Safety Recalls
RSS ↗15,271 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 7,701–7,750 of 15,271
- Class II
Medical Device Recall · February 28, 2025
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.Potential for the gold unlock button to separate from the inserter.
- Class II
Medical Device Recall · February 28, 2025
Monterey AL Implant Inserter; 22mm; Catalog 48019140.Potential for the gold unlock button to separate from the inserter.
- Class II
Drug Recall · February 28, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., BeCGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Class II
Drug Recall · February 28, 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Class II
Drug Recall · February 28, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., BerCGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Class II
- Class II
Drug Recall · February 28, 2025
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8Chemical Contamination: Presence of benzene
- Class II
Drug Recall · February 28, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., BeCGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Class II
Medical Device Recall · February 28, 2025
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.Potential for the gold unlock button to separate from the inserter.
- Class II
Medical Device Recall · February 28, 2025
Phoroptor VRx Digital Refraction System Model Numbers: 16241The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
- Class II
Medical Device Recall · February 28, 2025
Phoroptor VRx Digital Refraction System Model Numbers: 16242The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
- Class II
Medical Device Recall · February 27, 2025
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voya limited number of lots were manufactured with an incorrect cylinder power.
- Class I
Medical Device Recall · February 27, 2025
t:slim X2 Insulin Pump with Interoperable TechnologyA software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
- Unclassified
Consumer Product Recall · February 27, 2025
Goplus Corporation, dba Costway, of Fontana, California
Babyjoy High ChairsThe recalled high chairs pose a fatal suffocation risk because they were marketed, intended, or designed for infant sleep, and they have an incline angle greater than 10 degrees in violation of the federal Safe Sleep for Babies Act. In addition, the high chair poses a deadly entrapment hazard because the opening between the seat and tray is large enough that a child can become entrapped in it, which is a violation of the federal regulations for high chairs.
- Unclassified
Consumer Product Recall · February 27, 2025
Prestige Solo, Prestige Excellence, and Aerco Esteem condensing gas boilersThe boilers can release carbon monoxide (CO) due to delayed ignitions or component damage, posing a risk of serious injury or death.
- Class II
Drug Recall · February 27, 2025
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDStability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
- Class I
Medical Device Recall · February 27, 2025
Tandem Mobi Insulin Pump with Interoperable TechnologyA software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
- Unclassified
Consumer Product Recall · February 27, 2025
Nic Impex ARVA Corp., of Orem, Utah
ARVA Neo BT Pro Avalanche TransceiversA fuse within the avalanche transceiver can be defective and cause power to drain from the battery, posing a risk of loss of emergency communication which could result in serious injury or death.
- Class II
Drug Recall · February 27, 2025
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. ThousandStability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
- Class II
Medical Device Recall · February 27, 2025
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.The hardness not meeting the material specification and may cause the diamond bur to bend.
- Class II
Food Recall · February 27, 2025
Coyote Valley Sour Cream & Onion Chips, Net Wt. 5oz, UPC 744234810775, Item # 8014265, Food Express USA, Dallas, TX 75261Product contains higher sodium amount than stated on label
- Class II
Medical Device Recall · February 27, 2025
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
- Unclassified
Consumer Product Recall · February 27, 2025
Kichler Lighting LLC, of Solon, Ohio
Ellerbeck Wall SconcesThe wall sconce's electrical wires can become damaged at the adjustable joints, posing a risk of electric shock.
- Class II
Medical Device Recall · February 27, 2025
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
- Unclassified
Consumer Product Recall · February 27, 2025
F21 OpCo LLC, dba Forever 21, of Los Angeles, California
Forever 21 Children's PajamasThe recalled pajamas violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.
- Unclassified
Consumer Product Recall · February 27, 2025
P.J. Salvage, of Los Angeles, California
P.J. Salvage Pajama Sets and RobesThe recalled children’s pajama sets and robes violate the flammability regulations for children’s sleepwear, posing a risk of burn injuries and death to children.
- Class II
Medical Device Recall · February 27, 2025
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.
- Unclassified
Consumer Product Recall · February 27, 2025
Canyon Bicycles USA Inc., of Carlsbad, California
Canyon Speedmax CF Triathlon BicyclesThe aerostem fork steerer tube on the recalled bicycles can crack or break, posing fall and injury hazard.
- Unclassified
Consumer Product Recall · February 27, 2025
Goal Zero LLC, of Draper, Utah
Goal Zero Solar Series Combiner Cables for Solar PanelsThe recalled combiner cables can malfunction when used with Nomad-series solar panels, posing a fire hazard.
- Unclassified
Consumer Product Recall · February 27, 2025
Head Rush Technologies, of Louisville, Colorado
TRUBLUE iQ and TRUBLUE iQ+ Auto BelaysThe recalled auto belay device can fail to retract, posing a fall hazard and risk of serious injury or death.
- Unclassified
Consumer Product Recall · February 27, 2025
Bespoke Clothing Valley Inc., (Royalbelle), d/b/a Zoomie Kids, of China
Style Life Eleven Baby LoungersThe recalled baby loungers violate the federal safety regulations for Infant Sleep Products because the sleeping pad is too thick, posing a suffocation hazard; an infant could fall out of an enclosed opening at the sides of the lounger or become entrapped; and the sides are too low to contain the infant and the loungers do not have a stand, posing a fall hazard. These violations create an unsafe sleeping environment for infants.
- Class II
Medical Device Recall · February 26, 2025
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/ADue to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
- Class III
Food Recall · February 26, 2025
Flor de Michoacan Blue Hawaiian Artificially Flavored Beverage Concentrate. 1 Gallon (3.78L) Pasteurized. Keep Frozen. UPC 1 80596-00039 1. Processed for: Paletas Ice Cream, El Paso, Texas 7990Undeclared Red #3
- Class II
Medical Device Recall · February 26, 2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemiBeckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.
- Class I
Medical Device Recall · February 26, 2025
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80RTracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
- Class I
Medical Device Recall · February 26, 2025
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 AspirationAspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
- Class II
Medical Device Recall · February 25, 2025
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208SThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Baxter Floor mounting column TS 7500 U, Product Code 1730732There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter Mobile column TruSystem 7500, Product Code 1717023There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500, Product Code 4091000There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Drug Recall · February 25, 2025
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.Presence of Foreign Tablets/Capsules.
- Class II
Medical Device Recall · February 25, 2025
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Drug Recall · February 25, 2025
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93Failed Dissolution Specifications - low dissolution results
- Class II
Medical Device Recall · February 25, 2025
Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24SThe air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
- Class II
Medical Device Recall · February 25, 2025
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Baxter Stationary column TruSystem 7500, Product Code 1717020There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter Stationary column TruSystem 7500 U, Product Code 1730731There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004SThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.