Exact Medical Manufacturing, Inc. FDA Record
Exact Medical Manufacturing, Inc. has 18 FDA recalls, 4 inspections, 9 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Exact Medical Manufacturing, Inc." is on file.
- Latest recall
- Z-1914-2021 · Class II · Apr 29, 2021
- Latest inspection
- Jul 12, 2023 · NAI
- Latest 510(k)
- May 12, 2023
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 18 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 9 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 4 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 18 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1914-2021 | Class II | Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N | Apr 29, 2021 |
| Z-1909-2021 | Class II | 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA | Apr 29, 2021 |
| Z-1918-2021 | Class II | Hays Ultrasound kit Item ID: H1000SE | Apr 29, 2021 |
| Z-1922-2021 | Class II | Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29 | Apr 29, 2021 |
| Z-1908-2021 | Class II | Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID… | Apr 29, 2021 |
| Z-1917-2021 | Class II | Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N | Apr 29, 2021 |
| Z-1913-2021 | Class II | Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N | Apr 29, 2021 |
| Z-1911-2021 | Class II | Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID… | Apr 29, 2021 |
| Z-1907-2021 | Class II | Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile… | Apr 29, 2021 |
| Z-1915-2021 | Class II | Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 | Apr 29, 2021 |
| Z-1923-2021 | Class II | Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576 | Apr 29, 2021 |
| Z-1919-2021 | Class II | Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL | Apr 29, 2021 |
| Z-1921-2021 | Class II | Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 | Apr 29, 2021 |
| Z-1910-2021 | Class II | 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item… | Apr 29, 2021 |
| Z-1920-2021 | Class II | Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17 | Apr 29, 2021 |
| Z-1916-2021 | Class II | Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID… | Apr 29, 2021 |
| Z-1912-2021 | Class II | 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item… | Apr 29, 2021 |
| Z-1924-2021 | Class II | Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664 | Apr 29, 2021 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 12, 2023 | Lancaster, NY | Devices | No Action Indicated (NAI) | 3008011779 |
| Mar 11, 2021 | Lancaster, NY | Devices | Voluntary Action Indicated (VAI) | 3008011779 |
| May 2, 2019 | Changzhou, China | Devices | No Action Indicated (NAI) | 3013443304 |
| Nov 21, 2017 | Lancaster, NY | Devices | No Action Indicated (NAI) | 3008011779 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008011779 | Lancaster, NY | 3 | Jul 12, 2023 |
| FEI 3013443304 | Changzhou, China | 1 | May 2, 2019 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K222460 | Intraoperative Ultrasound Probe Cover | May 12, 2023 |
| K211969 | EMM Ultrasonic Transducer Cover | Aug 13, 2021 |
| K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | Feb 14, 2013 |
| K120045 | EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV | Jun 12, 2012 |
| K111535 | EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER | Aug 26, 2011 |
| K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE… | Oct 4, 2010 |
| K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | Sep 20, 2010 |
| K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | Sep 20, 2010 |
| K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL | Sep 3, 2010 |
Exact Medical Manufacturing, Inc. and the FDA: common questions
Has Exact Medical Manufacturing, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Exact Medical Manufacturing, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Exact Medical Manufacturing, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Exact Medical Manufacturing, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Exact Medical Manufacturing, Inc.?
The most recent FDA inspection on file ended Jul 12, 2023 at Lancaster, NY and was classified NAI. FDA has 4 inspections of Exact Medical Manufacturing, Inc. on file.
Has Exact Medical Manufacturing, Inc. had an FDA recall?
Yes. Exact Medical Manufacturing, Inc. has 18 FDA recalls on record. The most recent started Apr 29, 2021.
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