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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95343

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 19, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Merit Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C

Z-0064-2025
Recall number
Z-0064-2025
Initiated
August 19, 2024
Classification
Class II
Status
Ongoing
Quantity
14,120

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Code information

REF/UDI-DI/Lot(Expiration): IN7152/C/00884450381168/H2918432(4/15/2027), H2925197(4/22/2027), H2929406(4/29/2027), H2929407(4/29/2027, H2934708(5/5/2027), H2937991(6/3/2027), H2937992(5/19/2027), H2943482(5/19/2027), H2972588(6/3/2027), H2972589(5/26/2027).: . IN7352/C/00884450409879/H2934710(5/5/2027). IN7403/C/00884450409886/H2943483(4/30/2027). IN7802/C/00884450498743/H2918435(4/22/2027), H2929409(4/29/2027), H2934711(5/5/2027), H2937995(5/12/2027), H2943485(5/19/2027), H2978087(6/3/2027). IN7852/C/00884450498750/H2937355(9/30/2025). IN7130/C/00884450409855/H2918431(4/15/2027), H2925196(4/22/2027), H2934706(5/5/2027), H2937988(6/3/2027), H2943481(5/19/2027), H2972587(5/26/2027), H2978086(6/3/2027).

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

device · product 2 of 10

basixTOUCH Inflation Device, REF: IN8140/A

Z-0065-2025
Recall number
Z-0065-2025
Initiated
August 19, 2024
Classification
Class II
Status
Ongoing
Quantity
1952

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Code information

REF/UDI-DI/Lot(Expiration): IN8140/A/00884450627105/H2925218(4/22/2027), H2929411(4/29/2027), H2938003(4/30/2027), H2972592(4/30/2027), H2982505(12/31/2026).

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

device · product 3 of 10

DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A

Z-0066-2025
Recall number
Z-0066-2025
Initiated
August 19, 2024
Classification
Class II
Status
Ongoing
Quantity
290

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Code information

REF/UDI-DI/Lot(Expiration): IN9135/A/00884450409640/H2918441(4/15/2027). IN9152/A/00884450409657/H2912682(4/8/2027)

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

device · product 4 of 10

IntelliSystem Inflation Device, REF: IN1525/D

Z-0067-2025
Recall number
Z-0067-2025
Initiated
August 19, 2024
Classification
Class II
Status
Ongoing
Quantity
429

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Code information

REF/UDI-DI/Lot(Expiration): IN1525/D/00884450298015/ H2918426(4/22/2027), H2934697(1/31/2027)

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

device · product 5 of 10

BlueFIRE Inflation Device, REF: IN10140

Z-0068-2025
Recall number
Z-0068-2025
Initiated
August 19, 2024
Classification
Class II
Status
Ongoing
Quantity
5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Code information

REF/UDI-DI/Lot(Expiration): IN10140/00884450363607/H2934827(4/30/2027)

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

device · product 6 of 10

MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B

Z-0069-2025
Recall number
Z-0069-2025
Initiated
August 19, 2024
Classification
Class II
Status
Ongoing
Quantity
12,910

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Code information

REF/UDI-DI/Lot(Expiration): IN2430/B/00884450298053/H2918428(4/22/2027). IN2530/B/00884450298060/H2918429(4/22/2027), H2925194(4/22/2027), H2929405(4/29/2027), H2934699(5/5/2027), H2937986(5/12/2027), H2943479(5/26/2027), H2978085(6/3/2027), H2982496(6/10/2027). IN2130/B/00884450298022/H2918427(4/22/2027), H2925193(4/22/2027), H2929404(4/29/2027), H2934698(5/5/2027), H2937984(5/12/2027), H2943477(6/3/2027), H2972585(5/26/2027), H2982494(6/10/2027).

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

device · product 7 of 10

Custom Inflation Kit, REF: 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, K05-00890D, 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, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G

Z-0070-2025
Recall number
Z-0070-2025
Initiated
August 19, 2024
Classification
Class II
Status
Ongoing
Quantity
7,099

