Merit Medical Systems, Inc.: Inflation Devices and Kits Recalled for Sterile Barrier Defects

Agency Publication Date: October 11, 2024

Summary

Merit Medical Systems is recalling approximately 53,516 inflation devices and custom kits, including popular models like Blue Diamond, basixTOUCH, and MONARCH. These medical devices may contain a small hole in their sterile packaging, which could expose the equipment to harmful germs and pathogens. Use of a contaminated device during medical procedures can lead to serious infections in patients. These units were distributed worldwide between April 2024 and June 2024.

Risk

A breach in the sterile barrier allows pathogens or pyrogens to enter the device. If used, these contaminants can be introduced directly into a patient's body, potentially causing life-threatening infections or inflammatory reactions.

What You Should Do

Locate the device packaging and check the Reference (REF) and Lot numbers to see if your unit is affected. Key models include Blue Diamond (IN7152/C, IN7130/C), basixTOUCH (IN8140/A, IN8130/C), and MONARCH (IN2130/B, IN2530/B).
Confirm the Lot number and Expiration date printed on the label. For example, check for Blue Diamond Lot H2918431 (Exp 4/15/2027) or basixTOUCH Lot H2925218 (Exp 4/22/2027).
Immediately stop using any devices identified as part of the affected lots and quarantine them to prevent accidental use in medical procedures.
Contact your healthcare provider or facility administrator if you believe an affected device was used during a recent procedure.
Contact Merit Medical Systems at 1-800-356-3748 or visit www.merit.com for specific instructions on returning the affected products and to arrange for replacements or potential refunds.
For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Quarantine and Return Affected Units

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Blue Diamond Digital Inflation Device

Model / REF:

IN7152/C

IN7352/C

IN7403/C

IN7802/C

IN7852/C

IN7130/C

UPC Codes:

00884450381168

00884450409879

00884450409886

00884450498743

00884450498750

00884450409855

Lot Numbers:

H2918432 (Exp 4/15/2027)

H2925197 (Exp 4/22/2027)

H2929406 (Exp 4/29/2027)

H2929407 (Exp 4/29/2027)

H2934708 (Exp 5/5/2027)

H2937991 (Exp 6/3/2027)

H2937992 (Exp 5/19/2027)

H2943482 (Exp 5/19/2027)

H2972588 (Exp 6/3/2027)

H2972589 (Exp 5/26/2027)

H2934710 (Exp 5/5/2027)

H2943483 (Exp 4/30/2027)

H2918435 (Exp 4/22/2027)

H2929409 (Exp 4/29/2027)

H2934711 (Exp 5/5/2027)

H2937995 (Exp 5/12/2027)

H2943485 (Exp 5/19/2027)

H2978087 (Exp 6/3/2027)

H2937355 (Exp 9/30/2025)

H2918431 (Exp 4/15/2027)

H2925196 (Exp 4/22/2027)

H2934706 (Exp 5/5/2027)

H2937988 (Exp 6/3/2027)

H2943481 (Exp 5/19/2027)

H2972587 (Exp 5/26/2027)

H2978086 (Exp 6/3/2027)

Product: basixTOUCH Inflation Device

Model / REF:

IN8140/A

UPC Codes:

00884450627105

Lot Numbers:

H2925218 (Exp 4/22/2027)

H2929411 (Exp 4/29/2027)

H2938003 (Exp 4/30/2027)

H2972592 (Exp 4/30/2027)

H2982505 (Exp 12/31/2026)

Product: DiamondTOUCH Digital Inflation Device

Model / REF:

IN9135/A

IN9152/A

UPC Codes:

00884450409640

00884450409657

Lot Numbers:

H2918441 (Exp 4/15/2027)

H2912682 (Exp 4/8/2027)

Product: IntelliSystem Inflation Device

Model / REF:

IN1525/D

UPC Codes:

00884450298015

Lot Numbers:

H2918426 (Exp 4/22/2027)

H2934697 (Exp 1/31/2027)

Product: BlueFIRE Inflation Device

Model / REF:

IN10140

UPC Codes:

00884450363607

Lot Numbers:

H2934827 (Exp 4/30/2027)

Product: MONARCH Inflation Device

Model / REF:

IN2430/B

IN2530/B

IN2130/B

UPC Codes:

