Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Ethicon, Inc.
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approxima...
Medical Devices·1,032 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Encore Medical, Lp
EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous ...
Medical Devices·12 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applica...
Medical Devices·281 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Aesculap Implant Systems Llc
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
Medical Devices·24 affected·Sep 8, 2020
High RiskFDA
Ge Healthcare, Llc
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolutio...
Medical Devices·30 affected·Sep 8, 2020
High RiskFDA
Aesculap Implant Systems Llc
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
Medical Devices·27 affected·Sep 8, 2020
High RiskFDA
Aesculap Implant Systems Llc
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
Medical Devices·20 affected·Sep 8, 2020
High RiskFDA
Aesculap Implant Systems Llc
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
Medical Devices·23 affected·Sep 8, 2020
RecallFDA
Devicor Medical Products Inc
Neoprobe GDS Control Unit, Model Number NPCU3
Medical Devices·49 affected·Sep 7, 2020
High RiskFDA
Biomet, Inc.
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Medical Devices·33 affected·Sep 4, 2020
High RiskFDA
Biomet, Inc.
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Medical Devices·4 affected·Sep 4, 2020
High RiskFDA
Biomet, Inc.
Biomet Regenerex Primary Taper Cap Item Number 141269
Medical Devices·62 affected·Sep 4, 2020
High RiskFDA
Allison Medical, Inc.
CarePoint 60 mL Syringe Without Needle, REF: 04-7560
Medical Devices·2,004 affected·Sep 3, 2020
High RiskFDA
Biomet, Inc.
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 1100104...
Medical Devices·48 affected·Sep 3, 2020
High RiskFDA
Gentian As
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012,...
Medical Devices·107 affected·Sep 2, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and ...
Medical Devices·15 affected·Sep 1, 2020
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3...
Medical Devices·231,250 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
Medical Devices·2,900 affected·Aug 31, 2020
High RiskFDA
Brainlab Ag
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: inten...
Medical Devices·271 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spir...
Medical Devices·19,850 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Dri...
Medical Devices·217,522 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Medical Devices·2 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
Medical Devices·325 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
Medical Devices·10 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip ...
Medical Devices·55,000 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
Medical Devices·9 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
Medical Devices·900 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
Medical Devices·35 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 ...
Medical Devices·4,790 affected·Aug 31, 2020
CriticalFDA
Roche Diagnostics Operations, Inc.
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
Medical Devices·257 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Mal...
Medical Devices·1,856,578 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx...
Medical Devices·37,000 affected·Aug 31, 2020
High RiskFDA
Biomet 3i, Llc
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
Medical Devices·7 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4....
Medical Devices·88,700 affected·Aug 31, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV mo...
Medical Devices·193 affected·Aug 31, 2020
RecallFDA
Roche Diagnostics Operations, Inc.
Albumin Gen.2, Catalog 05166861190
Medical Devices·11,963 affected·Aug 27, 2020