Medical device recalls
2,526 federal recalls in the last 12 months. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-09-09FDA-DevicePhilips North America LlcClass IIPhilips Brilliance CT 64 recalled for radiation issue
Philips has identified an unintended radiation issue affecting Philips Brilliance CT 64 CT scanner systems (Software 4.1.10.x) that could impact equipment performance. The issue affects multiple Philips CT system models including IQon, iCT, Ingenuity, and Brilliance CT 64.
- 2026-09-09FDA-DevicePhilips North America LlcClass IIPhilips Ingenuity CT recalled for radiation issue
Philips has identified an unintended radiation issue affecting Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could impact equipment performance. The issue affects specific software versions and product codes distributed in the US and US territories.
- 2026-09-09FDA-DevicePhilips North America LlcClass IIPhilips IQon Spectral CT recalled for radiation issue
Philips has identified an unintended radiation issue affecting the IQon Spectral CT and related CT systems (iCT, Ingenuity, and Brilliance CT 64 models). This issue could affect the performance of the equipment. The problem was found in software version 4.7.7.x.
- 2026-09-09FDA-DevicePhilips North America LlcClass IIPhilips Brilliance iCT recalled for radiation issue
Philips has identified an unintended radiation issue affecting Philips Brilliance iCT, Brilliance iCT Upgrades, and Brilliance iCT SP CT scanner systems running software version 4.1.10.x. This issue could affect the performance and safety of the equipment.
- 2026-08-12FDA-PRKettle CuisineMarketside Tomato Bisque Soup Kit recalled for Listeria risk
Kettle Cuisine recalled Marketside Tomato Bisque Soup Kit (14 oz) sold at Walmart because routine testing found a presumptive positive result for Listeria monocytogenes, a bacterium that can cause serious infections. The affected products were distributed from June 30 to July 7, 2026, to select Walmart stores across 30 states. No illnesses have been reported to date.
- 2026-08-04FDA-PRFresenius KabiFresenius Kabi Morphine syringes recalled for wrong opioid in packaging
Fresenius Kabi recalled one lot of Morphine Sulfate Injection 2 mg/1 mL prefilled syringes due to a labeling error. Packages labeled as morphine may actually contain Dilaudid (hydromorphone), a different and more potent opioid. Using the wrong medication could cause serious respiratory problems or death, especially in patients not used to opioids or those with lung disease.
- 2026-07-30FDA-PRUkrop's Homestyle FoodsUkrop's baked goods recalled for aluminum sliver risk
Ukrop's Homestyle Foods discovered a small aluminum sliver in a baking pan used to prepare six products, including Baked Spaghetti, Chicken Cobbler, and Bread Pudding. Out of caution, the company is recalling all products made with similar pans between July 1 and July 30, 2026. No injuries have been reported.
- 2026-07-30FDA-PRBDBD intraosseous needle sets recalled for obturator removal difficulty
BD is recalling specific lots of its Intraosseous Vascular Access System Needle Sets because some users have had difficulty removing the obturator (stylet) after needle placement. The affected needle sets were manufactured with out-of-tolerance dimensions and distributed between September 2024 and June 2026. If the obturator cannot be removed, clinicians may need to obtain alternative vascular access, potentially delaying urgent care.
- 2026-07-29FDA-DeviceKarl Storz EndoscopyClass IIKarl Storz hysteroscope kits recalled for expired sterile seals
Karl Storz Flexible Hystero-Fiberscope Kits with certain serial numbers contain expired single-use endoscopic seals that may not maintain sterility during gynecological procedures. The affected seals expired in January 2023 and were distributed across 15 U.S. states.
