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Found 12,723 results for "product recalls and alerts"

Safety AlertCanadaHealth Canada

DRESBE LED Christmas Headbands recalled due to potential injury hazard

Consumer product safety
Health CanadaGeneral Alert

DRESBE LED Christmas Headbands recalled due to potential injury hazard

Injury hazard

Apr 10, 2026Consumer product safety
Safety AlertCanadaHealth Canada

TJ Trading Co. Inc. products recalled due to missing mandatory hazard labelling

Consumer product safety
Health CanadaGeneral Alert

TJ Trading Co. Inc. products recalled due to missing mandatory hazard labelling

Labelling and packaging

Apr 10, 2026Consumer product safety
Safety AlertCanadaHealth Canada

Think twice before injecting peptides bought online: unauthorized products can seriously harm you

Communications and Public Affairs Branch
Health CanadaGeneral Alert

Think twice before injecting peptides bought online: unauthorized products can seriously harm you

Unauthorized product

Apr 9, 2026Communications and Public Affairs Branch
Safety AlertUSCPSC

Halloween Pumpkin Carving Kits Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by Besslly Store

Unknown Firm
Halloween Pumpkin Carving Kits Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by Besslly Store
CPSCGeneral Alert

Halloween Pumpkin Carving Kits Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by Besslly Store

The recalled carving kits violate the mandatory standard for consumer products with button cell and coin batteries because the button cell batteries in the tea lights can be accessed easily by children, posing an ingestion hazard. Additionally, the product and its packaging do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.

Apr 9, 2026
Safety AlertUSCPSC

ShymeryDirect LED Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries

Unknown Firm
ShymeryDirect LED Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries
CPSCGeneral Alert

ShymeryDirect LED Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries

The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain lithium coin batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the LED lights do not have the warnings required by Reese's Law. If coin batteries are swallowed, they can cause serious injuries, internal chemical burns and death.

Apr 9, 2026
Safety AlertCanadaHealth Canada

Rexall and Pro-Line chemical products recalled due to lack of child-resistant packaging

Consumer product safety
Health CanadaGeneral Alert

Rexall and Pro-Line chemical products recalled due to lack of child-resistant packaging

Labelling and packaging

Apr 9, 2026Consumer product safety
Safety AlertCanadaHealth Canada

BISSELL brand Steam Shot™ OmniReach™ and Steam Shot™ Omni Steam Cleaner attachments recalled due to burn hazard

Consumer product safety
Health CanadaGeneral Alert

BISSELL brand Steam Shot™ OmniReach™ and Steam Shot™ Omni Steam Cleaner attachments recalled due to burn hazard

Burn hazard

Apr 9, 2026Consumer product safety
Food & BeverageUSUSDA FSIS

FSIS Issues Public Health Alert for Beef and Pork Products Due to Misbranding and Undeclared Allergen

Sky Ranch Meat LLC
USDA FSISPublic Health A...

FSIS Issues Public Health Alert for Beef and Pork Products Due to Misbranding and Undeclared Allergen

Misbranding, Unreported Allergens

Apr 9, 2026Sky Ranch Meat LLC
Safety AlertUSCPSC

Easymake Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violates Mandatory Standard for Adult Portable Bed Rails; Imported by ZFZG-US

Zhongshan Yungu Daily Products, of China
Easymake Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violates Mandatory Standard for Adult Portable Bed Rails; Imported by ZFZG-US
CPSCGeneral Alert

Easymake Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violates Mandatory Standard for Adult Portable Bed Rails; Imported by ZFZG-US

The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.

Apr 9, 2026Zhongshan Yungu Daily Products, of China
Safety AlertCanadaHealth Canada

HEAD Alpine Ski Boots recalled due to injury hazard

Consumer product safety
Health CanadaGeneral Alert

HEAD Alpine Ski Boots recalled due to injury hazard

Injury hazard

Apr 9, 2026Consumer product safety
Safety AlertCanadaHealth Canada

Arbutus Farms Kitchen/Jade Fine Foods brand and Arbutus Foods brand products with cheese recalled due to Listeria monocytogenes

CFIA
Health CanadaClass 1

Arbutus Farms Kitchen/Jade Fine Foods brand and Arbutus Foods brand products with cheese recalled due to Listeria monocytogenes

Listeria

Apr 9, 2026CFIA
Safety AlertCanadaHealth Canada

Kollide Magnet Game recalled due to ingestion hazard

Consumer product safety
Health CanadaGeneral Alert

Kollide Magnet Game recalled due to ingestion hazard

Ingestion hazard

Apr 9, 2026Consumer product safety
Safety AlertCanadaHealth Canada

SCUBAPRO Monorail Weight Pockets recalled due to drowning hazard

Consumer product safety
Health CanadaGeneral Alert

SCUBAPRO Monorail Weight Pockets recalled due to drowning hazard

Drowning hazard

Apr 9, 2026Consumer product safety
Safety AlertUSCPSC

LED Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries; Sold on Amazon by Happiness Light

