Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Nu...
Medical Devices·0 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
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
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Pentax Of America Inc
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Medical Devices·39 affected·Sep 22, 2020
High RiskFDA
Cardinal Health 200, Llc
Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the deliver...
Medical Devices·197,370 affected·Sep 22, 2020
High RiskFDA
Boston Scientific Corporation
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Medical Devices·8 affected·Sep 22, 2020
High RiskFDA
Cardinal Health 200, Llc
Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery...
Medical Devices·314,460 affected·Sep 22, 2020
High RiskFDA
Boston Scientific Corporation
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a...
Medical Devices·1 affected·Sep 22, 2020
High RiskFDA
Smith & Nephew, Inc.
5.5MM Arthrogarde Hip Access Cannula
Medical Devices·143 affected·Sep 21, 2020
CriticalFDA
Stryker Neurovascular
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 930...
Medical Devices·5,365 affected·Sep 21, 2020
High RiskFDA
Conformis, Inc.
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components ...
Medical Devices·2 affected·Sep 21, 2020
High RiskFDA
Ge Healthcare, Llc
Flow Sensor Service Part, Catalog 2089610-001-S
Medical Devices·4,794 affected·Sep 17, 2020
High RiskFDA
Genicon, Inc.
A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever...
Medical Devices·8,872 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Medical Devices·37 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
Flow Sensor Service Part, Catalog 2096513-001-S
Medical Devices·2 affected·Sep 17, 2020
High RiskFDA
Merit Medical Systems, Inc.
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)0088445...
Medical Devices·3,385,442 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450...
Medical Devices·159,396 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit...
Medical Devices·371,528 affected·Sep 16, 2020
High RiskFDA
Medline Industries Inc
Quick Release Gait Belt, 60
Medical Devices·13,500 affected·Sep 15, 2020
High RiskFDA
3m Company - Health Care Business
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50...
Medical Devices·10,145,050 affected·Sep 15, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits c...
Medical Devices·80 affected·Sep 14, 2020
High RiskFDA
Becton Dickinson & Company
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, b...
Medical Devices·72 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consi...
Medical Devices·80 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist o...
Medical Devices·20 affected·Sep 14, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Medical Devices·9,907 affected·Sep 12, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical e...
Medical Devices·1,120 affected·Sep 11, 2020
High RiskFDA
Skytron, Div. The Kmw Group, Inc
VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Mo...
Medical Devices·11 affected·Sep 11, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energ...
Medical Devices·1,120 affected·Sep 11, 2020
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-...
Medical Devices·143 affected·Sep 11, 2020
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or ex...
Medical Devices·1 affected·Sep 11, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive h...
Medical Devices·1,120 affected·Sep 11, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological application...
Medical Devices·6 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
Medical Devices·0 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
Medical Devices·0 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
Medical Devices·0 affected·Sep 9, 2020