Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class IIEASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class IICEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class IIBPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class IIBPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class IIRENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class IIBPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBioseal CorporationClass IIBioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
- 2021-05-26FDA-DeviceBioseal CorporationClass IIBioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
- 2021-05-26FDA-DeviceBioseal CorporationClass IIBioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
- 2021-05-26FDA-DeviceBoston Scientific CorporationClass IIELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4.0-6.0 mm and total lesion lengths up to 190 mm.
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 00763000252045 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 00763000414375 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 00763000318895 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 20763000414362 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed w
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTIN: 20763000243368 GS3 5PK 9L OUS3/ GTIN: 20763000318882 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 20763000318868 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ GTIN: 20643169704071 GS3 5PK 9L OUS1/ GTIN: 20763000243320 GS3 5PK 9L OUS1/ GTIN: 20763000318844 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- 2021-05-26FDA-DeviceMedtronic Inc.Class IIMedtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
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