00884450298053

00884450298060

00884450298022

Lot Numbers:

H2918428 (Exp 4/22/2027)

H2918429 (Exp 4/22/2027)

H2925194 (Exp 4/22/2027)

H2929405 (Exp 4/29/2027)

H2934699 (Exp 5/5/2027)

H2937986 (Exp 5/12/2027)

H2943479 (Exp 5/26/2027)

H2978085 (Exp 6/3/2027)

H2982496 (Exp 6/10/2027)

H2918427 (Exp 4/22/2027)

H2925193 (Exp 4/22/2027)

H2929404 (Exp 4/29/2027)

H2934698 (Exp 5/5/2027)

H2937984 (Exp 5/12/2027)

H2943477 (Exp 6/3/2027)

H2972585 (Exp 5/26/2027)

H2982494 (Exp 6/10/2027)

Product: Custom Inflation Kit

Model / REF (51):

K05-00052M

K05-00053H

K05-00109G

K05-00137K

K05-00296L

K05-00399D

K05-00404C

K05-00410G

K05-00438G

K05-00502F

K05-00564L

K05-00587D

K05-00612Q

K05-00704F

K05-00724F

K05-00793B

K05-00798

K05-00890D

K05-00944D

K05-00956D

K05-01018C

K05-01051

K05-01104G

K05-01140D

K05-01194G

K05-01274D

K05-01304A

K05-01756B

K05-01820B

K05-01853A

K05-01855L

K05-01895A

K05-01933A

K05-02161

K05-02431A

K05-02487A

K05-02489C

K05-02495B

K05-02554

K05-02573

K05-02575

K05-02595

K05-02657A

K05-02810

K05-02887

K05-03069A

K05-03095B

K05-03112

K05-03124

K05-03150

UPC Codes (51):

00884450138120

00884450052921

00884450464533

00884450290316

00884450467824

00884450138298

00884450138304

00884450142295

00884450142301

00884450138427

00884450257166

00884450052952

00884450138519

00884450138588

00884450146538

00884450236987

00884450046951

00884450453629

00884450151631

00884450142448

00884450152324

00884450047057

00884450145401

00884450147931

00884450409091

00884450160596

00884450279014

00884450145449

00884450639115

00884450153864

00884450453667

00884450141458

00884450462768

00884450139738

00884450150191

00884450140468

00884450639177

00884450257326

00884450148372

00884450148884

00884450158500

00884450165881

00884450639214

00884450253083

00884450285923

00884450461440

00884450639429

00884450404492

00884450432631

00884450480045

Lot Numbers (52):

H2934735 (Exp 5/5/2027)

H2943603 (Exp 5/19/2027)

H2918538 (Exp 4/22/2027)

H2918443 (Exp 4/15/2027)

H2925237 (Exp 12/31/2026)

H2918499 (Exp 4/29/2027)

H2929510 (Exp 4/29/2027)

H2918500 (Exp 4/29/2027)

H2918501 (Exp 4/15/2027)

H2918502 (Exp 4/15/2027)

H2918505 (Exp 4/15/2027)

H2934839 (Exp 5/5/2027)

H2918446 (Exp 4/22/2027)

H2925240 (Exp 4/22/2027)

H2918508 (Exp 4/15/2027)

H2918509 (Exp 4/15/2027)

H2918448 (Exp 4/15/2027)

H2925242 (Exp 4/22/2027)

H2918449 (Exp 4/15/2027)

H2918450 (Exp 4/15/2027)

H2918511 (Exp 4/15/2027)

H2925244 (Exp 4/22/2027)

H2925280 (Exp 4/22/2027)

H2925285 (Exp 4/22/2027)

H2925286 (Exp 4/22/2027)

H2925288 (Exp 4/22/2027)

H2918453 (Exp 4/22/2027)

H2972617 (Exp 5/26/2027)

H2929520 (Exp 4/29/2027)

H2929521 (Exp 4/29/2027)

H2918460 (Exp 4/15/2027)

H2918518 (Exp 4/15/2027)

H2929522 (Exp 5/26/2027)

H2918519 (Exp 4/15/2027)

H2918522 (Exp 4/15/2027)

H2929525 (Exp 4/29/2027)

H2918472 (Exp 4/15/2027)

H2938638 (Exp 5/12/2027)

H2925259 (Exp 4/22/2027)

