Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied
Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Potential for detachment of a distal tip component of the device during use.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
Unapproved design changes to the products outside of the 510(k) clearance.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
Unapproved design changes to the products outside of the 510(k) clearance.
Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6) SYRINGE 8ML CONTROL MLL, Model Number: DYNJSYR8C; 7) SYRINGE 12ML CONTROL MLL, Model Number: DYNJSYR12C; 8) SYR CONTROL PAD 10ML L/L ROT, Model Number: DYNJSYR10CRP; 9) SYR CONTROL PAD 12ML L/L ROT, Model Number: DYNJSYR12CRP; 10) CTRL SYRINGE 6ML RING ROT L/L, Model Number: DYNJSYRC6CWR
Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6) SYRINGE 8ML CONTROL MLL, Model Number: DYNJSYR8C; 7) SYRINGE 12ML CONTROL MLL, Model Number: DYNJSYR12C; 8) SYR CONTROL PAD 10ML L/L ROT, Model Number: DYNJSYR10CRP; 9) SYR CONTROL PAD 12ML L/L ROT, Model Number: DYNJSYR12CRP; 10) CTRL SYRINGE 6ML RING ROT L/L, Model Number: DYNJSYRC6CWR
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
Storyteller Overland - Improperly Routed Coolant Lines May Cause a Loss of Drive Power
Storyteller Overland - Improperly Routed Coolant Lines May Cause a Loss of Drive Power
A loss of drive power increases the risk of a crash.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ69200A DYNJ88276 ANGIO PHC DYNJ37485D ANGIO TRAY 116118 DYNJ37724K ANGIO TRAY NO LIDO DYNJ85557 DYNJ85557B ANGIOGRAM-30852 DYNJVB91148A ANGIOGRAPHY DRAPE PACK-LF DYNJ0373221P ANGIOGRAPHY PACK DYNJ17218R DYNJ44293F DYNJ44293G DYNJ44293J DYNJ83516 ANGIOGRAPHY PACK-LF DYNJ0854485X ARTERIOGRAM DYNJ28082I BASIC HEART CATH PACK DYNJVB1075B CARDIAC CATH DYNJ910293 CARDIAC CATH PACK DYNJ68653B DYNJ68653C CARDIAC CATH PACK-LF DYNJ85258 CATH LAB (EP) PACK DYNJ65162B CATH LAB ANGIO PACK-LF DYNJ0545064AA CATH LAB ANGIO TRAY DYNJ83506A CATH LAB PACK DYNJ66366D DYNJ66366F DYNJT2202U CATH LAB PROCEDURE PK DYNJ57723C CATH LAB TRAY DYNJ37389P DYNJ37389Q CATH PACK DYNJ62595C DYNJ62595D DYNJ69997A HEART CATH PACK DYNJ85783 HEART CATH-SFMC DYNJ82434 INTERVENTIONAL PACK DYNJ56666D INTERVENTIONAL PACK-LF DYNJ37211J INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AI IR PACK DYNJ36752B JUDKINS PACK DYNJ51126C M&E ANGIOGRAPHY PK DYNJ83812 NEURO ANGIO PACK DYNJ51697C NEUROLOGICAL CATH PACK DYNJ63434D OR HYBRID-MRMC DYNJ907758C PTCA PACK DYNJ55359C DYNJ55359D RADIOLOGY ANGIO MAJOR PACK DYNJ62858C SURGERY ANGIO PACK-LF PHS677784013B ANGIO ARTERIOGRAM PACK-LF DYNJ0774026J ANGIO IR PACK DYNJ31196G ANGIO PACK DYNJ30565F, DYNJ69200 ANGIOGRAM PACK-LF DYNJ21574K, DYNJ21574L ANGIOGRAPHY PACK DYNJ26855G, DYNJ26855I BGMC CARDIAC CATH PACK-LF DYNJ0664960D CARDIAC CATH DYNJ59898B CARDIAC CATH PACK DYNJ68653A, DYNJ69150A CATH LAB ANGIO PACK-LF DYNJ0545064Y CATH LAB PACK DYNJ28428F, DYNJ80457 CATH LAB-LF DYNJ51423F CATH PACK DYNJ62595B, DYNJ62983A CATH PROCEDURAL TRAY DYNJ43580D GENERAL ANGIO PACK DYNJ57760C HEART CATH PACK DYNJ69318 HEART CATH TRAY DYNJ53251J, DYNJ81557 IR PACK DYNJ65312 MAIN OR CATH LAB DYNJ61373A M CARDIAC CATH DYNJ58339A N CATH PACK NG140A OR RADIOLOGY PACK DYNJ62747 RADIOLOGY PACK DYNJ42633C R ANGIO PACK DYNJ36338C SPECIAL TRAY DYNJ65756A TAVR PACK DYNJ69246
