Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Showing 24 of 74,116 results
Medical Device
FDA Devices
FDA DevicesRolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.
Omnicell, Inc.
FDA DevicesClass I
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.
Potential for mislabeled syringe produced by the i.v.STATION device.
May 20, 2026Omnicell, Inc.
Medical DeviceFDA Devices
FDA DevicesNextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X; NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM
ARROW INTERNATIONAL, LLC
FDA DevicesClass I
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X; NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
May 20, 2026ARROW INTERNATIONAL, LLC
PharmaceuticalFDA Drugs
FDA DrugsAscend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.
Ascend Laboratories, LLC
FDA DrugsClass II
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.
Failed Dissolution Specifications
May 20, 2026Ascend Laboratories, LLC
Medical DeviceFDA Devices
FDA DevicesBARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
FDA DevicesClass II
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
May 20, 2026Stryker Sustainability Solutions
Food & BeverageFDA Food
FDA FoodFrederik's by meijer Vanilla Bourbon Trail Mix, packed in plastic retail-sized black bag NET WT 9 OZ (255g). On the back of the bag is both lot number and a stamped expiration date. UPC 719283 357212; 12-9oz retail units per case.
Ferris Coffee and Nut Company, Inc.
FDA FoodClass II
Frederik's by meijer Vanilla Bourbon Trail Mix, packed in plastic retail-sized black bag NET WT 9 OZ (255g). On the back of the bag is both lot number and a stamped expiration date. UPC 719283 357212; 12-9oz retail units per case.
Undeclared allergens (wheat and soy).
May 20, 2026Ferris Coffee and Nut Company, Inc.
Medical DeviceFDA Devices
FDA DevicesEdwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Edwards Lifesciences, LLC
FDA DevicesClass II
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
May 20, 2026Edwards Lifesciences, LLC
Medical DeviceFDA Devices
FDA DevicesLUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
Jolife AB
FDA DevicesClass II
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).
May 20, 2026Jolife AB
Medical DeviceFDA Devices
FDA DevicesMedline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.
Medline Industries, LP
FDA DevicesClass I
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesDaig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
FDA DevicesClass II
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
May 20, 2026Stryker Sustainability Solutions
Medical DeviceFDA Devices
FDA DevicesRevolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
GE Medical Systems, LLC
FDA DevicesClass II
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
May 20, 2026GE Medical Systems, LLC
Medical DeviceFDA Devices
FDA DevicesNamic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Medline Industries, LP
FDA DevicesClass I
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesDaig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
FDA DevicesClass II
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
May 20, 2026Stryker Sustainability Solutions
Medical DeviceFDA Devices
FDA DevicesOn-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
On-X Life Technologies, Inc.
FDA DevicesClass II
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
May 20, 2026On-X Life Technologies, Inc.
Medical DeviceFDA Devices
FDA DevicesMedline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.
Medline Industries, LP
FDA DevicesClass I
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
May 20, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesArrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
ARROW INTERNATIONAL, LLC
FDA DevicesClass I
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
May 20, 2026ARROW INTERNATIONAL, LLC
Vehicle RecallNHTSA
NHTSABlue Bird Body Company - Wheelchair Restraint Retractor May Not Lock
Blue Bird Body Company
NHTSAEQUIPMENT ADAPT...
Blue Bird Body Company - Wheelchair Restraint Retractor May Not Lock
An unsecured wheelchair can move during transit, increasing the risk of injury.
May 20, 2026Blue Bird Body Company
Vehicle RecallNHTSA
NHTSAToyota Motor Engineering & Manufacturing - Debris in Engine May Cause Stall
Toyota Motor Engineering & Manufacturing
NHTSAENGINE AND ENGI...
Toyota Motor Engineering & Manufacturing - Debris in Engine May Cause Stall
A loss of drive power increases the risk of a crash.
May 20, 2026Toyota Motor Engineering & Manufacturing
Food & BeverageFDA Food
FDA Food...And Kimchi branded kimchi; packaged in 3 sizes of glass containers (126oz, 63oz, 30oz); 126oz UPC- 8541200408 62oz UPC- 8651200409 30oz UPC- 8541200411
Ocinet, Inc.
FDA FoodClass II
...And Kimchi branded kimchi; packaged in 3 sizes of glass containers (126oz, 63oz, 30oz); 126oz UPC- 8541200408 62oz UPC- 8651200409 30oz UPC- 8541200411
Undeclared allergen ingredient (fish)
May 20, 2026Ocinet, Inc.
Food & Beverage
RappelConso
RappelConsoferme la maison rouge - fromage blanc sur lit de fruit
ferme la maison rouge
RappelConsovolontaire (san...
ferme la maison rouge - fromage blanc sur lit de fruit
présence de listeria monocytogène
May 20, 2026ferme la maison rouge
Vehicle RecallNHTSA
NHTSAK.Z., Inc. - Incorrectly Tightened Shock Bolts
K.Z., Inc.
NHTSASUSPENSION
K.Z., Inc. - Incorrectly Tightened Shock Bolts
Broken shock retainer bolt heads and washers may detach and become a road hazard for other vehicles, increasing the risk of a crash.
May 20, 2026K.Z., Inc.
Vehicle RecallNHTSA
NHTSAWabash National Corporation - Missing Conspicuity Tape/FMVSS 108
Wabash National Corporation
NHTSAGeneral Alert
Wabash National Corporation - Missing Conspicuity Tape/FMVSS 108
Missing conspicuity tape can reduce the visibility of the trailer to other drivers, increasing the risk of a crash.
May 20, 2026Wabash National Corporation
Medical DeviceFDA Devices
FDA DevicesBrand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: no
DJO, LLC
FDA DevicesClass II
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: no
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
May 20, 2026DJO, LLC
Vehicle RecallNHTSA
NHTSALippert - Incorrectly Tightened Shock Bolts
Lippert
NHTSASUSPENSION
Lippert - Incorrectly Tightened Shock Bolts
Broken shock retainer bolt heads and washers may detach and become a road hazard, increasing the risk of a crash.
May 20, 2026Lippert
Medical DeviceFDA Devices
FDA DevicesRevolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
GE Medical Systems, LLC
FDA DevicesClass II
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
May 20, 2026GE Medical Systems, LLC