Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - BIOMET Orthopedics - Class 2 Recall
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2020 Category: Medical Devices Source Type: alerts

Bard Peripheral Vascular Inc - WAVELINQ 4F EndoAVF System - Class 2 Recall
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 3, 2020 Category: Medical Devices Source Type: alerts

Ra Medical Systems, Inc. - Pharos Ex308 Excimer Laser System - Class 2 Recall
Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region of the electromagnetic spectrum. The UV radiation falls within the range of ultraviolet B (UVB), which is used to treat photo-responsive skin disorders. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Contour VL Ureteral Stent Set - Class 2 Recall
Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Sensor Nitinol Wire with Hydrophilic Tip .035 - Class 2 Recall
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Sensor Nitinol Wire with Hydrophilic Tip - Class 2 Recall
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Stretch VL Ureteral Stent Set - Class 2 Recall
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Sensor Nitinol Wire with Hydrophilic Tip - Class 2 Recall
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Percuflex Plus Ureteral Stent Set - Class 2 Recall
Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Stretch VL Ureteral Stent Set - Class 2 Recall
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Percuflex Plus Ureteral Stent Set - Class 2 Recall
Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Polaris Ultra Ureteral Stent Set - Class 2 Recall
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Sensor Nitinol Wire with Hydrophilic Tip - Class 2 Recall
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Percuflex Plus Ureteral Stent Set - Class 2 Recall
Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific - Stretch VL Ureteral Stent Set - Class 2 Recall
Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Qiagen Sciences LLC - AmniSure ROM Test - Class 2 Recall
AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box) (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Conformis, Inc. - iTotal Posterior Stabilized (PS) Knee Replacement System - Class 2 Recall
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Smith & Nephew, Inc. - NAVIO Soft Tissue Protector - Class 2 Recall
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Conformis, Inc. - iTotal Cruciate Retaining (CR) Knee Replacement System - Class 2 Recall
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Physio-Control, Inc. - LifePak 500 Automatic external Defibrillator - Class 2 Recall
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s electrocardiographic (ECG) rhythm and indicates whether it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Trilliant Surgical, LLC - HTR Implant System;Trilliant Surgical KWires - Class 2 Recall
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Merits Holdings Co. dba Merits Health Products, Inc. - Pilot - Class 2 Recall
Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Natus Manufacturing Limited - Olympic Brainz Monitor - Class 2 Recall
natus newborn care Olympic Brainz Monitor, REF OBM00002 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

LeMaitre Vascular, Inc. - LeMaitre 5F Plus Over the Wire Embolectomy Catheter - Class 1 Recall
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts

Karl Storz Endoscopy - Video Laryngoscope - Class 2 Recall
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 1, 2020 Category: Medical Devices Source Type: alerts

Haemonetics Corporation - TEG Manager, Accessory to Thrombelastograph Coagulation Analyzer TEG5000 Series - Class 2 Recall
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 1, 2020 Category: Medical Devices Source Type: alerts

Stryker Neurovascular - AXS Vecta 71 Aspiration Catheter - Class 2 Recall
Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-125, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459227(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-132, Use By 2021-11-29, Rx Only,...
Source: Medical Device Recalls - April 1, 2020 Category: Medical Devices Source Type: alerts