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U.S. Department of Health and Human Services

Medical Device Recalls

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Given Imaging Bravo® pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of g... 2 May-06-2016 Covidien LLC
Given Imaging Bravo®® pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of... 2 May-06-2016 Covidien LLC
NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation 2 May-06-2016 Novarad Corporation
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into ... 2 May-06-2016 Atlas Spine, Inc.
TLC® Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY ... 2 May-05-2016 Applied Medical Technology Inc
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgica... 2 May-05-2016 Applied Medical Technology Inc
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE ... 2 May-05-2016 Applied Medical Technology Inc
TLC® Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. P... 2 May-05-2016 Applied Medical Technology Inc
Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjus... 2 May-04-2016 Ferno-Washington Inc
Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable l... 2 May-04-2016 Ferno-Washington Inc

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