- 2026-07-29FDA-DeviceAlphatec Spine, Inc.Class IIAlphatec SafeOp Patient Interface recalled for monitoring loss risk
The SafeOp Patient Interface (REF: AIX11240), part of the SafeOp 3 Neural Informatix System used during spine surgery, can lose or drop its nerve monitoring signal due to a software problem. When this happens, the device may show system errors, lose connection to the surgeon's tablet, and require a restart—potentially extending surgery time or changing the surgical plan.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline surgical kits recalled for Bacillus contamination risk
Medline Industries is recalling nine types of surgical convenience kits that contain BD PurPrep solution. The solution may be contaminated with low levels of Bacillus species, a bacterium that could pose a risk if the kits are used in sterile procedures. The recall affects specific lot numbers of joint, spine, and neurological surgery kits distributed to hospitals and surgical centers in ten U.S. states.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline NEURO PACK kits recalled for Bacillus contamination
Medline Industries recalled specific NEURO PACK medical convenience kits because the included BD PurPrep 26 mL solution may contain low levels of Bacillus species bacteria. The contamination was identified in kits distributed to hospitals and medical facilities in 10 U.S. states.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline shoulder and ortho kits recalled for Bacillus contamination
Medline Industries is recalling three types of medical convenience kits (Shoulder Pack and Major Ortho Kit models) because the BD PurPrep solution included in them may contain low levels of Bacillus species bacteria. The contamination was discovered in specific lot numbers distributed across ten U.S. states.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline surgical kits recalled for Bacillus contamination risk
Medline Industries is recalling specific pediatric open heart and cardiac surgical convenience kits that contain BD PurPrep solution potentially contaminated with low levels of Bacillus species. The affected kits were distributed to healthcare facilities in 10 states. No injuries have been reported.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline Foley catheter kits recalled for surface contamination risk
Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled because the catheters have an increased amount of raw material on their surface. This contamination may cause staining and could be harmful if the catheters are used.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline Foley catheter kits recalled for surface contamination
Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled because the catheters have an increased amount of raw material on their surface. This material may cause staining and could potentially be harmful if the catheters are used.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline Foley catheter kits recalled for surface contamination
Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled. The catheters contain increased amounts of raw material on the surface, which may cause staining and could be harmful if the catheters are used.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline Foley catheter kits recalled for surface contamination
Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) include catheters with excess raw material on the surface. This material may cause staining and could be harmful if the catheters are used.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline Bard Foley Catheter kits recalled for surface contamination
Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled due to increased raw material on the catheter surface. This contamination may cause staining and could potentially be harmful if the catheters are used.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline Foley catheter kits recalled for surface contamination
Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French) have been recalled because the catheters have an increased amount of raw material on their surface. This contamination may cause staining and could be harmful to patients.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline urology kits recalled for defective Foley Catheters
Medline convenience kits used in urology robotic procedures contain Bard Silastic Foley Catheters with excess raw material on the catheter surface. This material may cause staining and could potentially harm patients. The catheters were originally recalled by the manufacturer due to this manufacturing defect.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline DaVinci Prostate Pack recalled for defective catheters
Medline convenience kits containing Bard Silastic Foley Catheters have been recalled because the catheters have an increased amount of raw material on their surface. This material may cause staining and could be harmful if the catheters are used.
- 2026-07-29FDA-DeviceMedline Industries, LPClass IIMedline Foley catheter kits recalled for surface contamination risk
Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled because the catheters have an increased amount of raw material on their surface. This contamination may cause staining and could be harmful if the catheters are used.
- 2026-07-29FDA-DeviceMedtronic MiniMed, Inc.Class IIMedtronic MiniMed Go App recalled for missed nighttime alerts
Medtronic MiniMed Go app versions 1.0.0 and 1.1.0 have a software bug: when the "Set day and night" feature is turned off, missed-dose and high-glucose alerts may fail to trigger at night. This means users may not realize they've missed insulin doses, potentially delaying treatment and raising blood sugar levels dangerously.
- 2026-07-29FDA-DeviceEmano Metrics, Inc.Class IIEmano Flow app recalled for inaccurate urinary flow measurements
Emano Flow, a smartphone app that measures urinary flow rate and volume, produced inaccurate results during a two-month period (March 22–May 29, 2026). The app recorded audio at an incorrect frequency setting, causing measurements to be systematically over-reported. The company has provided corrected results to healthcare teams.
- 2026-07-29FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus UHI-4 insufflation unit recalled for display and air delivery failure
The Olympus UHI-4 insufflation unit may experience unexpected shutdowns where the front panel display turns off and air delivery stops during use. This affects about 3,087 units distributed worldwide. No injuries have been reported.
- 2026-07-29FDA-DeviceKENT IMAGING, INC.Class IIKent Imaging SnapshotGLO wound imager recalled for battery charge issue
The SnapshotGLO device's software cannot recognize when its battery has fully discharged into a low-power shipping mode. When this happens, the device will not resume charging when plugged in and becomes temporarily unusable until the issue is corrected.
- 2026-07-29FDA-DeviceMicro Therapeutics, Inc.Class IIMicro Therapeutics embolization devices recalled for incorrect labeling
Micro Therapeutics Pipeline Flex Embolization Devices have incorrect labeling on some units. Devices labeled as 3.0 mm x 20 mm actually contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm actually contain 20 mm implants. This mismatch could lead to incorrect implant selection during surgery.
- 2026-07-29FDA-DeviceAVID Medical, Inc.Class IIHalyard line insertion pack recalled for seal defect risk
Certain Halyard STANDARD LINE INSERTION PACK kits (Model PVHM234-01) have a defect in the silicone seal that may not seal properly. This defect can cause the seal to dome inward, potentially blocking fluid flow or allowing fluid to leak where it shouldn't.
- 2026-07-29FDA-DeviceBoston Scientific CorporationClass IIBoston Scientific TheraSphere 360 Y-90 dose calculation software issue
The TheraSphere 360 Y-90 Management Platform has a software bug that can cause incorrect dose calculations. When a user modifies calculation inputs and recalculates, the new dose is computed correctly on screen, but vials previously added to the cart do not automatically update to match the revised calculation.
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