H2934780 (Exp 5/5/2027)

H2918476 (Exp 4/15/2027)

H2938639 (Exp 5/12/2027)

H2918525 (Exp 4/15/2027)

H2918480 (Exp 4/15/2027)

H2929528 (Exp 4/29/2027)

H2918527 (Exp 4/29/2027)

H2938301 (Exp 3/31/2027)

H2925319 (Exp 4/22/2027)

H2938650 (Exp 5/12/2027)

H2934820 (Exp 5/5/2027)

Product: basixSKY Inflation Device

Model / REF:

SKY1802

UPC Codes:

00884450822500

Lot Numbers:

H2925228 (Exp 11/30/2026)

H2934728 (Exp 11/30/2026)

Product: basixTOUCH Inflation Device (Extended Models)

Model / REF:

IN8130/JPC

IN8152/C

IN8302/C

IN8352/C

IN8802/C

IN8130/C

UPC Codes:

00884450621073

00884450621301

00884450621325

00884450621349

00884450621417

00884450621059

Lot Numbers:

H2929530 (Exp 4/29/2027)

H2925219 (Exp 4/22/2027)

H2929412 (Exp 4/29/2027)

H2938005 (Exp 5/12/2027)

H2943498 (Exp 5/19/2027)

H2972593 (Exp 5/26/2027)

H2978092 (Exp 6/3/2027)

H2925221 (Exp 4/22/2027)

H2934719 (Exp 5/5/2027)

H2925222 (Exp 4/22/2027)

H2934720 (Exp 5/12/2027)

H2943517 (Exp 5/19/2027)

H2972598 (Exp 5/26/2027)

H2925215 (Exp 4/22/2027)

H2929410 (Exp 4/29/2027)

H2934714 (Exp 5/5/2027)

H2937998 (Exp 5/12/2027)

H2943487 (Exp 5/19/2027)

H2972590 (Exp 5/26/2027)

H2978089 (Exp 6/3/2027)

H2989571 (Exp 6/17/2027)

Product: StabiliT TOUCH Syringe

Model / REF:

IN8VCF/B

UPC Codes:

00884450662144

Lot Numbers:

H2918440 (Exp 5/31/2027)

H2938015 (Exp 7/26/2027)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95343

Status: Active

Manufacturer: Merit Medical Systems, Inc.

Sold By: Hospital supply distributors; Direct medical sales; Authorized dealers

Manufactured In: United States

Units Affected: 10 products (14,120; 1952; 290; 429; 5; 12,910; 7,099; 70; 16,439; 202)

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Locate the device packaging and check the Reference (REF) and Lot numbers to see if your unit is affected. Key models include Blue Diamond (IN7152/C, IN7130/C), basixTOUCH (IN8140/A, IN8130/C), and MONARCH (IN2130/B, IN2530/B).

Confirm the Lot number and Expiration date printed on the label. For example, check for Blue Diamond Lot H2918431 (Exp 4/15/2027) or basixTOUCH Lot H2925218 (Exp 4/22/2027).

Immediately stop using any devices identified as part of the affected lots and quarantine them to prevent accidental use in medical procedures.

Contact your healthcare provider or facility administrator if you believe an affected device was used during a recent procedure.

Contact Merit Medical Systems at 1-800-356-3748 or visit www.merit.com for specific instructions on returning the affected products and to arrange for replacements or potential refunds.

For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Blue Diamond Digital Inflation Device

Model / REF:

IN7152/C

IN7352/C

IN7403/C

IN7802/C

IN7852/C

IN7130/C

UPC Codes:

00884450381168

00884450409879

00884450409886

00884450498743

00884450498750

00884450409855

Lot Numbers:

H2918432 (Exp 4/15/2027)

H2925197 (Exp 4/22/2027)

H2929406 (Exp 4/29/2027)

H2929407 (Exp 4/29/2027)

H2934708 (Exp 5/5/2027)

H2937991 (Exp 6/3/2027)

H2937992 (Exp 5/19/2027)

H2943482 (Exp 5/19/2027)

H2972588 (Exp 6/3/2027)

H2972589 (Exp 5/26/2027)

H2934710 (Exp 5/5/2027)

H2943483 (Exp 4/30/2027)

H2918435 (Exp 4/22/2027)

H2929409 (Exp 4/29/2027)

