State

Massachusetts product recalls

72,984 recalls have nationwide distribution and so reach Massachusetts. 8,211 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total: 8,211
Critical: 1,171
Severe: 2,013
Most recent: 2026-09-16

Of the 8,211 recalls naming Massachusetts we have scored against our rubric, 1,171 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,013 (25%) are Severe.

Which agencies issued them

These figures cover only the 8,211 recalls whose distribution notice names Massachusetts specifically. The 72,984 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6751–6775 of 81195

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-1835-2025·2025-06-04
Ortho Clinical Diagnostics Total Bili-Alkp XT Reagent Recall
Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Total Bili-Alkp XT (L-Sequester) reagent due to cold chain storage failures during transit caused by severe thunderstorms, which may result in incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1845-2025·2025-06-04
Abbott Diagnostics HIV Combo Calibrator Affected by Cold Chain Exposure
Abbott Diagnostics ARCHITECT HIV COMBO Calibrator units may have been exposed to improper storage temperatures due to transit delays during severe thunderstorms, potentially affecting test accuracy.
Product
ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1853-2025·2025-06-04
Abbott Diagnostics Alinity I Anti-CCPS Reagent Recall
Abbott Diagnostics Alinity I Anti-CCPS Reagent is being recalled due to transit delays from severe thunderstorms that may have exposed the product to storage conditions outside the manufacturer's recommendations, potentially causing incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
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-1837-2025·2025-06-04
ORTHO CLINICAL DIAGNOSTICS VITROS BUN Reagent Recall Nationwide
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN clinical reagent is being recalled due to transit delays caused by severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1829-2025·2025-06-04
BD Microbiology MacConkey II Agar Media Storage Condition Recall
BD Microbiology MacConkey II Agar media may have been stored outside recommended temperature conditions due to transit delays from severe thunderstorms, potentially resulting in incorrect or delayed test results.
Product
BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
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-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-1822-2025·2025-06-04
Siemens ADVIA Centaur HCY Calibrator packs recalled for calibrator instability
Siemens Healthcare Diagnostics is recalling certain lots of ADVIA Centaur HCY Calibrator (2 Pack) due to calibrator instability that causes increased positive bias and fails to meet reference interval specifications in the Instructions for Use.
Product
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
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 (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-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-1832-2025·2025-06-04
ORTHO CLINICAL DIAGNOSTICS VITROS Phosphorus Reagent Recall
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS reagent units may have been stored outside recommended cold chain conditions due to severe thunderstorms, risking incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1841-2025·2025-06-04
Abbott Diagnostics Probe Conditioning Solution Recall
Abbott Diagnostics Probe Conditioning Solution for Architect analyzers is being recalled due to cold chain failures during severe thunderstorms. Products may have been stored outside recommended conditions, risking incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1854-2025·2025-06-04
Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set Recall
Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set units may have been exposed to improper storage conditions during transit due to severe thunderstorms, which could result in incorrect or delayed test results.
Product
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1836-2025·2025-06-04
Ortho Clinical Diagnostics Anti-B Bioclone diagnostic reagent recalled
Ortho Clinical Diagnostics Anti-B Bioclone reagent is recalled due to cold-chain failures during transit caused by severe thunderstorms. Products may have been stored outside recommended conditions, potentially increasing the risk of incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
Category
Medical Device
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-1843-2025·2025-06-04
Abbott Diagnostics ARC Anti-TPO Assay Reagent Affected by Transit Delays
Abbott Diagnostics ARC Anti-TPO Assay 100TST B Reagent is being recalled because transit delays due to severe thunderstorms may have caused products to be stored outside recommended temperature conditions, increasing the risk of incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
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-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 (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-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-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