Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 10,101–10,150 of 15,364
- Class II
Medical Device Recall · September 20, 2024
Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervoIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous systIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Unclassified
Consumer Product Recall · September 19, 2024
Wee Gallery Inc., of St. Petersburg, Florida
Baby Tummy Time GalleryThe recalled Baby Tummy Time Gallery art card pockets have clear plastic coverings that contain levels of a phthalate that exceeds the federal phthalates ban. Phthalates are toxic if ingested by young children and can cause adverse health effects.
- Unclassified
Consumer Product Recall · September 19, 2024
Polaris Industries Inc., of Medina, Minnesota
Model Year 2024 RANGER XD 1500 and Crew XD 1500 Recreational Off-Road Vehicles (ROVs)The winch wiring can overheat while in use, posing a fire hazard and risk of serious injury to the rider or passenger.
- Unclassified
Consumer Product Recall · September 19, 2024
Polaris Industries Inc., of Medina, Minnesota
Model Year 2023-2024 Polaris Sportsman 850, XP 1000, and XP 1000 S ATVs and fuel pump kits and fuel tank assembliesThe ATV can leak fuel at the fuel pump flange outlet, posing a fire hazard and risk of serious injury to the rider or passenger.
- Unclassified
Consumer Product Recall · September 19, 2024
Jo-Ann Stores LLC, of Hudson, Ohio
Place & Time battery-operated desk lampsThe desk lamp's battery compartment can overheat while using the USB charging cord, posing a fire hazard.
- Unclassified
Consumer Product Recall · September 19, 2024
Yangkeqiang, dba Inforce, of China
Ceither Adult Portable Bed RailsThe recalled bed rails violate federal regulations for adult portable bed rails, posing a serious entrapment hazard and risk of death by asphyxiation. When the bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress.
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Class II
Medical Device Recall · September 19, 2024
Ad-Tech Medical Instrument Corporation
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth ElectrodeAd-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
- Class II
Medical Device Recall · September 19, 2024
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system includingMislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Class I
Drug Recall · September 19, 2024
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2Presence of Particulate Matter: Presence of glass particle.
- Class II
Medical Device Recall · September 19, 2024
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75USSpecific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
- Class I
Food Recall · September 19, 2024
Lactaid Lactose Reduced milk 1. 96 oz Lactaid Whole Milk 2. 96 oz Lactaid 2% Milk 3. 96oz Lactaid 1% Milk 4. 96oz Lactaid Fat Free Milk (1607) 5. 96oz Lactaid 2% Calcium Enriched Milk (15567)Milk may contain undeclared almond from almond milk
- Class II
Medical Device Recall · September 19, 2024
Ad-Tech Medical Instrument Corporation
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth ElectrodeAd-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating Table TruSystem 7000 V, Product code REF 1841050The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating Table TruSystem 7000, Product code REF 1841046The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Class II
Medical Device Recall · September 19, 2024
Ad-Tech Medical Instrument Corporation
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth ElectrodeAd-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Unclassified
Consumer Product Recall · September 19, 2024
Platform Beds with Upholstered Square Tufted HeadboardsThe recalled beds can sag, break, or collapse during use, posing fall and injury hazards to consumers.
- Unclassified
Consumer Product Recall · September 19, 2024
Cabinet HeatersThe crimp holding a wire in place in the cabinet heater is not properly finished and can result in the wire detaching, posing an electrocution hazard.
- Unclassified
Consumer Product Recall · September 19, 2024
Memovan Technology Industrial Co. Limited, (dba Newmemo), of China
Newmemo Children's Ring SetsThe rings contain levels of lead that exceed the federal lead content ban and levels of cadmium that are prohibited in children's products by the Federal Hazardous Substances Act. Lead and cadmium are toxic if ingested by young children and can cause adverse health effects.
- Class II
Medical Device Recall · September 18, 2024
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system.
- Class II
Medical Device Recall · September 18, 2024
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, eachDue to oximeters not having FDA market approval or clearance to distribute in the U.S.
- Class II
Medical Device Recall · September 18, 2024
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator IThe Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
- Class II
Medical Device Recall · September 18, 2024
American Surgical Company, LLC
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/AProduct defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.
- Class II
Medical Device Recall · September 18, 2024
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/BoxDue to oximeters not having FDA market approval or clearance to distribute in the U.S.
- Class II
Medical Device Recall · September 18, 2024
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collectThe reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.
- Class I
Drug Recall · September 18, 2024
Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
- Class II
Drug Recall · September 18, 2024
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1CGMP deviations
- Class II
Medical Device Recall · September 18, 2024
Olympus Corporation of the Americas
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is inTo better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.
- Class II
Medical Device Recall · September 17, 2024
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical informatioThe overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided
- Class II
Medical Device Recall · September 17, 2024
Mckesson Medical-Surgical Inc. Corporate Office
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed testThe Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. This may lead to delay in patients' results.
- Class II
Medical Device Recall · September 17, 2024
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopiA Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length of the device, resulting in an interference fit at the cone, may caus an extension in surgery
- Class II
Medical Device Recall · September 17, 2024
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01There is discrepant labeling on the inner and outer packaging of the device.
- Class II
Medical Device Recall · September 17, 2024
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product DesDue to pin coming off of handles.