H2934711 (Exp 5/5/2027)

H2937995 (Exp 5/12/2027)

H2943485 (Exp 5/19/2027)

H2978087 (Exp 6/3/2027)

H2937355 (Exp 9/30/2025)

H2918431 (Exp 4/15/2027)

H2925196 (Exp 4/22/2027)

H2934706 (Exp 5/5/2027)

H2937988 (Exp 6/3/2027)

H2943481 (Exp 5/19/2027)

H2972587 (Exp 5/26/2027)

H2978086 (Exp 6/3/2027)

Product: basixTOUCH Inflation Device

Model / REF:

IN8140/A

UPC Codes:

00884450627105

Lot Numbers:

H2925218 (Exp 4/22/2027)

H2929411 (Exp 4/29/2027)

H2938003 (Exp 4/30/2027)

H2972592 (Exp 4/30/2027)

H2982505 (Exp 12/31/2026)

Product: DiamondTOUCH Digital Inflation Device

Model / REF:

IN9135/A

IN9152/A

UPC Codes:

00884450409640

00884450409657

Lot Numbers:

H2918441 (Exp 4/15/2027)

H2912682 (Exp 4/8/2027)

Product: IntelliSystem Inflation Device

Model / REF:

IN1525/D

UPC Codes:

00884450298015

Lot Numbers:

H2918426 (Exp 4/22/2027)

H2934697 (Exp 1/31/2027)

Product: BlueFIRE Inflation Device

Model / REF:

IN10140

UPC Codes:

00884450363607

Lot Numbers:

H2934827 (Exp 4/30/2027)

Product: MONARCH Inflation Device

Model / REF:

IN2430/B

IN2530/B

IN2130/B

UPC Codes:

00884450298053

00884450298060

00884450298022

Lot Numbers:

H2918428 (Exp 4/22/2027)

H2918429 (Exp 4/22/2027)

H2925194 (Exp 4/22/2027)

H2929405 (Exp 4/29/2027)

H2934699 (Exp 5/5/2027)

H2937986 (Exp 5/12/2027)

H2943479 (Exp 5/26/2027)

H2978085 (Exp 6/3/2027)

H2982496 (Exp 6/10/2027)

H2918427 (Exp 4/22/2027)

H2925193 (Exp 4/22/2027)

H2929404 (Exp 4/29/2027)

H2934698 (Exp 5/5/2027)

H2937984 (Exp 5/12/2027)

H2943477 (Exp 6/3/2027)

H2972585 (Exp 5/26/2027)

H2982494 (Exp 6/10/2027)

Product: Custom Inflation Kit

Model / REF (51):

K05-00052M

K05-00053H

K05-00109G

K05-00137K

K05-00296L

K05-00399D

K05-00404C

K05-00410G

K05-00438G

K05-00502F

K05-00564L

K05-00587D

K05-00612Q

K05-00704F

K05-00724F

K05-00793B

K05-00798

K05-00890D

K05-00944D

K05-00956D

K05-01018C

K05-01051

K05-01104G

K05-01140D

K05-01194G

K05-01274D

K05-01304A

K05-01756B

K05-01820B

K05-01853A

K05-01855L

K05-01895A

K05-01933A

K05-02161

K05-02431A

K05-02487A

K05-02489C

K05-02495B

K05-02554

K05-02573

K05-02575

K05-02595

K05-02657A

K05-02810

K05-02887

K05-03069A

K05-03095B

K05-03112

K05-03124

K05-03150

UPC Codes (51):

00884450138120

00884450052921

00884450464533

00884450290316

00884450467824

00884450138298

00884450138304

00884450142295

00884450142301

00884450138427

00884450257166

00884450052952

00884450138519

00884450138588

00884450146538

00884450236987

00884450046951

00884450453629

00884450151631

00884450142448

00884450152324

00884450047057

00884450145401

00884450147931

00884450409091

00884450160596

00884450279014

00884450145449

00884450639115

00884450153864

00884450453667

00884450141458

00884450462768

00884450139738

00884450150191

00884450140468

00884450639177

00884450257326

00884450148372

00884450148884

00884450158500

00884450165881

00884450639214

00884450253083

00884450285923

00884450461440

00884450639429

00884450404492

00884450432631

00884450480045

Lot Numbers (52):

