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-0271-2015 | Class I | Arthroscopy Pack, Catalog number 900-1042. Used by medical staff to perform patient... | Customed, Inc | FWZ | |
| Z-0270-2015 | Class I | OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care... | Customed, Inc | OKV | |
| Z-0269-2015 | Class I | Cysto Tur Pack, Catalog number 900-080. Used by medical staff to perform patient care... | Customed, Inc | LRO | |
| Z-0268-2015 | Class I | Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to perform patient... | Customed, Inc | LRO | |
| Z-0267-2015 | Class I | Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform patient care... | Customed, Inc | FDE | |
| Z-0266-2015 | Class I | O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care... | Customed, Inc | OKV | |
| Z-0265-2015 | Class I | Angiodrape Pack, Catalog number 900-002. Used by medical staff to perform patient care... | Customed, Inc | OEQ | |
| Z-0217-2015 | Class II | Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed... | Edwards Lifesciences LLC | DWF | |
| Z-0191-2015 | Class II | Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | |
| Z-0264-2015 | Class I | Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to... | Customed, Inc | FYA | |
| Z-0263-2015 | Class I | Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to... | Customed, Inc | FYA | |
| Z-0262-2015 | Class I | Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff to perform... | Customed, Inc | FYA | |
| Z-0261-2015 | Class I | Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical staff to... | Customed, Inc | FYA | |
| Z-0260-2015 | Class I | Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff... | Customed, Inc | FYA | |
| Z-0259-2015 | Class I | Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical staff to... | Customed, Inc | FYA | |
| Z-0258-2015 | Class I | Wound Management Tray, Catalog number 900-1903. Used by medical staff to perform patient... | Customed, Inc | LRO | |
| Z-0257-2015 | Class I | Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform... | Customed, Inc | LRO | |
| Z-0256-2015 | Class I | Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to perform patient... | Customed, Inc | LRO | |
| Z-0255-2015 | Class I | Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient... | Customed, Inc | FYA | |
| Z-0254-2015 | Class I | Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by medical staff to... | Customed, Inc | LLK | |
| Z-0253-2015 | Class I | Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to... | Customed, Inc | LRO | |
| Z-0252-2015 | Class I | Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform... | Customed, Inc | LRO | |
| Z-0251-2015 | Class I | Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient... | Customed, Inc | LRO | |
| Z-0250-2015 | Class I | Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient... | Customed, Inc | GDT | |
| Z-0249-2015 | Class I | Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform... | Customed, Inc | LRO | |
| Z-0248-2015 | Class I | Utility Drape End Product, Catalog number 900-582. Used by medical staff to perform... | Customed, Inc | KKX | |
| Z-0247-2015 | Class I | Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform... | Customed, Inc | MCY | |
| Z-0246-2015 | Class I | Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical staff to... | Customed, Inc | FYA | |
| Z-0245-2015 | Class I | Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform... | Customed, Inc | FYA | |
| Z-0244-2015 | Class I | Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform... | Customed, Inc | NWO | |
| Z-0243-2015 | Class I | Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient... | Customed, Inc | BSY | |
| Z-0242-2015 | Class I | Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient... | Customed, Inc | NXA | |
| Z-0241-2015 | Class I | Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perform patient... | Customed, Inc | MCY | |
| Z-0240-2015 | Class I | Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient... | Customed, Inc | MCY | |
| Z-0239-2015 | Class I | Universal Drainage Tray, Catalog number 900-032. Used by medical staff to perform... | Customed, Inc | LRO | |
| Z-0238-2015 | Class I | Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical staff to... | Customed, Inc | EYN | |
| Z-0237-2015 | Class I | Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient... | Customed, Inc | MCZ | |
| Z-0106-2015 | Class II | Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch... | AD-Tech Medical Instrument Corp. | GZL | |
| Z-0173-2015 | Class II | Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic... | Stryker Corp. | HWE | |
| Z-0172-2015 | Class II | Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic... | Stryker Corp. | HWE | |
| Z-0110-2015 | Class II | Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are... | Mortara Instrument, Inc. | MHX | |
| Z-0830-2015 | Class II | RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument... | Mako Surgical Corp. | OLO | |
| Z-0829-2015 | Class II | RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument... | Mako Surgical Corp. | OLO | |
| Z-0828-2015 | Class II | RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for... | Mako Surgical Corp. | OLO | |
| Z-0163-2015 | Class II | Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a... | C.R. Bard Inc | FFL | |
| Z-0123-2015 | Class II | The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended... | Zimmer GmbH | JWH | |
| Z-0714-2022 | Class II | KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack)... | Microbiologics, Inc. | JTR | |
| Z-0713-2022 | Class II | LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus... | Microbiologics, Inc. | JTR | |
| Z-0712-2022 | Class II | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack... | Microbiologics, Inc. | JTR | |
| Z-0714-2020 | Class II | Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually... | Alliance Tech Medical, Inc | CAH |