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-1043-2019 | Class II | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial... | Smith & Nephew, Inc. | JWH | |
| Z-1042-2019 | Class II | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial... | Smith & Nephew, Inc. | JWH | |
| Z-0576-2020 | Class II | Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm... | Spectranetics Corp. | NWX | |
| Z-1236-2019 | Class II | Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462 | Siemens Healthcare Diagnostics Inc. | JZO | |
| Z-1235-2019 | Class II | Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461 | Siemens Healthcare Diagnostics Inc. | JZO | |
| Z-1234-2019 | Class II | SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399 | Siemens Healthcare Diagnostics Inc. | JZO | |
| Z-1233-2019 | Class II | Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398 | Siemens Healthcare Diagnostics Inc. | JZO | |
| Z-0733-2019 | Class II | LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-0696-2019 | Class II | PROXIMATE PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE PPH... | Ethicon Endo-Surgery Inc | GDW | |
| Z-0695-2019 | Class II | PROXIMATE HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE... | Ethicon Endo-Surgery Inc | GDW | |
| Z-0707-2020 | Class II | Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF... | Medtronic Navigation, Inc | OLO | |
| Z-0680-2020 | Class II | VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used... | Carl Zeiss Meditec Inc | OTL | |
| Z-1115-2019 | Class II | Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product... | Vygon U.S.A. | FPA | |
| Z-1114-2019 | Class II | Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product... | Vygon U.S.A. | FPA | |
| Z-0800-2019 | Class II | BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection... | C.R. Bard Inc | MJC | |
| Z-0685-2019 | Class II | I-View Contrast Enhanced Digital Mammography, ASY-08109 | Hologic, Inc. | MUE | |
| Z-1078-2019 | Class II | UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1077-2019 | Class II | The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0958-2019 | Class II | Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are... | Exactech, Inc. | PHX | |
| Z-2061-2019 | Class III | Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100 | Medela AG | FMF | |
| Z-2139-2019 | Class II | Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in... | Sage Products LLC | NSB | |
| Z-1394-2022 | Class III | Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 | Stryker Corp. | FQA | |
| Z-1105-2020 | Class II | Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI... | Intuitive Surgical, Inc. | NAY | |
| Z-0692-2019 | Class II | DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling... | AGFA Healthcare Corp. | KPR | |
| Z-0729-2019 | Class II | BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile... | Waldemar Link GmbH & Co. KG | MEH | |
| Z-0728-2019 | Class II | BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile... | Waldemar Link GmbH & Co. KG | MEH | |
| Z-0840-2019 | Class II | Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo... | Randox Laboratories, Limited | CJY | |
| Z-0839-2019 | Class II | Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent... | Randox Laboratories, Limited | CJY | |
| Z-0686-2019 | Class II | MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information... | Elekta Limited | IYE | |
| Z-1327-2019 | Class II | Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile... | PENTAX of America, Inc. | GEH | |
| Z-1326-2019 | Class II | Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product... | PENTAX of America, Inc. | GEH | |
| Z-1325-2019 | Class II | Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile... | PENTAX of America, Inc. | GEH | |
| Z-1108-2019 | Class II | iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102... | ConforMIS, Inc. | JWH | |
| Z-0694-2019 | Class II | Ingenia Elition S, Ingenia Elition X | Philips Medical Systems Nederland B.V. | LNH | |
| Z-1018-2019 | Class II | Fructosamine Control 3, FR2996 This product is intended for in vitro use in the... | Randox Laboratories, Limited | JJX | |
| Z-1017-2019 | Class II | Fructosamine Control 1, FR2994 This product is intended for in vitro use in the... | Randox Laboratories, Limited | JJX | |
| Z-1016-2019 | Class II | Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the... | Randox Laboratories, Limited | JIT | |
| Z-0970-2019 | Class II | C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2... | PENTAX of America, Inc. | GEH | |
| Z-0725-2019 | Class II | MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and... | Canadian Hospital Specialties Ltd. | FPD | |
| Z-2259-2020 | Class II | System, Tomography Computed Emmission | GE Healthcare | KPS | |
| Z-2258-2020 | Class II | System, Tomography Computed Emmission | GE Healthcare | KPS | |
| Z-1997-2019 | Class II | Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 | Philips Medical Systems Nederland B.V. | OWB | |
| Z-0707-2019 | Class II | Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1066-2019 | Class II | BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula... | Becton Dickinson & Co | HMX | |
| Z-0676-2019 | Class II | ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC... | Tosoh Bioscience Inc | CKG | |
| Z-0675-2019 | Class II | ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the... | Tosoh Bioscience Inc | LPS | |
| Z-0674-2019 | Class II | ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the... | Tosoh Bioscience Inc | CDZ | |
| Z-0673-2019 | Class II | ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY... | Tosoh Bioscience Inc | CDP | |
| Z-0672-2019 | Class II | AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative... | Tosoh Bioscience Inc | CGN | |
| Z-0671-2019 | Class II | AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the... | Tosoh Bioscience Inc | CDD |