Every recall we track for Exact Medical Manufacturing, Inc. — 18 in all — plus the complaints and injury reports the public filed about them.
Exact Medical recalls ultrasonic transducer covers with item ID SH22 due to lack of 510k clearance for medical use. Affected units include specific lot numbers from 2008-2012.
Exact Medical recalls 6" x 96" ultrasonic transducer covers with no 510k clearance for surgical use. Affected items include specific lot numbers.
Exact Medical recalls 6" x 48" Elastic Poly Probe Covers due to lack of 510k clearance for surgical use. Affected items include specific lot numbers and item IDs. Consumers should contact Exact Medical for details.
Exact Medical recalls 6"x96" poly ultrasonic transducer covers with specific lot numbers due to lack of 510k clearance for medical use. Consumers should check their product details.
Exact Medical recalls PU and Elastic Blue Bands (6" x 48" with hole) due to lack of 510k clearance for body openings. Affected items have specific lot numbers.
Exact Medical recalls Transducer Cover 15x147cm kits due to lack of FDA 510(k) approval for use in natural or surgical body openings. Affected items include specific lot numbers from 2003-2011.
Exact Medical recalls 6" x 96" Elastic Poly Probe Cover (Item ID A-AU-0853NA) due to lack of 510k clearance for body use. Affected units include specific lot numbers from 2003-2012. No remedy provided in recall notice.
Exact Medical recalls Probe Cover 6"x48" Ultrasonic Transducer Cover (Item ID SH29) due to lack of 510k clearance for medical use. Affected units include specific lot numbers from 2009-2011.
Exact Medical Manufacturing recalls Hays Innovation Ultrasound Probe Cover Kit (HS2000HL) due to lack of FDA 510(k) clearance for surgical use. Affected units sold with lot numbers 2005E091.
Exact Medical recalls Ultrasonic Transducer Cover (Item ID E6360) due to lack of 510k clearance for medical use. Affected units sold with lot number 2003E691.
Exact Medical recalls Lite poly ultrasonic probe covers with specific lot numbers due to lack of FDA approval for use in natural or surgical body openings. Consumers should check their product details.
Exact Medical recalls bulk ultrasonic transducer covers due to lack of 510k clearance for body use. Affected items have specific lot numbers. Consumers should contact Exact Medical for details.
Exact Medical recalls 6"x96" Ultrasonic Transducer Covers (Item ID 1006: 2002E015, 2011E316) due to lack of 510k clearance for body openings. No remedy specified in recall notice.
Exact Medical recalls 6" x 96" ultrasonic transducer covers with item ID E6443N due to lack of 510k clearance for medical use. Affected units include specific lot numbers.
Exact Medical recalls 11 lot numbers of 6" x 48" ultrasonic transducer covers due to lack of FDA approval for use in natural or surgical body openings. Consumers should check item ID and lot numbers listed.
Exact Medical recalls ultrasonic transducer covers due to lack of 510k clearance for medical use. Affected items have specific lot numbers and item IDs.
Exact Medical recalls 6" x 48" Elastic Poly Probe Cover (Item ID: A-AU-0852NA) due to lack of 510k clearance for medical use. Affected units include specific lot numbers.
Exact Medical recalls Hays Ultrasound kit H1000SE (lot 2005E090, 2006E495) due to lack of FDA 510(k) clearance for medical use. Consumers should not use this device for body openings.
