. | OEZ | |
| Z-0546-2023 | Class II | STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1, | Gyn-Disposables, Inc. | LRO | |
| Z-0545-2023 | Class II | STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1, | Gyn-Disposables, Inc. | OEZ | |
| Z-0544-2023 | Class II | STRADIS HEALTHCARE, Angioplasty, Item No.682-1937, | Gyn-Disposables, Inc. | OEQ | |
| Z-0543-2023 | Class II | STRADIS HEALTHCARE, Vein, Item No.682-1732, | Gyn-Disposables, Inc. | OEZ | |
| Z-0542-2023 | Class II | STRADIS HEALTHCARE, Surgery PK, Item No.682-1728, | Gyn-Disposables, Inc. | OEZ |