Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-02-12FDA-DeviceRandox Laboratories Ltd.Class IIILiquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).
- 2020-02-12FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IITelescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
- 2020-02-12FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IITelescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
- 2020-02-12FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IISafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
- 2020-02-12FDA-DeviceMicrobiologics IncClass IIVaginal Verification Panel Ref 8208 Lot 8208-11
Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK P429589A TRAY BONE MARRO ASC LTX SAFE P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758486 PVP PREP PACK P758486 PVP PREP PACK P922260 ALCOHOL PREP PACK P928310 WET PREP TRAY P928310 WET PREP TRAY P948416 LACERATION PACK P966455A BREAST BIOPSY PACK-LF
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280 UMBILICAL ARTERY TRAY UVT460 UMBILICAL CATHETER TRAY UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH UVT630 UMBILICAL/PICC/CHEST TUBE INS KIT UVT640 UMBILICAL CATHETER INSERTION TRAY (P/S) UVT665 UMBILICAL VESSEL CATHETER TRAY UVT730 UMBILICAL VESSEL INSERTION TRAY UVT795 UMBILICAL CATH TRAY UVT960A UMBILICAL PICC/INSERTION TRAY UVT960A U
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- PT225 PAIN MANAGEMENT TRAY
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- ENT SNUF3 SNUFFER KIT Y
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- OR2020 BASIN SET
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101413 ADULT LUMBAR PUMP W NDLS MANO M101472A PREP PACK
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- LC145 STERILE NICU LINE CHANGE KIT
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- Port Draw Kit KNV30 PORT DRAW KIT
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion IVS3505 ULTRASOUND GUIDED PIV KIT
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN)
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- I86625 DEBRIDEMENT TRAY
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Suture Tray DYNDR1210A SUTURING TRAY
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Skin Prep Tray DYNDP1015 SKIN PREP TRAY
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT DM380 DAILY LVAD KIT MORRISTOWN MEDICAL DM405A ADVOCATE CHRIST DAILY WET KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT DM545 U OF U LVAD SENSITIVE SKIN DRESSING SYST DM550 VAD DRIVELINE MANAGEMENT TRAY DM555 LVAD MULTI-DAY DRIVELINE MGMT SIZE M/L DM565 LVAD DRESSING SYSTEM DM575 LVAD MULTI-DAY DRIVELINE MGMT SIZE S DM610 DRIVELINE MANAGE
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
Incomplete seals on the sterile package may compromise the sterility
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