State

North Carolina product recalls

72,919 recalls have nationwide distribution and so reach North Carolina. 10,261 additional recalls listed North Carolina specifically in their distribution scope.

What the numbers show

Total: 10,261
Critical: 1,476
Severe: 2,520
Most recent: 2026-09-09

Of the 10,261 recalls naming North Carolina we have scored against our rubric, 1,476 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,520 (25%) are Severe.

Which agencies issued them

These figures cover only the 10,261 recalls whose distribution notice names North Carolina specifically. The 72,919 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2301–2325 of 83180

ModerateFDA (Devices)·Z-1836-2026·2026-04-29
Medline left heart kits recalled after 510(k) clearances were rescinded
Medline is recalling a range of custom left heart and catheterization kits because the 510(k) clearances for certain control syringes, guidewires and high-pressure tubing were rescinded.
Product
Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1910-2026·2026-04-29
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 Medical Device Recall
Arrow International is recalling 85 units of the Arrow Echogenic Introducer Needle due to incorrect manufacturing of the liquid adhesive used in the device.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1903-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled Nationwide
Olympus Corporation recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect. The recall affects approximately 2,089 units distributed nationwide and internationally.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0484-2026·2026-04-29
Pantoprazole Sodium Tablets Recalled for Discoloration Issues
Hetero Labs Limited is recalling Pantoprazole Sodium 40 mg delayed-release tablets due to discoloration—some tablets are darker than normal with lighter-colored spots. The firm received five complaints about the affected tablets.
Product
PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1887-2026·2026-04-29
Medline Convenience Kits with 10mL Syringes recalled for unapproved design changes
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0521-2026·2026-04-29
Claravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
Teva Pharmaceuticals is recalling Claravis (isotretinoin) 10 mg capsules due to failure to meet impurity specifications. The affected lots were distributed nationwide in the USA, Puerto Rico, and the Virgin Islands.
Product
CLARAVIS — CLARAVIS (ISOTRETINOIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1937-2026·2026-04-29
Protocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR
Foundation Medicine is recalling Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx due to potential spontaneous closures of Hamilton HxRunControl software during protocol execution.
Product
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.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1909-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Levers Failure Risk
Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2330) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2026·2026-04-29
Medline Namic Control Syringes recalled due to rescinded FDA clearance
Medline Industries is recalling Medline Namic Control Syringes (Model DYNJSYR10CWRB) because the FDA has rescinded their 510(k) regulatory clearance. The recall affects 24,170 units distributed nationwide.
Product
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1902-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure Risk
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2114) because the Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting equipment operation and patient safety during endoscope reprocessing.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1918-2026·2026-04-29
Rover Mobile X-ray System may malfunction and become inoperable
Micro-X Ltd. is recalling certain Rover Mobile X-ray Systems (models MXU-RV35 and MXU-RV71) because the X-ray generator may malfunction, rendering the device inoperable.
Product
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1839-2026·2026-04-29
Medline ENT and Vascular Kits with Rescinded Regulatory Clearances
Medline Industries is recalling three ENT and vascular kits (513 units nationwide) because their regulatory clearances for certain components—Control Syringes, Guidewires, and/or High-Pressure Tubing—have been rescinded.
Product
Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1900-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2112) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2026·2026-04-29
Omega-3-Acid Ethyl Esters capsules recalled for failed capsule specifications
The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters capsules (1 gram, 50-count cartons) due to failed capsule specifications discovered during routine stability testing.
Product
OMEGA-3-ACID ETHYL ESTERS — OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1832-2026·2026-04-29
Medline Angio Cath Pack regulatory clearance rescinded nationwide
Medline Industries is recalling certain Angio Cath Pack kits (Model DYNJ24517D, Lot 25CBA224) because their regulatory 510(k) clearances have been rescinded by the FDA.
Product
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1914-2026·2026-04-29
Arrow Pressure Injectable Central Venous Catheters Recalled
Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1847-2026·2026-04-29
Medline Hysteroscopy and Sling Packs subject to regulatory rescission
FDA has rescinded 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in two Medline medical device kits distributed nationwide.
Product
Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1835-2026·2026-04-29
Medline Catheterization and Angiography Kits Regulatory Clearance Rescinded
Medline Industries has had its 510(k) regulatory clearances rescinded for certain Control Syringes, Guidewires, and High-Pressure Tubing used in a large number of catheterization and angiography kits. The kits are distributed nationwide.
Product
Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT57
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1911-2026·2026-04-29
Arrow Radial Artery Catheterization Kit recalled for incorrect adhesive
Arrow International is recalling Arrow Radial Artery Catheterization Kits due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 675 units distributed nationwide.
Product
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)25121
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1908-2026·2026-04-29
Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2138) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers. The defect could affect proper tube attachment during endoscope reprocessing.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0498-2026·2026-04-29
Lactated Ringers Irrigation 3000 mL Bags Recall: Sterility Concern
B. Braun Medical Inc. is recalling Lactated Ringers Irrigation 3000 mL bags due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.
Product
LACTATED RINGERS IRRIGATION — LACTATED RINGERS IRRIGATION (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1883-2026·2026-04-29
Medline convenience kits recalled over unapproved syringe design changes
Medline is recalling convenience kits containing select 10 mL polycarbonate colored syringes because of unapproved design changes made outside the 510(k) clearance. 270,311 units are affected.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1881-2026·2026-04-29
Medline Convenience Kits with Polycarbonate Syringes Unapproved Design Changes
Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJ
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0486-2026·2026-04-29
Furosemide tablets recalled for presence of N-nitroso impurity
Leading Pharma, LLC is recalling Furosemide 80 mg tablets due to the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit, caused by manufacturing deviations.
Product
FUROSEMIDE — FUROSEMIDE (FUROSEMIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1897-2026·2026-04-29
nanOss 3D Bone Graft Substitute Incorrectly Labeled with Five-Year Shelf Life
XTANT Medical Holdings is recalling nanOss 3D Advanced Bone Graft Substitute products due to incorrect labeling showing a 5-year shelf life when the approved shelf life is four years.
Product
nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Gr
Category
Medical Device
Distribution
Distributed nationwide