Safety Recalls

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17,553 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 1,651–1,700 of 17,553

Medical Device Recall · May 21, 2026
Medline Industries, LP
Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Class II
Medical Device Recall · May 21, 2026
Bard Access Systems, Inc.
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Class II
Medical Device Recall · May 21, 2026
Instrumentation Laboratory
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critic
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Class II
Medical Device Recall · May 21, 2026
Medline Industries, LP
Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Nu
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Class II
Medical Device Recall · May 21, 2026
Boston Scientific Corporation
CRE Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Class II
Medical Device Recall · May 21, 2026
Medical Action Industries, Inc. 306
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
Class II
Medical Device Recall · May 21, 2026
Boston Scientific Corporation
CRE Wireguided 8-10mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Class II
Drug Recall · May 21, 2026
Keystone Industries
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC
Defective container:may contain bottles with incomplete seals
Class II
Medical Device Recall · May 21, 2026
Medline Industries, LP
Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" R
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Class II
Medical Device Recall · May 21, 2026
Bard Access Systems, Inc.
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Class II
Medical Device Recall · May 21, 2026
Papablic Inc
Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Potential for brush heads to break.
Class II
Drug Recall · May 21, 2026
Keystone Industries
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Defective container:may contain bottles with incomplete seals
Class II
Medical Device Recall · May 21, 2026
Papablic Inc
Papablic Replacement Brush Heads. Model Number: Papablic18B
Potential for brush heads to break.
Class II
Medical Device Recall · May 21, 2026
Instrumentation Laboratory
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Class II
Food Recall · May 21, 2026
Fairhope Roasting Company
Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon plastic jugs, UPC 852236006062, for food service only
Product requires refrigeration but the label is missing a "Keep Refrigerated" statement
Class II
Medical Device Recall · May 20, 2026
RAYSEARCH LABORATORIES AB
RayCare 2024A SP4. Oncology Information Systems.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Class II
Medical Device Recall · May 20, 2026
Siemens Medical Solutions USA, Inc
ARTIS icono biplane. Model Number: 11327600.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Class II
Medical Device Recall · May 20, 2026
Zimmer, Inc.
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Class II
Medical Device Recall · May 20, 2026
Zimmer, Inc.
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Class II
Medical Device Recall · May 20, 2026
United Orthopedic Corp.
Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Class II
Medical Device Recall · May 20, 2026
Zimmer, Inc.
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Class II
Medical Device Recall · May 20, 2026
Zimmer, Inc.
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Class II
Medical Device Recall · May 20, 2026
Siemens Medical Solutions USA, Inc
ARTIS icono floor. Model Number: 11327700.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Class II
Medical Device Recall · May 20, 2026
United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337,
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Class II
Medical Device Recall · May 20, 2026
Insulet Corporation
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.
Class I
Medical Device Recall · May 20, 2026
Insulet Corporation
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single P
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.
Class I
Vehicle Recall · May 20, 2026
Alliance RV, LLC
2023 ALLIANCE RV VALOR, 2024 ALLIANCE RV PARADIGM, 2024 ALLIANCE RV VALOR, 2025 ALLIANCE RV VALOR
The heating pad may overheat in the battery compartment, increasing the risk of a fire.
Unclassified
Medical Device Recall · May 20, 2026
United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A P
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Class II
Medical Device Recall · May 20, 2026
Insulet Corporation
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-672
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.
Class I
Vehicle Recall · May 20, 2026
Toyota Motor Engineering & Manufacturing
2024 TOYOTA TUNDRA
A loss of drive power increases the risk of a crash.
Unclassified
Vehicle Recall · May 20, 2026
Volkswagen Group of America, Inc.
2024 VOLKSWAGEN TIGUAN
A rearview camera that does not display an image can reduce the driver's rear view, increasing the risk of a crash.
Unclassified
Medical Device Recall · May 20, 2026
RAYSEARCH LABORATORIES AB
RayCare 2024A SP1. Oncology Information Systems.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Class II
Medical Device Recall · May 20, 2026
Siemens Medical Solutions USA, Inc
ARTIS icono ceiling. Model Number: 11328100.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Class II
Medical Device Recall · May 20, 2026
United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Sur
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Class II
Medical Device Recall · May 20, 2026
Zimmer, Inc.
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Class II
Food Recall · May 20, 2026
Hometown Food Company
Birch Benders Sweet Potato Pancake and Waffle Mix 12oz bag, UPC 8 1000156076 8, 6 bags per case
Undeclared egg
Class I
Medical Device Recall · May 19, 2026
DEPUY (IRELAND)
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Nu
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Class II
Medical Device Recall · May 19, 2026
Howmedica Osteonics Corp.
TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
Class II
Medical Device Recall · May 19, 2026
W L Gore & Associates, Inc.
GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB0817
Due to catheter separation
Class II
Vehicle Recall · May 19, 2026
Hyundai Motor America
2025 HYUNDAI SANTA CRUZ, 2025 HYUNDAI TUCSON HYBRID, 2025 HYUNDAI TUCSON, 2025 HYUNDAI TUCSON PLUG-IN HYBRID
Unexpected braking increases the risk of a crash.
Unclassified
Medical Device Recall · May 19, 2026
AVID Medical, Inc.
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Class II
Medical Device Recall · May 19, 2026
AVID Medical, Inc.
1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03;
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Class II
Medical Device Recall · May 19, 2026
American Contract Systems Inc
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, M
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Class II
Vehicle Recall · May 19, 2026
Hyundai Motor America
2025 HYUNDAI IONIQ 5
A loss of vehicle control increases the risk of a crash.
Unclassified
Vehicle Recall · May 19, 2026
Tesla, Inc.
2025 TESLA MODEL Y
Missing weight information provided by the label may lead to unintentionally overloading the vehicle, increasing the risk of a crash.
Unclassified
Medical Device Recall · May 19, 2026
Howmedica Osteonics Corp.
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
Class II
Medical Device Recall · May 19, 2026
American Contract Systems Inc
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Class II
Medical Device Recall · May 19, 2026
AVID Medical, Inc.
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
Class II
Medical Device Recall · May 19, 2026
Medtronic Navigation, Inc.-Boxborough
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Class II
Medical Device Recall · May 19, 2026
DEPUY (IRELAND)
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Class II