Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Deroyal Industries Inc
DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick R...
Medical Devices·36 affected·Jul 15, 2022
High RiskFDA
Ge Healthcare, Llc
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Vi...
Medical Devices·1,690 affected·Jul 15, 2022
High RiskFDA
Baxter Healthcare Corporation
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to co...
Medical Devices·448,960 affected·Jul 14, 2022
High RiskFDA
Aesculap Implant Systems Llc
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Medical Devices·5 affected·Jul 14, 2022
High RiskFDA
Philips Ultrasound, Llc
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232,...
Medical Devices·1,721 affected·Jul 14, 2022
High RiskFDA
Biomerieux, Inc.
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
Medical Devices·0 affected·Jul 13, 2022
High RiskFDA
Fujifilm Healthcare Americas Corporation
Surpria 64: Software Version V3.11, V3.22
Medical Devices·16 affected·Jul 12, 2022
High RiskFDA
Fujifilm Healthcare Americas Corporation
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Medical Devices·46 affected·Jul 12, 2022
High RiskFDA
Wissner-bosserhoff Gmbh
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Medical Devices·77 affected·Jul 11, 2022
High RiskFDA
Oculus Optikgeraete Gmbh
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Medical Devices·92 affected·Jul 8, 2022
High RiskFDA
Olympus Corporation Of The Americas
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Medical Devices·2 affected·Jul 7, 2022
High RiskFDA
Oxford Immunotec Ltd
T-Cell Xtend REF TTK.610 US
Medical Devices·47 affected·Jul 7, 2022
High RiskFDA
Oxford Immunotec Ltd
T-SPOT.TB REF TB.300 US
Medical Devices·81 affected·Jul 7, 2022
High RiskFDA
Zap Surgical Systems
ZAP-X Radiosurgery System
Medical Devices·8 affected·Jul 5, 2022
High RiskFDA
Medicina Uk Ltd
Medicina Oral Tip Syringe 0.5ml Code: OT005
Medical Devices·120 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
Medical Devices·9 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina Oral Tip Syringe 2.5ml Code: OT25
Medical Devices·20 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
Medical Devices·1 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina Reusable Oral syringe 5ml Code: OTH05
Medical Devices·26 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina Oral Tip Syringe 1ml Code: OT01
Medical Devices·29 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina Reusable Oral syringe 2.5ml Code: OTH25
Medical Devices·20 affected·Jul 4, 2022
High RiskFDA
Intuitive Surgical, Inc.
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, ...
Medical Devices·62,895 affected·Jul 1, 2022
High RiskFDA
Micro Therapeutics, Inc.
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Medical Devices·8 affected·Jun 30, 2022
High RiskFDA
Trinity Sterile, Inc.
Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
Medical Devices·5 affected·Jun 29, 2022
High RiskFDA
Trinity Sterile, Inc.
Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
Medical Devices·4,169 affected·Jun 29, 2022
High RiskFDA
Orthopediatrics Corp
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Medical Devices·640 affected·Jun 29, 2022
High RiskFDA
Trinity Sterile, Inc.
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
Medical Devices·2,512 affected·Jun 29, 2022
RecallFDA
Aniara Diagnostica Llc
BIOPHEN UFH Control Plasma
Medical Devices·13 affected·Jun 28, 2022
High RiskFDA
Icu Medical, Inc.
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,Che...
Medical Devices·454,635 affected·Jun 27, 2022
High RiskFDA
Smith & Nephew, Inc.
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Prod...
Medical Devices·31 affected·Jun 27, 2022
High RiskFDA
Icu Medical, Inc.
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20...
Medical Devices·358,975 affected·Jun 27, 2022
CriticalFDA
Davol, Inc.
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Medical Devices·9,420 affected·Jun 27, 2022
High RiskFDA
Ge Healthcare, Llc
SIGNA Premier magnetic resonance scanner, model 5748519.
Medical Devices·52 affected·Jun 24, 2022
High RiskFDA
Lumiradx
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Medical Devices·99 affected·Jun 24, 2022
High RiskFDA
Baxter Healthcare Corporation
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
Medical Devices·200 affected·Jun 24, 2022
High RiskFDA
Baxter Healthcare Corporation
Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
Medical Devices·8 affected·Jun 24, 2022
High RiskFDA
Neotract Inc
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Medical Devices·18,722 affected·Jun 24, 2022
High RiskFDA
Baxter Healthcare Corporation
Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
Medical Devices·9 affected·Jun 24, 2022
High RiskFDA
Family Dollar Stores, Llc.
KY JELLY LUBRICANT 2 FL OZ, SKU 901443
Medical Devices·5 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
FIRST RESPONSE 2 CT, SKU 902343
Medical Devices·77 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU
Medical Devices·419 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531
Medical Devices·733 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
Medical Devices·128 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
DENTEMP ONE STEP .077OZ, SKU 902139
Medical Devices·3,122 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
Medical Devices·47 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
GS SALINE SOLUTION 12FL OZ, SKU 902274
Medical Devices·21 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
Medical Devices·1,555 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT, SKU 906131
Medical Devices·34 affected·Jun 23, 2022