Hawaii recalls

Sold nationwide. Veseacky children's pajama sets sold on Amazon do not meet mandatory federal safety standards for sleepwear and pose a risk of serious burns to children. The sets consist of a long-sleeve button-up top and matching pants, sold in various colors and prints from October 2020 through January 2026.

Serious·CPSC·Jun 18, 2026·Veseacky

Sold nationwide. Arrogantf white spa and hot tub drain covers do not meet federal safety standards for entrapment protection. They pose a risk of serious injury or death from entrapment and drowning, particularly to children. About 340 units were sold online through Amazon between September 2025 and March 2026.

Serious·CPSC·Jun 18, 2026·Arrogantf

Sold nationwide. GOPO Toys pull string teething toys have silicone strings that are longer and thinner than safety standards allow. The strings can reach the back of a child's throat and become lodged, causing choking or respiratory distress. The company has received three reports of strings reaching children's throats.

Serious·CPSC·Jun 18, 2026·GOPO Toys

Sold nationwide. BABESIDE toy sets sold on Amazon contain small parts that pose a choking risk to children under 3: a pacifier and a plush bear with detachable eyes. These pieces are not safe for young children and violate federal small parts rules.

Serious·CPSC·Jun 18, 2026·Huitong Crafts

Sold nationwide. Boston Scientific is removing Orca Sterile Single Use Air/Water and Suction Valves from distribution because the suction button is sticking more often than expected. These valves are used during gastrointestinal endoscopic procedures to control air and water flow on endoscopes. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·Boston Scientific

Sold nationwide. AVID Medical is recalling four Halyard kit types because sealed pouches were distributed without validated sterilization. The kits may not be sterile, and the recall includes 476 kits total, distributed in Iowa. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·AVID Medical4 products

Sold nationwide. Elekta's MOSAIQ Oncology Information System software (version 3.2) may fail to load an adapted baseline shift plan during cancer treatment delivery if a communication error occurs. This could affect the accuracy of radiation therapy positioning. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·Elekta

Sold nationwide. Abbott's Merlin PCS 3650 programmer software (versions 25.0.1 through 28.7.1) may malfunction during pacing capture threshold tests on pacemakers. When this occurs, the programmer may fail to successfully send the command to stop the test.

Moderate·FDA·Jun 17, 2026·Abbott

Sold nationwide. Boston Scientific is recalling the Model SC-4318 Clik X Anchor (Lot #35107836) because sterile anchors may lack proper sterility assurance. Approximately 43 units were distributed across six U.S. states.

Moderate·FDA·Jun 17, 2026·Boston Scientific

Sold nationwide. Boston Scientific is recalling two lines of reusable electrodes, CSK and TCN, because they may not meet expected performance levels. The recall covers 2 products with about 81,000 units total, distributed across the US and several other countries. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·Boston Scientific2 products

Sold nationwide. Some units of Inter-Med's Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit (catalog 504600-28) contain the package insert for Ferric Sulfate Gel instead. The wrong insert gives incorrect first aid instructions—specifically, it tells users to induce vomiting if the gel is swallowed, when the correct instructions say not to induce vomiting.

Moderate·FDA·Jun 17, 2026·Inter-Med

Sold nationwide. DT MedTech discovered that some Hintermann Series Talar Implant units labeled as left implants actually contained right implants inside the packaging. This mix-up was found through customer complaints. A total of 67 units across five US states and two countries are affected.

Moderate·FDA·Jun 17, 2026·DT MedTech

Sold nationwide. Three lots of Siemens Dimension Tacrolimus Flex Reagent Cartridges show a potential positive bias in quality control and patient test results. This means the cartridges may report tacrolimus levels that are higher than actual values. The affected lots are FA6254, FA6260, and FA6286.

Moderate·FDA·Jun 17, 2026·Siemens

Sold nationwide. The EXENT Analyser, an automated blood-test device, has a software issue where certain test plates were marked as passed without performing required quality checks. This could allow inaccurate M-protein measurements—either missed detections or wrong concentration values—to be reported to clinicians.

Moderate·FDA·Jun 17, 2026·The Binding Site

Sold nationwide. Medartis has recalled certain APTUS 5.0 headed cannulated compression screws (CCS) used in bone fixation surgery because the central hole in the screw is not properly centered. This affects 13 units across five states. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·Medartis

Sold nationwide. Sagemax Bioceramics is recalling NexxZr T Multi A3.5 W98-16mm zirconium oxide discs used in dental crowns and bridges. Some discs may have a reduced or missing dentin layer, which can weaken them and cause fractures when patients chew or bite.

