State

North Carolina product recalls

72,984 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 72,984 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6851–6875 of 83245

ModerateFDA (Devices)·Z-1882-2025·2025-06-04
Segmental Stem Bowed 152MM components recall potential seal breach
Onkos Surgical is recalling Segmental Stem, Canal Filling, Bowed 152MM components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise the sterility of the device.
Product
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1858-2025·2025-06-04
Catalyst+ Patient Positioning Software May Fail to Apply Rotation Correctly
C-RAD POSITIONING AB has recalled Catalyst+ and related patient positioning devices due to a software issue where field rotation may not be applied correctly during scanning.
Product
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Cataly
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0452-2025·2025-06-04
Theophylline Extended-Release Tablets recalled for dissolution test failure
Glenmark Pharmaceuticals is recalling Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, due to out-of-specification results on dissolution testing. The recall affects 8,520 bottles distributed nationwide.
Product
THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1855-2025·2025-06-04
HemoCue Glucose Control Kit Affected by Improper Storage During Transit
HemoCue Glucose Aqueous Control Kit units may have been stored outside recommended conditions due to transit delays during severe thunderstorms, potentially affecting test result accuracy.
Product
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1846-2025·2025-06-04
Abbott Point of Care Creatinine Test Cartridges Recalled for Storage Failure
McKesson Medical-Surgical is recalling Abbott Point of Care Test Creatinine I-STAT cartridges distributed nationwide after transit delays during severe thunderstorms caused improper storage conditions, increasing the risk of incorrect or delayed test results.
Product
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1884-2025·2025-06-04
Male-Female Midsection components from ELEOS Segmental Limb Salvage System
Onkos Surgical is recalling Male-Female Midsection components used in the ELEOS Segmental Limb Salvage System due to potential for breach of Tyvek seals. The recall affects 99 units distributed across 18 states.
Product
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Mal
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1847-2025·2025-06-04
Abbott ARCHITECT HBSAG Assay Reagent Recall Due to Storage Condition Failure
Abbott ARCHITECT HBSAG Assay reagent may have been stored outside recommended conditions due to transit delays caused by severe thunderstorms, potentially resulting in incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1861-2025·2025-06-04
Straumann Plus Initial Drill missing laser engraving marking
Straumann USA LLC is recalling Plus Initial Drill units (Article Number 103.170, Lot LNWT8) because the batch was produced without the required 7 mm laser engraving marking.
Product
Plus Initial Drill, Article Number: 103.170;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1842-2025·2025-06-04
Abbott Diagnostics ARCH AUSAB Anti-HBS Reagent Recall
Abbott Diagnostics ARCH AUSAB Anti-HBS reagent units may have been stored outside recommended temperature conditions due to transit delays caused by severe thunderstorms, potentially leading to incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1856-2025·2025-06-04
Glidewell HT Implant Twist Drill recalled due to packaging mix-up
Prismatik Dentalcraft is recalling Glidewell HT Implant Twist Drill 1.5 x 8 mm devices due to a packaging mix-up that resulted in incorrect finished devices being placed in packages.
Product
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1825-2025·2025-06-04
Abbott Rapid DX Cholestec LDX Lipid Profile Test Cassettes Recall
Abbott Rapid DX Cholestec LDX Lipid Profile test cassettes are being recalled because transit delays caused by severe thunderstorms may have exposed products to storage temperatures outside recommended conditions, which could result in incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0447-2025·2025-06-04
Bromfenac Ophthalmic Solution 0.09% Recalled for Failed Impurities Specifications
Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% nationwide due to failed impurities and degradation specifications. Three affected lots expire May 31, 2025.
Product
BROMFENAC OPHTHALMIC SOLUTION 0.09% — BROMFENAC OPHTHALMIC SOLUTION 0.09% (BROMFENAC OPHTHALMIC SOLUTION 0.09%)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1859-2025·2025-06-04
Ultrasonic Cleaning Systems Triton 36 and 72 recalled
