Exact Medical Manufacturing, Inc.

Complete recall history across all FDA and CPSC categories — 18 total recalls

Exact Medical Manufacturing, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (18)

FDA medical device enforcement actions by Exact Medical Manufacturing, Inc.

Date Product Reason Class
Apr 29, 2021 Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Co... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Tr... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover ... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17 No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Tra... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29 No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover I... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Trans... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover I... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cove... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover ... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover ... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cove... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-08... No 510k for the product to be used in a natural or surgical opening to the body Class II
Apr 29, 2021 Hays Ultrasound kit Item ID: H1000SE No 510k for the product to be used in a natural or surgical opening to the body Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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