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Code information

REF/UDI-DI/Lot(Expiration): K05-00052M/00884450138120/H2934735(5/5/2027), H2943603(5/19/2027). K05-00053H/00884450052921/H2918538(4/22/2027), H2934736(5/5/2027). K05-00109G/00884450464533/H2918443(4/15/2027), H2925236(4/22/2027), H2943604(5/19/2027). K05-00137K/00884450290316/H2925237(12/31/2026), H2934737(5/12/2027). K05-00296L/00884450467824/H2918499(4/29/2027), H2925271(4/29/2027). K05-00399D/00884450138298/H2929510(4/29/2027), H2934739(5/12/2027). K05-00404C/00884450138304/H2918500(4/29/2027). K05-00410G/00884450142295/H2918501(4/15/2027), H2934833(5/12/2027). K05-00438G/00884450142301/H2918502(4/15/2027), H2934834(5/5/2027), H2978145(6/3/2027). K05-00502F/00884450138427/H2918505(4/15/2027), H2934837(5/5/2027). K05-00564L/00884450257166/H2934839(5/5/2027). K05-00587D/00884450052952/H2918446(4/22/2027), H2934744(5/5/2027), H2938620(5/12/2027). K05-00612Q/00884450138519/H2925240(4/22/2027), H2934746(5/5/2027), H2943608(5/26/2027). K05-00704F/00884450138588/H2918508(4/15/2027), H2938622(5/12/2027). K05-00724F/00884450146538/H2918509(4/15/2027). K05-00793B/00884450236987/H2918448(4/15/2027), H2929514(4/29/2027), H2938623(5/12/2027). K05-00798/00884450046951/H2925242(4/22/2027), H2943609(5/19/2027). K05-00890D/00884450453629/H2918449(4/15/2027), H2929515(4/29/2027). K05-00890D/00884450453629/H2934749(5/5/2027), H2943610(5/19/2027). K05-00944D/00884450151631/H2918450(4/15/2027), H2929516(4/29/2027). K05-00956D/00884450142448/H2918511(4/15/2027), H2925278(4/22/2027), H2938625(5/12/2027). K05-01018C/00884450152324/H2925244(4/22/2027), H2938626(5/12/2027). K05-01051/00884450047057/H2925280(4/22/2027). K05-01104G/00884450145401/H2925285(4/22/2027), H2929540(4/29/2027), H2934846(5/5/2027). K05-01140D/00884450147931/H2925286(4/22/2027), H2934847(5/5/2027), H2972616(5/26/2027). K05-01194G/00884450409091/H2925288(4/22/2027). K05-01274D/00884450160596/H2918453(4/22/2027), H2934750(5/12/2027), H2938628(5/12/2027). K05-01304A/00884450279014/H2972617(5/26/2027). K05-01756B/00884450145449/H2929520(4/29/2027). K05-01820B/00884450639115/H2929521(4/29/2027), H2943614(5/19/2027). K05-01853A/00884450153864/H2918460(4/15/2027), H2934761(5/12/2027), H2943615(5/19/2027). K05-01855L/00884450453667/H2918518(4/15/2027), H2978189(6/3/2027). K05-01895A/00884450141458/H2929522(5/26/2027). K05-01933A/00884450462768/H2918519(4/15/2027), H2934855(5/5/2027). K05-02161/00884450139738/H2918522(4/15/2027), H2925298(4/29/2027), H2943617(5/19/2027), H2978192(6/3/2027). K05-02431A/00884450150191/H2929525(4/29/2027). K05-02487A/00884450140468/H2918472(4/15/2027). K05-02489C/00884450639177/H2938638(5/12/2027). K05-02495B/00884450257326/H2925259(4/22/2027), H2934775(5/5/2027). K05-02554/00884450148372/H2934780(5/5/2027). K05-02573/00884450148884/H2918476(4/15/2027). K05-02575/00884450158500/H2938639(5/12/2027). K05-02595/00884450165881/H2918525(4/15/2027), H2929547(4/29/2027), H2938640(5/12/2027). K05-02595/00884450165881/H2972630(5/26/2027), H2982566(6/10/2027). K05-02657A/00884450639214/H2918480(4/15/2027), H2925265(4/29/2027), H2934784(5/5/2027), H2938643(5/12/2027), H2982568(6/10/2027). K05-02810/00884450253083/H2929528(4/29/2027), H2938646(5/12/2027). K05-02887/00884450285923/H2918527(4/29/2027), H2925313(4/29/2027), H2934862(5/12/2027). K05-03069A/00884450461440/H2938301(3/31/2027). K05-03095B/00884450639429/H2925319(4/22/2027), H2938649(5/12/2027). K05-03112/00884450404492/H2938650(5/12/2027). K05-03124/00884450432631/H2934820(5/5/2027), H2938651(5/12/2027), H2978212(6/3/2027). K05-03150/00884450480045/H2925320(4/22/2027). K05-50037G/0088445045609/H2925266(4/29/2027), H2934824(5/5/2027), H2938652(5/12/2027).

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

device · product 8 of 10

basixSKY Inflation Device, REF: SKY1802

Z-0071-2025
Recall number
Z-0071-2025
Initiated
August 19, 2024
Classification
Class II
Status
Ongoing
Quantity
70

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Code information

REF/UDI-DI/Lot(Expiration): SKY1802/00884450822500/H2925228(11/30/2026), H2934728(11/30/2026).

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

device · product 9 of 10

basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C

Z-0072-2025
Recall number
Z-0072-2025
Initiated
August 19, 2024
Classification
Class II
Status
Ongoing
Quantity
16,439

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Code information

REF/UDI-DI/Lot(Expiration): IN8130/JPC/00884450621073/H2929530(4/29/2027). IN8152/C/00884450621301/H2925219(4/22/2027), H2929412(4/29/2027), H2938005(5/12/2027), H2938006(5/12/2027), H2943498(5/19/2027), H2943499(5/19/2027), H2972593(5/26/2027), H2972594(5/26/2027), H2978092(6/3/2027). IN8302/C/00884450621325/H2925221(4/22/2027). IN8352/C/00884450621349/H2934719(5/5/2027). IN8802/C/00884450621417/H2925222(4/22/2027), H2934720(5/12/2027), H2943517(5/19/2027), H2972598(5/26/2027). IN8130/C/00884450621059/H2925215(4/22/2027), H2929410(4/29/2027), H2934714(5/5/2027), H2937998(5/12/2027), H2938000(5/12/2027), H2943487(5/19/2027). IN8130/C/00884450621059/H2972590(5/26/2027), H2978089(6/3/2027), H2978090(6/3/2027), H2978091(6/3/2027), H2989571(6/17/2027).

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

device · product 10 of 10

StabiliT TOUCH Syringe, REF: IN8VCF/B

Z-0073-2025
Recall number
Z-0073-2025
Initiated
August 19, 2024
Classification
Class II
Status
Ongoing
Quantity
202

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Code information

REF/UDI-DI/Lot(Expiration): IN8VCF/B/00884450662144/H2918440(5/31/2027), H2938015(7/26/2027).

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.