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.
- 2021-06-30FDA-DeviceAdler MicroMed, Inc.Class IISapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Pu
Due to issue with product sterility. Sterilization service provider had falsified records.
- 2021-06-30FDA-DeviceVero Biotech, LLCClass IGENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
- 2021-06-23FDA-DeviceBard Peripheral Vascular IncClass IIVENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS; VENEL14080 /Venovo 9F 14/80/1200mm OUS; VENEL14100 /Venovo 9F 14/100/1200mm OUS; VENEL14120 /Venovo 9F 14/120/1200mm OUS; VENEL14140 /Venovo 9F 14/140/1200mm OUS; VENEL14160 /Venovo 9F 14/160/1200mm OUS; VENEM14040 /Venovo 9F 14/40/800mm OUS; VENEM14060 /Venovo 9F 14/60/800mm OUS; VENEM14080 /Venovo 9F 14/80/800mm OUS; VENEM14100 /Venovo
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
- 2021-06-23FDA-DeviceBard Peripheral Vascular IncClass IIVENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/60/1200mm OUS; VENEL10080 /Venovo 8F 10/80/1200mm OUS; VENEL10100 /Venovo 8F 10/100/1200mm OUS; VENEL10120 /Venovo 8F 10/120/1200mm OUS; VENEL10140 /Venovo 8F 10/140/1200mm OUS; VENEL10160 /Venovo 8F10/160/1200mm OUS; VENEL12040 /Venovo 8F 12/40/1200mm OUS; VENEL12060 /Venovo 8F 12/60/1200mm OUS; VENEL12080 /Venovo 8F 12/80/1200mm OUS; VENEL12100 /Venov
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
- 2021-06-23FDA-DeviceBard Peripheral Vascular IncClass IIVENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200mm OUS VENEL16080 Venovo 10F 16/80/1200mm OUS VENEL16100 Venovo 10F 16/100/1200mm OUS VENEL16120 Venovo 10F 16/120/1200mm OUS VENEL16140 Venovo 10F 16/140/1200mm OUS VENEL16160 Venovo 10F 16/160/1200mm OUS VENEL18040 Venovo 10F 18/40/1200mm OUS VENEL18060 Venovo 10F 18/60/1200mm OUS VENEL18080 Venovo 10F 18/80/1200mm OUS VENEL18100 Venovo 10F 18/
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
- 2021-06-23FDA-DeviceOssur AmericasClass IIOSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical spine.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
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