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-0541-2023 | Class II | STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583, | Gyn-Disposables, Inc. | OEZ | |
| Z-0540-2023 | Class II | STRADIS HEALTHCARE, Phleb, Item No.682-1425, | Gyn-Disposables, Inc. | OEZ | |
| Z-0539-2023 | Class II | STRADIS HEALTHCARE, Ablation Pack, Item No.682-130, | Gyn-Disposables, Inc. | OEZ | |
| Z-0538-2023 | Class II | STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228, | Gyn-Disposables, Inc. | FTN | |
| Z-0537-2023 | Class II | STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001, | Gyn-Disposables, Inc. | OEZ | |
| Z-0536-2023 | Class II | STRADIS HEALTHCARE, Lipo, Item No.681-254, | Gyn-Disposables, Inc. | FTN | |
| Z-0535-2023 | Class II | STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS, | Gyn-Disposables, Inc. | EIC | |
| Z-0534-2023 | Class II | HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131 | Gyn-Disposables, Inc. | OEZ | |
| Z-0533-2023 | Class II | HENRY SCHEIN, Labiaplasty PackItem No.570-3118, | Gyn-Disposables, Inc. | LRO | |
| Z-0532-2023 | Class II | HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092 | Gyn-Disposables, Inc. | PXO | |
| Z-0531-2023 | Class II | HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091, | Gyn-Disposables, Inc. | PXO | |
| Z-0530-2023 | Class II | HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089 | Gyn-Disposables, Inc. | OGE | |
| Z-0529-2023 | Class II | HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072 | Gyn-Disposables, Inc. | LRO | |
| Z-0528-2023 | Class II | HENRY SCHEIN, RHINO PACK, Item No.570-3070 | Gyn-Disposables, Inc. | FTN | |
| Z-0527-2023 | Class II | HENRY SCHEIN, Amnio Tray, Item No.570-3059, | Gyn-Disposables, Inc. | HIO | |
| Z-0526-2023 | Class II | HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946 | Gyn-Disposables, Inc. | OJH | |
| Z-0525-2023 | Class II | HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930 | Gyn-Disposables, Inc. | OEQ | |
| Z-0524-2023 | Class II | HENRY SCHEIN, Knee Pack, Item No.570-2908, | Gyn-Disposables, Inc. | OJH | |
| Z-0523-2023 | Class II | HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900, | Gyn-Disposables, Inc. | LRO | |
| Z-0522-2023 | Class II | HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891 | Gyn-Disposables, Inc. | OEZ | |
| Z-0521-2023 | Class II | HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890 | Gyn-Disposables, Inc. | LRO | |
| Z-0520-2023 | Class II | HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883 | Gyn-Disposables, Inc. | LRO | |
| Z-0519-2023 | Class II | HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793 | Gyn-Disposables, Inc. | LRO | |
| Z-0518-2023 | Class II | HENRY SCHEIN, CATH PACK Item No.570-2789 | Gyn-Disposables, Inc. | OEZ | |
| Z-0517-2023 | Class II | HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787 | Gyn-Disposables, Inc. | LRO | |
| Z-0516-2023 | Class II | HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783, | Gyn-Disposables, Inc. | OJH | |
| Z-0515-2023 | Class II | HENRY SCHEIN, OMFS, Item No.570-2779, | Gyn-Disposables, Inc. | OFX | |
| Z-0514-2023 | Class II | HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742 | Gyn-Disposables, Inc. | OGR | |
| Z-0513-2023 | Class II | HENRY SCHEIN, VEIN TRAY, Item No.570-2738, | Gyn-Disposables, Inc. | OEZ | |
| Z-0512-2023 | Class II | HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI... | Gyn-Disposables, Inc. | LRO | |
| Z-0511-2023 | Class II | HENRY SCHEIN, ENT PACK, Item No.570-2718 | Gyn-Disposables, Inc. | PWL | |
| Z-0510-2023 | Class II | HENRY SCHEIN, GYN PACK, Item No.570-2625 | Gyn-Disposables, Inc. | PVX | |
| Z-0509-2023 | Class II | HENRY SCHEIN, BREAST PACK, Item No.570-2397 | Gyn-Disposables, Inc. | FTN | |
| Z-0508-2023 | Class II | HENRY SCHEIN, Basin Set, Item No.570-1803 | Gyn-Disposables, Inc. | LRO | |
| Z-0507-2023 | Class II | HENRY SCHEIN, Basin Pack, Item No.570-1692 | Gyn-Disposables, Inc. | LRO | |
| Z-0506-2023 | Class II | HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray | Gyn-Disposables, Inc. | LRO | |
| Z-0505-2023 | Class II | HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482 | Gyn-Disposables, Inc. | PKE | |
| Z-0504-2023 | Class II | HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray | Gyn-Disposables, Inc. | LRO | |
| Z-0503-2023 | Class II | HENRY SCHEIN, Vein Clinics 1, Item No.570-1426 | Gyn-Disposables, Inc. | OEZ | |
| Z-0502-2023 | Class II | HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611 | Gyn-Disposables, Inc. | FTN | |
| Z-0501-2023 | Class II | STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray | Gyn-Disposables, Inc. | LRO | |
| Z-0500-2023 | Class II | STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular | Gyn-Disposables, Inc. | OFL | |
| Z-0499-2023 | Class II | STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001 | Gyn-Disposables, Inc. | LRO | |
| Z-0498-2023 | Class II | STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010, | Gyn-Disposables, Inc. | KXG | |
| Z-0497-2023 | Class II | Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP | Gyn-Disposables, Inc. | PWL | |
| Z-0496-2023 | Class II | STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental | Gyn-Disposables, Inc. | PWL | |
| Z-0495-2023 | Class II | STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS, | Gyn-Disposables, Inc. | PWL | |
| Z-0494-2023 | Class II | Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray | Gyn-Disposables, Inc. | NYD | |
| Z-0493-2023 | Class II | STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray | Gyn-Disposables, Inc. | OFX | |
| Z-0492-2023 | Class II | Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray | Gyn-Disposables, Inc. | PWL |