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Integrity Bio-Chemicals LLC

Integrity Bio-Chemicals LLC Recalls

All product recalls associated with Integrity Bio-Chemicals LLC.

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Recall Summary

Total Recalls

1000

Past Year

582

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1381–1400 of 10937 recalls

Biochem HSC 70-LV Sanitizer (Integrity) – Chemical Levels (2023)

CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.

Class IIModerate

FDAOct 18, 2023IN, OK• Integrity Bio-Chemicals LLC

Biochem HSC 70-LM Sanitizer (Integrity) – Chemical Levels (2023)

CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.

Class IIModerate

FDAOct 18, 2023IN, OK• Integrity Bio-Chemicals LLC

Biochem HSC 70-VA Sanitizer (Integrity) – Chemical Levels (2023)

CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.

Class II

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Moderate

FDAOct 18, 2023IN, OK• Integrity Bio-Chemicals LLC

SagiPlan 2.2 (Bebig) – measurement accuracy issue (2023)

Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.

Low

FDAOct 17, 2023MD• Bebig Isotopentechnik Gmbh Robert-Rossle-Str. 10 Berlin Germany

PCF-H190DL Colonovideoscope (Aizu Olympus) – repair defect (2023)

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

High

FDAOct 16, 2023FL, KY, MA +3 more• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

Unity Total Knee System (Corin) – mislabeling risk (2023)

Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

Low

FDAOct 13, 2023IL, MI, TX• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Unity CR Femur (Corin) – mislabeling risk (2023)

Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

Low

FDAOct 13, 2023IL, MI, TX• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Crystal Clear Sodium Hydroxide (Family Health) – Child Safety Issue (2023)

Fire/Burn Risk

This recall involves Family Health Products Crystal Clear Sodium Hydroxide products. Sodium hydroxide is commonly used for soapmaking and cleaning. The sodium hydroxide, also called lye or caustic soda, was sold in a resealable two-pound bag with "CRYSTAL CLEAR", "SODIUM HYDROXIDE", "Protect, Deliver, Clean", and "NaOH" printed in large type.

Moderate

CPSCOct 12, 2023Nationwide• Family Health Products Inc., Omaha, Nebraska

Cardiohelp-i System (Maquet) – weld defect (2023)

It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.

High

FDAOct 12, 2023Nationwide• Maquet Medical Systems USA

RANDOX Total Bilirubin (Randox Laboratories) – Elevated Patient Results (2023)

Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.

Moderate

FDAOct 11, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

VariSoft Infusion Set (Unomedical A/S) – Connector Damage (2023)

The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.

High

FDAOct 11, 2023Nationwide• Unomedical A/S Aaholmvej

BD Alaris Pump Infusion Sets (Becton Dickinson) – DEHP Mislabeling (2023)

Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

Moderate

FDAOct 11, 2023Nationwide• Becton Dickinson & Company

BD Extension Sets (Becton Dickinson) – DEHP Mislabeling (2023)

Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

Moderate

FDAOct 11, 2023Nationwide• Becton Dickinson & Company

BD Gravity Sets (Becton Dickinson) – DEHP Mislabeling (2023)

Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

Moderate

FDAOct 11, 2023Nationwide• Becton Dickinson & Company

CARDIOHELP Emergency Drive (Maquet) – Patient Exposure Risk (2023)

Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.

High

FDAOct 10, 2023Nationwide• Maquet Medical Systems USA

D-Clip Applier (Peter Lazic) – Surgery Failure Risk (2023)

Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.

Moderate

FDAOct 6, 2023Nationwide• Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany

Stay Informed

Integrity Bio-Chemicals LLC Recalls

Recall Summary

Biochem HSC 70-LV Sanitizer (Integrity) – Chemical Levels (2023)

Biochem HSC 70-LM Sanitizer (Integrity) – Chemical Levels (2023)

Biochem HSC 70-VA Sanitizer (Integrity) – Chemical Levels (2023)

SagiPlan 2.2 (Bebig) – measurement accuracy issue (2023)

PCF-H190DL Colonovideoscope (Aizu Olympus) – repair defect (2023)

PCF-H190L Colonovideoscope (Aizu Olympus) – repair defect (2023)

GIF-HQ190 Videoscope (Aizu Olympus) – repair defect (2023)

GIF-H190 Videoscope (Aizu Olympus) – repair defect (2023)

CF-HQ190L Colonovideoscope (Aizu Olympus) – repair defect (2023)

Unity Total Knee System (Corin) – mislabeling risk (2023)

Unity CR Femur (Corin) – mislabeling risk (2023)

Crystal Clear Sodium Hydroxide (Family Health) – Child Safety Issue (2023)

Cardiohelp-i System (Maquet) – weld defect (2023)

RANDOX Total Bilirubin (Randox Laboratories) – Elevated Patient Results (2023)

VariSoft Infusion Set (Unomedical A/S) – Connector Damage (2023)

BD Alaris Pump Infusion Sets (Becton Dickinson) – DEHP Mislabeling (2023)

BD Extension Sets (Becton Dickinson) – DEHP Mislabeling (2023)

BD Gravity Sets (Becton Dickinson) – DEHP Mislabeling (2023)

CARDIOHELP Emergency Drive (Maquet) – Patient Exposure Risk (2023)

D-Clip Applier (Peter Lazic) – Surgery Failure Risk (2023)