Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Potential for detachment of a distal tip component of the device during use.
FDA DrugsFRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Lack of Assurance of Sterility
FDA FoodBombay Kitchen brand Tikka Sev; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canola Oil, Spices, Salt, FD&C Tomato Color and Citric Acid; CAUTION: May Contain Traces of Peanuts, Cashews and/or Tree Nuts; Manufactured by Bombay Kitchen Foods Port Washington, NY 11050
Bombay Kitchen brand Tikka Sev; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canola Oil, Spices, Salt, FD&C Tomato Color and Citric Acid; CAUTION: May Contain Traces of Peanuts, Cashews and/or Tree Nuts; Manufactured by Bombay Kitchen Foods Port Washington, NY 11050
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
FDA DevicesLSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
FDA DevicesOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
FDA DevicesSoft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (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.
RappelConsorenault trucks - master iv véhicule utilitaire léger
renault trucks - master iv véhicule utilitaire léger
en raison d'une défaillance de fabrication, la force de rupture sur l'arrêt de la pédale d'accélérateur peut être défectueuse. en conséquence, la force de rupture sur l'arrêt de la pédale d'accélérateur est inférieure à la valeur prescrite dans les spécifications techniques, ce qui pourrait entraîner une perte de contrôle du conducteur et provoquer un accident.
RappelConsofiestas guirca - cost. fille pirate blanche t-5/6ans + t. 7/9 ans + t. 10/12 ans
fiestas guirca - cost. fille pirate blanche t-5/6ans + t. 7/9 ans + t. 10/12 ans
présence sur le chapeau d'une plume très inflammable
FDA DrugsLACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
UKMHRA Safety Roundup: April 2026
MHRA Safety Roundup: April 2026
Summary of the latest safety advice for medicines and medical device users...
FDA DevicesARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 REF ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 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.
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 REF ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 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
NHTSANewmar Corporation - Incorrect Cargo Carrying Capacity on Label/FMVSS 120
Newmar Corporation - Incorrect Cargo Carrying Capacity on Label/FMVSS 120
Incorrect weight information can allow the vehicle to be overloaded, increasing the risk of a crash.
FDA DevicesSoft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (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.
FDA DevicesCUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Software issue that renders the touch screen unresponsive.
NHTSADorman Products, Inc. - Detached Shift Cable Bushing/FMVSS 102, 114
Dorman Products, Inc. - Detached Shift Cable Bushing/FMVSS 102, 114
The inability to shift into "Park" can result in a vehicle rollaway, increasing the risk of a crash.
FDA DevicesMedline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
FDA DevicesARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 REF ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 REF ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
FDA DevicesMedline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
FDA DrugsOmega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
FDA DevicesCustom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
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).
FDA DevicesPERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
FDA DevicesAccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch); Box Quantity: 5 pouches;
AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (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.
FDA DevicesLSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
NHTSARoadtrek Inc. - Pop-Top Latch and Safety Straps May Fail
Roadtrek Inc. - Pop-Top Latch and Safety Straps May Fail
A pop-top that lifts during transit can distract the driver, or detach if the secondary safety straps fail, increasing the risk of a crash.