Moderate·FDA·Jun 17, 2026·Sagemax

In2bones USA has recalled NeoSpan SuperElastic Compression Staples used in hand and foot surgery because the required Magnetic Resonance Imaging (MRI) safety symbol is missing from the product packaging, inner trays, and patient labels. This labeling omission could prevent patients and healthcare providers from knowing whether the implant is safe to use during an MRI scan.

Moderate·FDA·Jun 17, 2026·In2bones

Sold nationwide. When using two or four amplifiers together in certain configurations, the SD LTM 64 PLUS may display a 1-second timing delay between channel blocks. This delay could cause doctors to misinterpret EEG test results. The issue affects devices running specific firmware versions.

Moderate·FDA·Jun 17, 2026·Micromed

Sold nationwide. Avanos Medical is recalling 20 PEG feeding tube kits sold under the CORFLO and MIC Safety names. The kits were made with lidocaine hydrochloride injection that is itself subject to a supplier recall for quality issues. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·Avanos Medical20 products

Sold nationwide. HF Acquisition Co LLC is recalling the SporeTraq Mail-In Spore Testing Service (52 tests) because some test strips were not incubated for the correct length of time. The test strips are used by healthcare facilities to verify that their sterilization equipment is working properly. Incorrect incubation times can produce unreliable test results.

Moderate·FDA·Jun 17, 2026·HF Acquisition2 products

Sold nationwide. InspireMD is recalling six sizes of its CGuard Prime Carotid Stent System, covering 1,377 units in total. The stent delivery system may run into complications during deployment, which can cause high resistance or prevent the stent from being deployed. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·InspireMD6 products

Sold nationwide. D.O.R.C. has recalled certain TDC VELOCE 23G Two Dimensional Cutters used in ophthalmic surgery because the outer knife can become loose during use. An increased number of complaints about this issue prompted the recall. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·D.O.R.C3 products

Sold nationwide. Fresenius Medical Care is notifying users of potential leaks in Bicarby Dialysate products during setup and use. Fluid leaks from the luer-lock connection can create a slip and fall hazard on the floor where treatment is taking place.

Moderate·FDA·Jun 17, 2026·Fresenius Medical Care

Sold nationwide. Some Berlin Heart EXCOR Pediatric Ventricular Assist Device blood pumps have mismatched expiration dates between the inner and outer package labels. The inner package shows an incorrect expiration date, which could cause confusion and delay surgical procedures if the device is not used on time.

Moderate·FDA·Jun 17, 2026·Berlin Heart

Sold nationwide. Certain lots of Mozarc Medical's Mahurkar Elite PASS Trays are missing the Tegaderm CHG antimicrobial dressing that is supposed to be included in the kit. These trays are used in hospitals and clinical settings for acute hemodialysis, aphaeresis, and infusion procedures. The missing dressing may affect the product's intended sterile barrier protection.

Moderate·FDA·Jun 17, 2026·Mozarc Medical

Sold nationwide. GE HealthCare found a possible problem with an electrical cable in certain Allia IGS X-ray systems that use Gaia generators. The issue could expose service personnel to electrical shock while working inside the C-FRT cabinet with power on. This recall includes 5 product lines, with 173 affected units in total.

Moderate·FDA·Jun 17, 2026·GE5 products

Sold nationwide. ICU Medical is recalling three Plum infusion pump models, covering 13,613 units each. Under certain conditions, the pump may not show a soft limit alert or warn the clinician of a soft limit violation before delivery starts, which could lead to under- or over-delivery of medication. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·ICU Medical3 products

Sold nationwide. A manufacturing defect in the Fresh Roast Systems ColorTrack model BENCH R-100 could, under rare misuse conditions, expose users to infrared laser light levels higher than the product's safety rating. No injuries have been reported. The defect affects a small number of units.

Moderate·FDA·Jun 17, 2026·Fresh Roast Systems

Sold nationwide. Wild Coast Brew is recalling three loose-leaf tea products: The Shadow Winter Spice Black Tea, The Creator Ginger Lemongrass Tisane, and The Lover Tart Chocolaty Tisane. The teas contain ashwagandha root, which the FDA considers an unsafe food additive. The products were sold nationwide, and no injuries have been reported.

Moderate·FDA·Jun 17, 2026·The Shadow3 products

Sold nationwide. Total Nutrition Inc is recalling TNVitamins and Doctor's Pride brand moringa capsule supplements because they may be contaminated with Salmonella. The recall affects 13,000 bottles sold nationwide across multiple lot numbers.

Serious·FDA·Jun 17, 2026·TNVitamins