FDA Devices Verify with FDA Devices → Moderate Class II Ongoing

Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 30-0025 35.0mm Acutrak 2¿ - 5.5 Screw 30-0025-S 35.0mm Acutrak 2¿ - 5.5 Screw 30-0027 40.0mm Acutrak 2¿ - 5.5 Screw 30-0027-S 40.0mm Acutrak 2¿ - 5.5 Screw 30-0029 45.0mm Acutrak 2¿ - 5.5 Screw 30-0029-S 45.0mm Acutrak 2¿ - 5.5 Screw 30-0031 50.0mm Acutrak 2¿ - 5.5 Screw 30-0031-S 50.0mm Ac

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on January 4, 2023. Severity: Moderate. Recall number: Z-0768-2023.

Q: Where was the recalled product distributed?

Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, 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, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0768-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Reviewed byPlainRecalls Editorial, Product Recalls Editorial Team · June 9, 2026

Reported: January 4, 2023 Initiated: November 29, 2022 #Z-0768-2023 1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048) units

Acumed LLC issued this FDA Devices recall on January 4, 2023. Classified as Moderate severity (Class II). Approximately 1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048) units are affected. The recall was issued because: Distribution without Pre-Market Clearance. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-0768-2023) was formally reported on January 4, 2023, with the manufacturer initiating the action on November 29, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Acumed LLC is listed as the recalling firm, operating out of Hillsboro, OR. Federal records indicate 1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Distribution without Pre-Market Clearance Distribution data in the federal record shows the product reached: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, 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,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity

Moderate

Units Affected

1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048)

Related Recalls

6 from same agency

Product Description

Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 30-0025 35.0mm Acutrak 2¿ - 5.5 Screw 30-0025-S 35.0mm Acutrak 2¿ - 5.5 Screw 30-0027 40.0mm Acutrak 2¿ - 5.5 Screw 30-0027-S 40.0mm Acutrak 2¿ - 5.5 Screw 30-0029 45.0mm Acutrak 2¿ - 5.5 Screw 30-0029-S 45.0mm Acutrak 2¿ - 5.5 Screw 30-0031 50.0mm Acutrak 2¿ - 5.5 Screw 30-0031-S 50.0mm Acutrak 2¿ - 5.5 Screw 30-0084 55.0mm Acutrak 2¿ - 5.5 Screw 30-0084-S 55.0mm Acutrak 2¿ - 5.5 Screw 30-0085 60.0mm Acutrak 2¿ - 5.5 Screw 30-0085-S 60.0mm Acutrak 2¿ - 5.5 Screw 30-0620 20.0mm Acutrak 2¿ - 4.7 Screw 30-0620-S 20.0mm Acutrak 2¿ - 4.7 Screw 30-0622 22.0mm Acutrak 2¿ - 4.7 Screw 30-0622-S 22.0mm Acutrak 2¿ - 4.7 Screw 30-0624 24.0mm Acutrak 2¿ - 4.7 Screw 30-0624-S 24.0mm Acutrak 2¿ - 4.7 Screw 30-0626 26.0mm Acutrak 2¿ - 4.7 Screw 30-0626-S 26.0mm Acutrak 2¿ - 4.7 Screw 30-0628 28.0mm Acutrak 2¿ - 4.7 Screw 30-0628-S 28.0mm Acutrak 2¿ - 4.7 Screw 30-0630 30.0mm Acutrak 2¿ - 4.7 Screw 30-0630-S 30.0mm Acutrak 2¿ - 4.7 Screw 30-0635 35.0mm Acutrak 2¿ - 4.7 Screw 30-0635-S 35.0mm Acutrak 2¿ - 4.7 Screw 30-0640 40.0mm Acutrak 2¿ - 4.7 Screw 30-0640-S 40.0mm Acutrak 2¿ - 4.7 Screw 30-0645 45.0mm Acutrak 2¿ - 4.7 Screw 30-0645-S 45.0mm Acutrak 2¿ - 4.7 Screw 30-0650 50.0mm Acutrak 2¿ - 4.7 Screw 30-0650-S 50.0mm Acutrak 2¿ - 4.7 Screw 30-0740 40.0mm Acutrak 2¿ - 7.5 Screw 30-0740-S 40.0mm Acutrak 2¿ - 7.5 Screw 30-0745 45.0mm Acutrak 2¿ - 7.5 Screw 30-0745-S 45.0mm Acutrak 2¿ - 7.5 Screw 30-0750 50.0mm Acutrak 2¿ - 7.5 Screw 30-0750-S 50.0mm Acutrak 2¿ - 7.5 Screw 30-0755 55.0mm Acutrak 2¿ - 7.5 Screw 30-0755-S 55.0mm Acutrak 2¿ - 7.5 Screw 30-0760 60.0mm Acutrak 2¿ - 7.5 Screw 30-0760-S 60.0mm Acutrak 2¿ - 7.5 Screw 30-0770 70.0mm Acutrak 2¿ - 7.5 Screw 30-0770-S 70.0mm Acutrak 2¿ - 7.5 Screw 30-0775 75.0mm Acutrak 2¿ - 7.5 Screw 30-0775-S 75.0mm Acutrak 2¿ - 7.5 Screw 30-0780 80.0mm Acutrak 2¿ - 7.5 Screw 30-0780-S 80.0mm Acutrak 2¿ - 7.5 Screw 30-0785 85.0mm Acutrak 2¿ - 7.5 Screw 30-0785-S 85.0mm Acutrak 2¿ - 7.5 Screw 30-0790 90.0mm Acutrak 2¿ - 7.5 Screw 30-0790-S 90.0mm Acutrak 2¿ - 7.5 Screw 30-0795 95.0mm Acutrak 2¿ - 7.5 Screw 30-0795-S 95.0mm Acutrak 2¿ - 7.5 Screw 30-0800 100.0mm Acutrak 2¿ - 7.5 Screw 30-0800-S 100.0mm Acutrak 2¿ - 7.5 Screw 30-0805 105.0mm Acutrak 2¿ - 7.5 Screw 30-0805-S 105.0mm Acutrak 2¿ - 7.5 Screw 30-0810 110.0mm Acutrak 2¿ - 7.5 Screw 30-0810-S 110.0mm Acutrak 2¿ - 7.5 Screw 30-0815 115.0mm Acutrak 2¿ - 7.5 Screw 30-0815-S 115.0mm Acutrak 2¿ - 7.5 Screw 30-0820 120.0mm Acutrak 2¿ - 7.5 Screw Micro Acutrak 2 Part Number/Part Description: AT2-C08 through AT2-S34-S 8.0-34.0mm, Micro Acutrak 2¿ Bone Screw

Reason for Recall

Distribution without Pre-Market Clearance

Details

Recalling Firm: Acumed LLC
Units Affected: 1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048)
Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, 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, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA.
Location: Hillsboro, OR

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0768-2023
Date reported	January 4, 2023
Date initiated	November 29, 2022
Recalling firm	Acumed LLC
Units affected	1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048)
Distribution	Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, 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, RI, SC, SD, TN,…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048) units affected — million-unit bracket.

Regional (<10K units) —

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Distribution without Pre-Market Clearance

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on January 4, 2023. Severity: Moderate. Recall number: Z-0768-2023.

Where was the recalled product distributed? ▼

Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, 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, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0768-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Recall Guides

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How the US Recall System Works

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Understanding Recall Severity Classes

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Most Recalled Product Categories

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Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Related Safety Data

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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Accessed 2026-06-09 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).