H2934735 (Exp 5/5/2027)

H2943603 (Exp 5/19/2027)

H2918538 (Exp 4/22/2027)

H2918443 (Exp 4/15/2027)

H2925237 (Exp 12/31/2026)

H2918499 (Exp 4/29/2027)

H2929510 (Exp 4/29/2027)

H2918500 (Exp 4/29/2027)

H2918501 (Exp 4/15/2027)

H2918502 (Exp 4/15/2027)

H2918505 (Exp 4/15/2027)

H2934839 (Exp 5/5/2027)

H2918446 (Exp 4/22/2027)

H2925240 (Exp 4/22/2027)

H2918508 (Exp 4/15/2027)

H2918509 (Exp 4/15/2027)

H2918448 (Exp 4/15/2027)

H2925242 (Exp 4/22/2027)

H2918449 (Exp 4/15/2027)

H2918450 (Exp 4/15/2027)

H2918511 (Exp 4/15/2027)

H2925244 (Exp 4/22/2027)

H2925280 (Exp 4/22/2027)

H2925285 (Exp 4/22/2027)

H2925286 (Exp 4/22/2027)

H2925288 (Exp 4/22/2027)

H2918453 (Exp 4/22/2027)

H2972617 (Exp 5/26/2027)

H2929520 (Exp 4/29/2027)

H2929521 (Exp 4/29/2027)

H2918460 (Exp 4/15/2027)

H2918518 (Exp 4/15/2027)

H2929522 (Exp 5/26/2027)

H2918519 (Exp 4/15/2027)

H2918522 (Exp 4/15/2027)

H2929525 (Exp 4/29/2027)

H2918472 (Exp 4/15/2027)

H2938638 (Exp 5/12/2027)

H2925259 (Exp 4/22/2027)

H2934780 (Exp 5/5/2027)

H2918476 (Exp 4/15/2027)

H2938639 (Exp 5/12/2027)

H2918525 (Exp 4/15/2027)

H2918480 (Exp 4/15/2027)

H2929528 (Exp 4/29/2027)

H2918527 (Exp 4/29/2027)

H2938301 (Exp 3/31/2027)

H2925319 (Exp 4/22/2027)

H2938650 (Exp 5/12/2027)

H2934820 (Exp 5/5/2027)

Product: basixSKY Inflation Device

Model / REF:

SKY1802

UPC Codes:

00884450822500

Lot Numbers:

H2925228 (Exp 11/30/2026)

H2934728 (Exp 11/30/2026)

Product: basixTOUCH Inflation Device (Extended Models)

Model / REF:

IN8130/JPC

IN8152/C

IN8302/C

IN8352/C

IN8802/C

IN8130/C

UPC Codes:

00884450621073

00884450621301

00884450621325

00884450621349

00884450621417

00884450621059

Lot Numbers:

H2929530 (Exp 4/29/2027)

H2925219 (Exp 4/22/2027)

H2929412 (Exp 4/29/2027)

H2938005 (Exp 5/12/2027)

H2943498 (Exp 5/19/2027)

H2972593 (Exp 5/26/2027)

H2978092 (Exp 6/3/2027)

H2925221 (Exp 4/22/2027)

H2934719 (Exp 5/5/2027)

H2925222 (Exp 4/22/2027)

H2934720 (Exp 5/12/2027)

H2943517 (Exp 5/19/2027)

H2972598 (Exp 5/26/2027)

H2925215 (Exp 4/22/2027)

H2929410 (Exp 4/29/2027)

H2934714 (Exp 5/5/2027)

H2937998 (Exp 5/12/2027)

H2943487 (Exp 5/19/2027)

H2972590 (Exp 5/26/2027)

H2978089 (Exp 6/3/2027)

H2989571 (Exp 6/17/2027)

Product: StabiliT TOUCH Syringe

Model / REF:

IN8VCF/B

UPC Codes:

00884450662144

Lot Numbers:

H2918440 (Exp 5/31/2027)

H2938015 (Exp 7/26/2027)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95343

Status: Active

Manufacturer: Merit Medical Systems, Inc.

Sold By: Hospital supply distributors; Direct medical sales; Authorized dealers

Manufactured In: United States

Units Affected: 10 products (14,120; 1952; 290; 429; 5; 12,910; 7,099; 70; 16,439; 202)