Device recall: Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
Class II FDA enforcement event 87958. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
No 510k for the product to be used in a natural or surgical opening to the body
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Exact Medical Manufacturing, Inc. started this device recall on 29 Apr 2021. The firm address in the FDA record is in Lancaster, NY. FDA put the recall in Class II. FDA event 87958 has 18 product records. The first FDA enforcement report date is 30 Jun 2021. The record gives the status Terminated, with the termination date 26 May 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Recalling firm
Exact Medical Manufacturing, Inc., Lancaster, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
18 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1907-2021 | Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA | 8800 units | Class II | Terminated | 30 Jun 2021 |
| Z-1908-2021 | Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA | 1600 units | Class II | Terminated | 30 Jun 2021 |
| Z-1909-2021 | 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA | 17545 units | Class II | Terminated | 30 Jun 2021 |
| Z-1910-2021 | 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA | 7920 units | Class II | Terminated | 30 Jun 2021 |
| Z-1911-2021 | Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N | 12650 units | Class II | Terminated | 30 Jun 2021 |
| Z-1912-2021 | 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N | 9680 units | Class II | Terminated | 30 Jun 2021 |
| Z-1913-2021 | Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N | 5621 units | Class II | Terminated | 30 Jun 2021 |
| Z-1914-2021 | Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N | 129600 units | Class II | Terminated | 30 Jun 2021 |
| Z-1915-2021 | Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 | 100600 units | Class II | Terminated | 30 Jun 2021 |
| Z-1916-2021 | Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360 | 500 units | Class II | Terminated | 30 Jun 2021 |
| Z-1917-2021 | Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N | 51300 units | Class II | Terminated | 30 Jun 2021 |
| Z-1918-2021 | Hays Ultrasound kit Item ID: H1000SE | 10020 units | Class II | Terminated | 30 Jun 2021 |
| Z-1919-2021 | Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL | 3000 units | Class II | Terminated | 30 Jun 2021 |
| Z-1920-2021 | Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17 | 78000 units | Class II | Terminated | 30 Jun 2021 |
| Z-1921-2021 | Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 | 33250 units | Class II | Terminated | 30 Jun 2021 |
| Z-1922-2021 | Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29 | 36000 | Class II | Terminated | 30 Jun 2021 |
| Z-1923-2021 | Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576 | 800 units | Class II | Terminated | 30 Jun 2021 |
| Z-1924-2021 | Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664 | 6000 units | Class II | Terminated | 30 Jun 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 18
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1907-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 87958. https://recallregister.com/fda/ii/87958/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
- What quantity of product is in FDA event 87958?
- The event has 18 product records. The first record gives this quantity:
8800 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.