Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIBAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIBAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIBAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIBAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIBAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIBAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIBAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- 2022-11-09FDA-DeviceBelmont Instrument CorporationClass IICritiCool, thermoregulation device
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.
- 2022-11-09FDA-DeviceBoston Scientific CorporationClass IIEMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
- 2022-11-09FDA-DeviceBoston Scientific CorporationClass IIEMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
- 2022-11-09FDA-DeviceEthicon, Inc.Class IISTRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
- 2022-11-09FDA-DeviceBoston Scientific CorporationClass IIEKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
- 2022-11-09FDA-DeviceSenTec AGClass IIsentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
Weak skin adhesion.
- 2022-11-09FDA-DeviceEdwards Lifesciences, LLCClass IIFogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
- 2022-11-09FDA-DeviceEdwards Lifesciences, LLCClass IIFogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
- 2022-11-09FDA-DeviceBaxter Healthcare CorporationClass IHillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
- 2022-11-09FDA-DeviceBaxter Healthcare CorporationClass IHillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
- 2022-11-09FDA-DeviceBaxter Healthcare CorporationClass IHillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
- 2022-11-09FDA-DeviceBaxter Healthcare CorporationClass IHillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
- 2022-11-09FDA-DeviceBaxter Healthcare CorporationClass IHillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, P7900B100195, P7900B100230, P7900B100236, P7900B100239, P7900B100244, P7900B100256, P7900B100257, P7900B100259, P7900B100264, P7900B100268, P7900B100269, P7900B100292, P7900B100296, P7900B100302, P7900B100303, P7900B100304, P7900B100305, P7900B100312, P7900B100316, P7900B100318, P7900B100335, P7900B100341, P7900B100342, P7900B100354, P7900B100361, P7900B100368, P7900B100372, P7
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
- 2022-11-02FDA-DeviceWright Medical Technology, Inc.Class IIStryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
The tibial tray lock detail is oversized (larger than specification).
- 2022-11-02FDA-DeviceWright Medical Technology, Inc.Class IIStryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
The tibial tray lock detail is oversized (larger than specification).
- 2022-11-02FDA-DeviceMerit Medical Systems, Inc.Class IICorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.
- 2022-11-02FDA-DeviceMerit Medical Systems, Inc.Class IICorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015/A, CORA2015/B, CORA2015S/A, CORA2020/A, CORA2020/B, CORCA1410/A, CORCA1410/B, CORCA1415/A, CORCA1415/B, CORCA1610/A, CORCA1610/B, CORCA1610S/B, CORCA1615/A, CORCA1615/B, CORCA1615S/B, CORCA1810B/A, CORCA1810B/B, CORCA18
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.
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