Ultra Clean Systems, Inc. is recalling Ultrasonic Cleaning Systems Triton 36 and Triton 72 models due to carbon filter sensors breaking down from electrochemical degradation. The defect was identified during routine preventative maintenance checks.
Product
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1851-2025·2025-06-04
Abbott Diagnostics Architect Progesterone Reagent Storage Condition Recall
Abbott Diagnostics Architect Progesterone (100 tests) reagent is being recalled due to transit delays during severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1876-2025·2025-06-04
VITROS Chemistry Products CRP Slides Incorrectly Labeled Coating Generation
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because the product carton, foil wrapper, and cartridge label were incorrectly marked with "GEN 88" instead of the correct "GEN 83" designation.
Product
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1883-2025·2025-06-04
Ethos Collar Stem components recalled for potential Tyvek seal breach
Onkos Surgical is recalling Ethos Collar Stem components used in limb salvage systems due to potential breach of Tyvek seals. The recall affects 233 units distributed across multiple U.S. states.
Product
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1824-2025·2025-06-04
Abbott Rapid DX Multi Analyte Control Affected by Storage Temperature Excursion
Abbott Rapid DX Multi Analyte Level 1 & 2 control products were exposed to temperatures outside recommended storage conditions due to transit delays caused by severe thunderstorms, which may result in incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1840-2025·2025-06-04
Abbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
Abbott Diagnostics ARC Carbon Dioxide 6x5mL B Calibrator units experienced transit delays due to severe thunderstorms, potentially exposing products to storage conditions outside the manufacturer's recommendations. This may increase the risk of incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2025·2025-06-04
Abbott HbA1c Hemoglobin Afinion Test Kit Cold Chain Failure
Abbott HbA1c Hemoglobin Afinion test kits are being recalled due to transit delays caused by severe thunderstorms that may have exposed products to storage temperatures outside the manufacturer's recommended range, potentially causing incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1827-2025·2025-06-04
HemoCue Glucose 201 Analyzer Microcuvettes Recalled for Storage Conditions
HemoCue INC F/Glucose 201 Analyzer microcuvettes are being recalled due to transit delays caused by severe thunderstorms that may have resulted in storage outside recommended conditions, which could cause incorrect or delayed test results.
Product
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1852-2025·2025-06-04
Abbott Diagnostics Alinity I Free PSA Reagent Affected by Storage Conditions
Abbott Diagnostics Alinity I Free PSA reagent units may have been stored outside recommended conditions due to transit delays from severe thunderstorms, potentially affecting test accuracy or timing.
Product
ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1839-2025·2025-06-04
HemoCue HemoTrol High Control Product Recalled Due to Storage Conditions
HemoCue Inc HemoTrol High Level 3 control product (Catalog No. 171003002) is being recalled because transit delays and severe thunderstorms may have caused it to be stored outside recommended temperature ranges, potentially resulting in incorrect or delayed test results.
Product
HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1831-2025·2025-06-04
Ortho Clinical Diagnostics Vitros Calcium Reagent Recalled Due to Storage Conditions
Ortho Clinical Diagnostics Vitros Calcium (L-Sequester) reagent is being recalled because transit delays caused by severe thunderstorms may have stored products outside recommended cold chain conditions, potentially leading to incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1821-2025·2025-06-04
Atellica IM Homocysteine Calibrator recalled for assay instability
Siemens Healthcare Diagnostics is recalling certain lots of Atellica IM Homocysteine Calibrator because calibrator instability causes increased positive bias and does not meet the assay reference interval requirements.
Product
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1834-2025·2025-06-04
Ortho Clinical Diagnostics Diluent Pack Recall Due to Cold Chain Failure
McKesso Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics FS Diluent Packs due to transit delays from severe thunderstorms that may have caused improper storage conditions. The affected products could produce incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
Category
Medical Device
Distribution
Distributed nationwide