Safety Recalls

15,271 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 5,951–6,000 of 15,271

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Medical Device Recall · June 20, 2025

  Intersurgical Inc

  One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.

  Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

  Class II

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE Signa Voyager, Nuclear Magnetic Resonance Imaging System

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Food Recall · June 20, 2025

  Shovel and Spoon LLC

  Middle East Coast brand Tahini Dip; NET WT: 6 OZ (170g); INGREDIENTS: TAHINI, ORGANIC LEMON JUICE, GARLIC, OLIVE OIL, SEA SALT, ORGANIC TOASTED SESAME. CONTAINS SESAME; Locally Crafted by SHOVEL AND S

  Product may be contaminated with spoilage organisms.

  Class II

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Drug Recall · June 20, 2025

  ACCORD HEALTHCARE, INC.

  Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road,

  Subpotent Drug: Assay below the approved specification

  Class II

• Drug Recall · June 20, 2025

  ACCORD HEALTHCARE, INC.

  Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Ro

  Subpotent Drug: Assay below the approved specification

  Class II

• Drug Recall · June 20, 2025

  ACCORD HEALTHCARE, INC.

  Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Roa

  Subpotent Drug: Assay below the approved specification

  Class II

• Drug Recall · June 20, 2025

  ACCORD HEALTHCARE, INC.

  Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Roa

  Subpotent Drug: Assay below the approved specification

  Class II

• Drug Recall · June 20, 2025

  ACCORD HEALTHCARE, INC.

  Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road

  Subpotent Drug: Assay below the approved specification

  Class II

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Medical Device Recall · June 20, 2025

  Baxter Healthcare Corporation

  Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

  Certain Spectrum infusion pumps may have an incorrect version of software.

  Class I

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Medical Device Recall · June 20, 2025

  GE Medical Systems, LLC

  GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

  Class II

• Medical Device Recall · June 20, 2025

  Baxter Healthcare Corporation

  Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

  Certain Spectrum infusion pumps may have an incorrect version of software.

  Class I

• Drug Recall · June 19, 2025

  The Harvard Drug Group LLC

  Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61

  Defective container; blister packaging inadequately sealed.

  Class II

• Food Recall · June 19, 2025

  Face Rock Creamery LLC

  VAMPIRE SLAYER Garlic Cheddar Cheese Curds, net wt. 6 oz. Product is package in a sealed plastic cup with lid. UPC on 6oz. retail cup: 8 51222 00528 7. FaceRockCreamery.com MASTER CASE's label is rea

  Potential to be contaminated with Listeria monocytogenes

  Class I

• Drug Recall · June 19, 2025

  The Harvard Drug Group LLC

  Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017

  Defective container; blister packaging inadequately sealed.

  Class II

• Food Recall · June 19, 2025

  SHANDONG JOYWIN INTERNATIONAL TRADING CO.,LTD.

  SHOPPERS VALUE FRUIT COCKTAIL in HEAVY SYRUP, Net Wt. 22.5lbs, 24/15 OZ Cans per case.

  Undeclared Red No. 3 (E127)]

  Class III

• Medical Device Recall · June 19, 2025

  DIGIMED CO., LTD

  Portable X-ray system

  Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.

  Class II

• Medical Device Recall · June 18, 2025

  Olympus Corporation of the Americas

  Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

  Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

  Class II

• Food Recall · June 18, 2025

  Professional Botanicals, Inc.

  Product Name: Tense-X. Package: 175cc HDPE Bottle. Type: Vegetable Capsule. Count: 60. Dose: 2 Capsules. Product Sku: PB207

  Products contains Magnesium Salicylate.

  Class II

• Medical Device Recall · June 18, 2025

  Olympus Corporation of the Americas

  Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

  Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

  Class II

• Medical Device Recall · June 18, 2025

  Olympus Corporation of the Americas

  Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some

  Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

  Class II

• Food Recall · June 18, 2025

  Professional Botanicals, Inc.

  Product Name: Nutra Calm Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 90, Dose: 2 Capsules. Product Sku: PB248

  Products contains Magnesium Salicylate.

  Class II

• Medical Device Recall · June 18, 2025

  Stryker Corporation

  Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip

  Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

  Class II

• Medical Device Recall · June 18, 2025

  C.R. Bard Inc

  Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A31951

  Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.

  Class II

• Food Recall · June 18, 2025

  Professional Botanicals, Inc.

  Product Name: Total Comfort. Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 60, Dose: 2 Capsules. Product Sku: PB173.

  Products contains Magnesium Salicylate.

  Class II

• Medical Device Recall · June 18, 2025

  Medtronic, Inc.

  Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia app

  In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

  Class II

• Food Recall · June 18, 2025

  Lipari Foods Operating Company, LLC.

  JLM Manufacturing Dark Chocolate Nonpareils, 14oz clear plastic tub, UPC 7 60208 12450 1, item # 392303, 12 retail units per wholesale case

  Undeclared milk

  Class I

• Medical Device Recall · June 18, 2025

  Medtronic, Inc.

  Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia appli

  In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

  Class II

• Medical Device Recall · June 18, 2025

  Olympus Corporation of the Americas

  Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

  Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

  Class II

• Consumer Product Recall · June 18, 2025

  Polaris Industries Inc., of Medina, Minnesota

  Model Year 2023-2024 Ranger XP Kinetic and Model Year 2025 Pro XD Kinetic ROVs

  Water can leak through a cracked filter into the ROV's high-voltage charging harness components and cause a short circuit, posing a fire hazard.

  Unclassified

• Medical Device Recall · June 18, 2025

  Olympus Corporation of the Americas

  Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen w

  Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

  Class II

• Food Recall · June 18, 2025

  Krasnyi Oktyabr USA Inc

  ARAL FISH; ARAL SILVER VOBLA; WHOLE DRIED, SALTED ROACH FISH EVISCERATED; FISH ROE DRIED; Ingredients: whole eviscerated dried roach fish, caviar may be present, salt.; Distributed by Krasnyi Oktyabr;

  Clostridium botulinum (uneviscerated fish)

  Class I

• Consumer Product Recall · June 18, 2025

  Shaoxing ShangYu North Electron Manufacture Co. Ltd., of China

  4 Liter/6 Can Minifridges

  The recalled minifridges' electrical switch can short circuit, posing fire and burn hazards.

  Unclassified

• Medical Device Recall · June 18, 2025

  Stryker Corporation

  Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip

  Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

  Class II

• Medical Device Recall · June 18, 2025

  Olympus Corporation of the Americas

  Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

  Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

  Class II

• Food Recall · June 18, 2025

  Prestige Brands Holdings

  Little Remedies¿ Honey Cough 4 FL OZ (118 mL)

  contaminated with Bacillus cereus and may be spoiled

  Class II

• Medical Device Recall · June 18, 2025

  Olympus Corporation of the Americas

  Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

  Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

  Class II

• Medical Device Recall · June 18, 2025

  Osteotec Limited

  Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Sil

  There is the potential that the silicone implant may contain foreign material

  Class II

• Medical Device Recall · June 18, 2025

  Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

  Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

  Natus received two complaints of left side labeling show impedance for right side.

  Class II

• Medical Device Recall · June 18, 2025

  Olympus Corporation of the Americas

  Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

  Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

  Class II

• Consumer Product Recall · June 18, 2025

  Foshanshi Liyue Jiaju Youxian Gongsi, dba Crayan Inc., of China

  Crayan Mattresses

  The recalled mattresses fail to meet open flame flammability requirements in violation of federal safety standard for mattresses, posing a deadly fire hazard.

  Unclassified