Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 142 of 548
FDA Drug Moderate Sep 21, 2022
TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
FDA Drug Moderate Sep 21, 2022
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
FDA Drug Moderate Sep 21, 2022
L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
FDA Drug Moderate Sep 21, 2022
TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
FDA Drug Moderate Sep 21, 2022
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
FDA Devices Moderate Sep 21, 2022
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
ICU Medical, Inc.
FDA Devices Moderate Sep 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter position…
Cook Incorporated
FDA Devices Low Sep 21, 2022
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Who…
Microbiologics Inc
FDA Devices Moderate Sep 21, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMA…
Exactech, Inc.
FDA Devices Moderate Sep 21, 2022
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory…
ICU Medical, Inc.
FDA Devices Moderate Sep 21, 2022
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Sep 21, 2022
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and e…
Cook Incorporated
FDA Devices Moderate Sep 21, 2022
ZAP-X Radiosurgery System
Zap Surgical Systems
FDA Devices Moderate Sep 21, 2022
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and e…
Cook Incorporated
FDA Devices Moderate Sep 21, 2022
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
ICU Medical, Inc.
FDA Devices Moderate Sep 21, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 …
Exactech, Inc.
FDA Devices Moderate Sep 21, 2022
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
ICU Medical, Inc.
FDA Devices Moderate Sep 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter position…
Cook Incorporated
FDA Devices Moderate Sep 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positio…
Cook Incorporated
FDA Devices Moderate Sep 21, 2022
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be u…
Isopure Corp
FDA Devices Moderate Sep 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positionin…
Cook Incorporated
FDA Devices Moderate Sep 21, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; …
Exactech, Inc.
FDA Devices Low Sep 21, 2022
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack desi…
Steris Corporation Hopkins Facility
FDA Devices Moderate Sep 21, 2022
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
ICU Medical, Inc.
FDA Devices Moderate Sep 21, 2022
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Technomed Europe
FDA Devices Moderate Sep 21, 2022
Surpria 64: Software Version V3.11, V3.22
FUJIFILM Healthcare Americas Corporation
FDA Devices Moderate Sep 21, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LIN…
Exactech, Inc.
FDA Devices Moderate Sep 21, 2022
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
Carwild Corporation
FDA Devices Moderate Sep 21, 2022
iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chambe…
Alcor Scientific, Inc.
FDA Devices Low Sep 21, 2022
BIOPHEN UFH Control Plasma
Aniara Diagnostica LLC
FDA Devices Moderate Sep 21, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-5…
Exactech, Inc.
FDA Devices Moderate Sep 21, 2022
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and ex…
Cook Incorporated
FDA Devices Low Sep 21, 2022
PTS Panels CHOL+GLU Test Strips (REF 1765)
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
FDA Devices Critical Sep 21, 2022
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Baxter Healthcare Corporation
FDA Devices Moderate Sep 21, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-…
Exactech, Inc.
FDA Devices Moderate Sep 21, 2022
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FUJIFILM Healthcare Americas Corporation
FDA Devices Moderate Sep 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning…
Cook Incorporated
FDA Devices Moderate Sep 21, 2022
QIAcube Connect MDx, Model No. 9003070
Qiagen Sciences LLC
FDA Devices Moderate Sep 21, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106…
Exactech, Inc.
FDA Devices Moderate Sep 21, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH…
Exactech, Inc.
FDA Devices Moderate Sep 21, 2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positio…
Cook Incorporated
FDA Devices Moderate Sep 14, 2022
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG S…
ICU Medical, Inc.
FDA Devices Moderate Sep 14, 2022
Various Angiography packs/trays
American Contract Systems, Inc.
FDA Devices Moderate Sep 14, 2022
Breast Abdominoplasty Pack
American Contract Systems, Inc.
FDA Devices Moderate Sep 14, 2022
Various C-section packs
American Contract Systems, Inc.
FDA Devices Moderate Sep 14, 2022
Various convenience packs
American Contract Systems, Inc.
FDA Devices Moderate Sep 14, 2022
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Stradis Healthcare
FDA Devices Critical Sep 14, 2022
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insu…
Philips Respironics, Inc.
FDA Devices Moderate Sep 14, 2022
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Datascope Corporation
FDA Devices Moderate Sep 14, 2022
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Saranas, Inc.