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ69200A DYNJ88276 ANGIO PHC DYNJ37485D ANGIO TRAY 116118 DYNJ37724K ANGIO TRAY NO LIDO DYNJ85557 DYNJ85557B ANGIOGRAM-30852 DYNJVB91148A ANGIOGRAPHY DRAPE PACK-LF DYNJ0373221P ANGIOGRAPHY PACK DYNJ17218R DYNJ44293F DYNJ44293G DYNJ44293J DYNJ83516 ANGIOGRAPHY PACK-LF DYNJ0854485X ARTERIOGRAM DYNJ28082I BASIC HEART CATH PACK DYNJVB1075B CARDIAC CATH DYNJ910293 CARDIAC CATH PACK DYNJ68653B DYNJ68653C CARDIAC CATH PACK-LF DYNJ85258 CATH LAB (EP) PACK DYNJ65162B CATH LAB ANGIO PACK-LF DYNJ0545064AA CATH LAB ANGIO TRAY DYNJ83506A CATH LAB PACK DYNJ66366D DYNJ66366F DYNJT2202U CATH LAB PROCEDURE PK DYNJ57723C CATH LAB TRAY DYNJ37389P DYNJ37389Q CATH PACK DYNJ62595C DYNJ62595D DYNJ69997A HEART CATH PACK DYNJ85783 HEART CATH-SFMC DYNJ82434 INTERVENTIONAL PACK DYNJ56666D INTERVENTIONAL PACK-LF DYNJ37211J INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AI IR PACK DYNJ36752B JUDKINS PACK DYNJ51126C M&E ANGIOGRAPHY PK DYNJ83812 NEURO ANGIO PACK DYNJ51697C NEUROLOGICAL CATH PACK DYNJ63434D OR HYBRID-MRMC DYNJ907758C PTCA PACK DYNJ55359C DYNJ55359D RADIOLOGY ANGIO MAJOR PACK DYNJ62858C SURGERY ANGIO PACK-LF PHS677784013B ANGIO ARTERIOGRAM PACK-LF DYNJ0774026J ANGIO IR PACK DYNJ31196G ANGIO PACK DYNJ30565F, DYNJ69200 ANGIOGRAM PACK-LF DYNJ21574K, DYNJ21574L ANGIOGRAPHY PACK DYNJ26855G, DYNJ26855I BGMC CARDIAC CATH PACK-LF DYNJ0664960D CARDIAC CATH DYNJ59898B CARDIAC CATH PACK DYNJ68653A, DYNJ69150A CATH LAB ANGIO PACK-LF DYNJ0545064Y CATH LAB PACK DYNJ28428F, DYNJ80457 CATH LAB-LF DYNJ51423F CATH PACK DYNJ62595B, DYNJ62983A CATH PROCEDURAL TRAY DYNJ43580D GENERAL ANGIO PACK DYNJ57760C HEART CATH PACK DYNJ69318 HEART CATH TRAY DYNJ53251J, DYNJ81557 IR PACK DYNJ65312 MAIN OR CATH LAB DYNJ61373A M CARDIAC CATH DYNJ58339A N CATH PACK NG140A OR RADIOLOGY PACK DYNJ62747 RADIOLOGY PACK DYNJ42633C R ANGIO PACK DYNJ36338C SPECIAL TRAY DYNJ65756A TAVR PACK DYNJ69246
Unapproved design changes to the products outside of the 510(k) clearance.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Unapproved design changes to the products outside of the 510(k) clearance.
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Transport Canada Recall - 2026210 - GRAND DESIGN RV
Transport Canada Recall - 2026210 - GRAND DESIGN RV
Structure
Transport Canada Recall - 2026202 - VOLKSWAGEN
Transport Canada Recall - 2026202 - VOLKSWAGEN
Fuel System
SALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 69203 01617 0
SALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 69203 01617 0
Product may be contaminated with Salmonella.
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Transport Canada Recall - 2026204 - MACK
Transport Canada Recall - 2026204 - MACK
Brakes
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Transport Canada Recall - 2026203 - VOLVO TRUCKS
Transport Canada Recall - 2026203 - VOLVO TRUCKS
Brakes