April 10, 2024Medical DevicesFDA
Agfa N.V. recalls Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, gene
Hazard: Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
April 10, 2024Medical DevicesFDA
O&M HALYARD, INC. recalls HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Hazard: Product was mislabeled as a Surgical Cap at its dispenser level.
April 10, 2024Medical DevicesFDA
Technicality Inc. recalls Trumpet, Needle Guide, Cat# TMS-200
Hazard: The Ring on the Trump Needle Guide can detach when excessive pressure is applied.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Hazard: The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory
April 10, 2024Medical DevicesFDA
Covidien, LP recalls Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Hazard: Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
April 10, 2024Medical DevicesFDA
Covidien, LP recalls Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Hazard: Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
April 10, 2024Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacemen
Hazard: Product incorrectly labelled.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) ST
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 R
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion STERILE #16 RUBBER BAND, Product Code EB16
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Prod
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDE
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KEL
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAM
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEM
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEED
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKI
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNEL
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
April 10, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
Hazard: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.