Recalls — last 30 days
- 2026-02-05CPSCKitosun Original Company Limited, dba Kitosun, of ChinaKitosun Submersible 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 as required by Reese's Law. When children swallow button cell or coin batteries, the ingested batteries can cause serious injuries, internal chemical burns, and death, posing an ingestion hazard to children.
- 2026-02-05CPSCGuangzhou Feifan Kuajing Supply Chain Co., Ltd. dba Gumili Beauty, of ChinaGM Gumili Wintergreen Essential Oil Bottles Recalled Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging; Sold on Amazon by Gumili Beauty
The essential oil contains methyl salicylate, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging for the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
- 2026-02-05CPSCSalvia Cosmeceuticals, of IndiaOrganic Zing Birch Essential Oil Bottles Recalled Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging; Sold on Amazon by Linkers
The essential oil bottles contain methyl salicylate, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The bottles for the products are not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
- 2026-02-05CPSCLittle Cow Company LLC, of Portland, OregonLittle Cow Company Recalls 9 oz Candles in Glass Jars Due to Fire, Burn and Laceration Hazards
The glass jar holding the candle can crack or break during use, posing fire, burn and laceration hazards.
- 2026-02-05CPSCLola Plus The Boys Inc., of Chicago, IllinoisLola Plus The Boys Recalls Youth Clothing with Drawstrings Due to Risk of Serious Injury or Death from Strangulation Hazard; Violates Federal Rule for Children's Upper Outerwear
The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children due to the strangulation hazard. The clothes are in violation of the federal rule for children's upper outerwear and present a substantial product hazard.
- 2026-02-05CPSCJinjiangshi XunMai Network Technology Co., Ltd., dba Semfri, of ChinaSemfri Children's Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets
The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, positional stability, labeling and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.
- 2026-02-05CPSCHuizhou Sunhouse Home Furnishings Co., Ltd., of ChinaShintenchi 6-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.
- 2026-02-05CPSCGuangzhou Tenghui Fragrance & Flavor Co., Ltd., of ChinaZan International Trading Recalls Lotus Joy Sweet Birch Essential Oil Bottles Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging
The essential oil bottles contain methyl salicylate, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The bottles are not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.
- 2026-02-04FDA-DeviceMiach OrthopaedicsClass IIBEAR Implant. Model Number: 1000.
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
- 2026-02-04FDA-DeviceLSL Healthcare Inc.Class IILSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
- 2026-02-04FDA-DeviceLimFlow, Inc.Class IIBrand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
Incorrect expiration date
- 2026-02-04FDA-DeviceCareFusion 303, Inc.Class IIBD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
- 2026-02-04FDA-DevicePhilips North AmericaClass IISmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IISmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIUpgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIMR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIIngenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIIngenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIIngenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIIngenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIIngenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIIngenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIIngenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIEvolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DevicePhilips North AmericaClass IIEvolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- 2026-02-04FDA-DeviceCardinal Health 200, LLCClass IIChest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
- 2026-02-04FDA-DeviceZimmer Surgical IncClass IIBrand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS Product Description: A.T.S 3200TS Tourniquet Systems Component: N/A
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
- 2026-02-04FDA-DeviceZimmer Surgical IncClass IIBrand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIMedline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X; 3) TOTAL HIP PACK, Kit SKU DYNJ04809N; 4) MAIN/LAMINECTOMY PACK-LF, Kit SKU DYNJ0565499AN; 5) SCC/SPOC HAND & FOOT PACK, Kit SKU DYNJ27164Q; 6) ORTHO SPINE, Kit SKU DYNJ40221G; 7) URO GYN PACK, Kit SKU DYNJ45311J; 8) LAMINECTOMY PACK, Kit SKU DYNJ46330C; 9) DJ ORTHO SPINE, Kit SKU DYNJ48980M; 10) CERVICAL PACK, Kit SKU DYNJ52995F;
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
- 2026-02-04FDA-DeviceMedline Industries, LPClass IIMedline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.