PlainRecalls

Medical Devices Recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

27,372 recalls · Page 202 of 548

FDA Devices Moderate Oct 14, 2020

DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Oct 14, 2020

BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ

Biomet 3i, LLC

FDA Devices Moderate Oct 14, 2020

VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

Luminex Corporation

FDA Devices Moderate Oct 14, 2020

1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification …

AB ULAX

FDA Devices Moderate Oct 14, 2020

ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of …

Medline Industries Inc

FDA Devices Moderate Oct 14, 2020

BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001

Roche Diagnostics Operations, Inc.

FDA Drug Moderate Oct 7, 2020

blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 7.5 fl …

4e Brands North America, Llc

FDA Devices Moderate Oct 7, 2020

Pacific Xtreme (PTCA Balloon Dilation Catheter)

ev3 Inc.

FDA Devices Moderate Oct 7, 2020

First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B

Ameditech Inc

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588 - Produ…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ult…

ESAOTE S.P.A

FDA Devices Moderate Oct 7, 2020

Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD30…

Ameditech Inc

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for u…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25 Taper, Product Number: CV3100, UDI: 20884521150901 - Product Usage…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - Product Usage: indicated for use …

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - Product Usage: indicated for use in s…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 …

Ameditech Inc

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595 - Product Usage: indicated for use i…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut …

Ameditech Inc

FDA Devices Moderate Oct 7, 2020

TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, N…

Ameditech Inc

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper, Product Number: CV3110, UDI: 20884521150918 - Product Usage…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have appl…

Covidien, LP

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicated for u…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - Product Usage: indicated for u…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.

Cardinal Health 200, LLC

FDA Devices Moderate Oct 7, 2020

Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designe…

Olympus Corporation of the Americas

FDA Devices Moderate Oct 7, 2020

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

Exactech, Inc.

FDA Devices Moderate Oct 7, 2020

Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA u…

Covidien, LP

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV2279, UDI: 20884521151632 - Product Usage: indicate…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, …

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - Product Usage: indicat…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product …

North American Rescue LLC.

FDA Devices Moderate Oct 7, 2020

Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in ab…

Covidien, LP

FDA Devices Moderate Oct 7, 2020

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.

Exactech, Inc.

FDA Devices Moderate Oct 7, 2020

Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150…

Ameditech Inc

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10, Product Number: SV32, UDI: 20884521153117 - Product Usage: indicated f…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: …

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

ProxiDiagnost N90

Philips North America, LLC

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10 Cutting, Product Number: SV4893, UDI: 20884521151717 - Product Usag…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 20884521177403 - Product Usage: indi…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B

Ameditech Inc

FDA Devices Moderate Oct 7, 2020

Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP 14-DRUG PANE…

Ameditech Inc

FDA Devices Moderate Oct 7, 2020

UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quant…

Beckman Coulter Inc.

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper, Product Number: CV417G, UDI: 20884521149370 - Product Usage: …

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100 Adul…

Ameditech Inc

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage:…

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - Product Usage: indicated for …

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(…

Ameditech Inc

FDA Devices Moderate Oct 7, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13 Cutting SV2298, UDI: 20884521151021 - Product Usage: indicated for …

Riverpoint Medical, LLC

FDA Devices Moderate Oct 7, 2020

First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B

Ameditech Inc