Ultrasonic Probe Cover Recalled for Missing FDA 510(k) Clearance
Exact Medical Manufacturing is recalling ultrasonic probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings. The 51,300 affected units were distributed across six U.S. states and Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a device intended for invasive use in natural or surgical body openings that was marketed without required FDA 510(k) clearance. Per the rubric, this qualifies as a risk-of-harm product where no injury has been reported, warranting a High severity classification.
Plain-English summary
Exact Medical Manufacturing, Inc. is recalling Probe Cover item E6443N (6" x 96" polyethylene with 3 elastic bands), an ultrasonic transducer cover. The product was marketed for use in natural or surgical body openings without the required FDA 510(k) clearance.
The 510(k) is the FDA's premarket notification required before a medical device can be legally marketed for a specific use. The product lacked this required clearance for its intended use.
The recall affects 51,300 units distributed to medical facilities in Florida, Montana, New York, Ohio, Georgia, and Puerto Rico. Affected lot numbers include: 1906E310, 1908E208, 1908E561, 1910E032, 1910E350, 1911E262, 1912E540, 2003E308, 2002E135, 2003E324, 2004E513, 2009E129, 2009E408, 2101E069, and 2011E404.
The recalled product
- Product
- Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- missing-fda-clearance
Distribution
Distributed in 5 states:
- FL
- GA
- MT
- NY
- OH
Related recalls
Same category
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27
- SevereSwan-Ganz Catheters Models 131F7 Through AIQSGF8 Recalled Nationwide
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27