Unknown Firm
LED Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries; Sold on Amazon by Happiness Light
CPSCGeneral Alert

LED Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries; Sold on Amazon by Happiness Light

The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain lithium coin batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the LED lights do not have the warnings as required by Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

Apr 9, 2026
Medical DeviceUSFDA Devices

Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A

Intuitive Surgical, Inc.
FDA DevicesClass II

Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Apr 8, 2026Intuitive Surgical, Inc.
Medical DeviceUSFDA Devices

Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Intuitive Surgical, Inc.
FDA DevicesClass II

Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Apr 8, 2026Intuitive Surgical, Inc.
Medical DeviceUSFDA Devices

Vue Motion V12. Product Number: 1017979.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA DevicesClass II

Vue Motion V12. Product Number: 1017979.

Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

Apr 8, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceUSFDA Devices

Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A

Intuitive Surgical, Inc.
FDA DevicesClass II

Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Apr 8, 2026Intuitive Surgical, Inc.
Medical DeviceUSFDA Devices

2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

Synthes (USA) Products LLC
FDA DevicesClass II

2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

Apr 8, 2026Synthes (USA) Products LLC
PharmaceuticalUSFDA Drugs

Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-141-01; b) Walgreens, Eye Drops, Original Formula, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20073 6; c) Walgreens, Eye Drops, Original Formula, 2 Bottles, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20076 7; d) Kroger Sterile eye drops, Original, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 1110 38597 0; e) Sterile eye drops, Regular formula, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, UPC 3 66715 68324 3; f) CVP Sterile EYE DROPS, Distributed by: Salado Sales. Inc., Temple, TX 76503; UPC 7 61606 16500 3; g) Harris Teeter, Eye Drops, Original, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71302 5; h) H.E.B Original Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; i) Rugby tetrahydrozoline ophthalmic Solution, Distributed by: RUGBY LABORATORIES, IN 46268, NDC 0536-1217-94, j) Equaline, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 25110 6; k) Discount drug mart, EyeDrops ORIGINAL, Discount Drug Mart Food Fair, 211 Commerce Drive, Medina, OH 44256, UPC 0 93351 01156 3; L) LEADER Original Eye Drops, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0454-1; m) CAREone, DISTRIBUTED BY FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 41520-431-05; n) Circle K sterile eye drops, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; o) DG health Original Formula, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; p) Good Neighbor Pharmacy Eye Drops, Original Formula, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-075-05; q) TopCare health, Original Eye Drops, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; r) Best Choice, Eye Drops, ORIGINAL, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47011 3

K.C. Pharmaceuticals, Inc
FDA DrugsClass II

Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-141-01; b) Walgreens, Eye Drops, Original Formula, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20073 6; c) Walgreens, Eye Drops, Original Formula, 2 Bottles, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20076 7; d) Kroger Sterile eye drops, Original, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 1110 38597 0; e) Sterile eye drops, Regular formula, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, UPC 3 66715 68324 3; f) CVP Sterile EYE DROPS, Distributed by: Salado Sales. Inc., Temple, TX 76503; UPC 7 61606 16500 3; g) Harris Teeter, Eye Drops, Original, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71302 5; h) H.E.B Original Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; i) Rugby tetrahydrozoline ophthalmic Solution, Distributed by: RUGBY LABORATORIES, IN 46268, NDC 0536-1217-94, j) Equaline, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 25110 6; k) Discount drug mart, EyeDrops ORIGINAL, Discount Drug Mart Food Fair, 211 Commerce Drive, Medina, OH 44256, UPC 0 93351 01156 3; L) LEADER Original Eye Drops, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0454-1; m) CAREone, DISTRIBUTED BY FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 41520-431-05; n) Circle K sterile eye drops, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; o) DG health Original Formula, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; p) Good Neighbor Pharmacy Eye Drops, Original Formula, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-075-05; q) TopCare health, Original Eye Drops, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; r) Best Choice, Eye Drops, ORIGINAL, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47011 3

Lack of Assurance of Sterility

Apr 8, 2026K.C. Pharmaceuticals, Inc
Medical DeviceUSFDA Devices

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Olympus Corporation of the Americas
FDA DevicesClass II

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

Apr 8, 2026Olympus Corporation of the Americas
Medical DeviceUSFDA Devices

Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Intuitive Surgical, Inc.
FDA DevicesClass II

Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Apr 8, 2026Intuitive Surgical, Inc.
Medical DeviceUSFDA Devices

Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Intuitive Surgical, Inc.
FDA DevicesClass II

Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Apr 8, 2026Intuitive Surgical, Inc.
Medical DeviceUSFDA Devices

Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.

Ultradent Products, Inc.
FDA DevicesClass II

Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.

Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.

Apr 8, 2026Ultradent Products, Inc.
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