Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 198 of 548
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-…
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-22
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
OriGen Biomedical, Inc.
FDA Devices Moderate Nov 11, 2020
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide ran…
GE Healthcare, LLC
FDA Devices Moderate Nov 11, 2020
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes …
3M Company - Health Care Business
FDA Devices Low Nov 11, 2020
3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and…
Synthes (USA) Products LLC
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-…
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-32
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-…
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-806…
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-22
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 61 mm Number: 00-8065-958-32
Zimmer Biomet, Inc.
FDA Devices Low Nov 11, 2020
SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lu…
Synthes (USA) Products LLC
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-28
Zimmer Biomet, Inc.
FDA Devices Critical Nov 11, 2020
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To ass…
Cook Inc.
FDA Devices Moderate Nov 11, 2020
Flow Sensor Service Part, Catalog 2096513-001-S
GE Healthcare, LLC
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-…
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-…
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 53 mm Number: 00-8065-950-32
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-28
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-22
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-28
Zimmer Biomet, Inc.
FDA Devices Low Nov 11, 2020
SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lu…
Synthes (USA) Products LLC
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-…
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 49 mm Number: 00-8065-946-32
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-…
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 11, 2020
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-…
Zimmer Biomet, Inc.
FDA Devices Moderate Nov 4, 2020
5.5MM Arthrogarde Hip Access Cannula
Smith & Nephew, Inc.
FDA Devices Moderate Nov 4, 2020
CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number …
CME America LLC
FDA Devices Moderate Nov 4, 2020
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for mul…
Battelle Memorial Institute
FDA Devices Moderate Nov 4, 2020
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood samplin…
Becton Dickinson & Company
FDA Devices Moderate Nov 4, 2020
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to…
Philips North America, LLC
FDA Devices Moderate Nov 4, 2020
Merge LIS
Merge Healthcare, Inc.
FDA Devices Moderate Nov 4, 2020
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Pentax of America Inc
FDA Devices Moderate Nov 4, 2020
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within…
Microbiologics Inc
FDA Devices Moderate Nov 4, 2020
Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP…
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Nov 4, 2020
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model …
Intuitive Surgical, Inc.
FDA Devices Moderate Nov 4, 2020
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular …
GE Healthcare, LLC
FDA Devices Moderate Nov 4, 2020
Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN …
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Nov 4, 2020
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Exactech, Inc.
FDA Devices Moderate Nov 4, 2020
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
W L Gore & Associates, Inc.
FDA Devices Moderate Nov 4, 2020
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch scree…
Boston Scientific Corporation
FDA Food Critical Oct 28, 2020
The Spice Hunter Pumpkin Pie Spice 1.8 oz. Jar UPC 8105701850 Case UPC 40081057018505
Sauer Brands Inc - SLO
FDA Devices Moderate Oct 28, 2020
APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619083929(17…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 mul…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mec…
Bien-Air Surgery Sa
FDA Devices Moderate Oct 28, 2020
Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053189(17)2…
ICU Medical, Inc.