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U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

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926–950 of 26417

HighFDA (Drugs)·D-0410-2026·2026-04-08
Eye drops recall due to lack of sterility assurance
K.C. Pharmaceuticals is recalling Quality Choice Moisturizing Relief Eye Drops and related brand variants nationwide due to lack of sterility assurance. Approximately 303,216 bottles may be affected.
Product
QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS — QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1745-2026·2026-04-08
MiniMed 720G Insulin Pump Dosing Error Related to Pump Position
Medtronic MiniMed 720G insulin pumps can deliver incorrect insulin doses based on pump position relative to the infusion site, potentially causing severe low or high blood sugar.
Product
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0412-2026·2026-04-08
Lubricating Eye Drops Recalled Nationwide Due to Sterility Assurance Concerns
Multiple brands of lubricating eye drops manufactured by K.C. Pharmaceuticals have been recalled nationwide due to lack of assurance of sterility. Consumers should stop using affected bottles and consult their healthcare provider if concerned.
Product
LEADER ULTRA LUBRICATING EYE DROPS — LEADER ULTRA LUBRICATING EYE DROPS (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1659-2026·2026-04-08
Philips Allura Xper FD10C X-ray System Foot Switch Malfunction
Philips is recalling Allura Xper FD10C X-ray imaging systems due to a wired foot switch malfunction that may prevent or intermittently interrupt imaging. The recall affects 15 units distributed across the U.S. and internationally.
Product
Allura Xper FD10C; System Code: 722001;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0413-2026·2026-04-08
Tetrahydrozoline Eye Drops Recalled for Lack of Sterility Assurance
GoodSense Eye Drops Original Formula and related store brands are being recalled nationwide due to lack of assurance of sterility. The recall affects 378,144 bottles with specific lot numbers and expiration dates.
Product
GOODSENSE EYE DROPS ORIGINAL FORMULA — GOODSENSE EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0408-2026·2026-04-08
Tramadol hydrochloride 50 mg tablets recalled for carcinogenic impurity
Amneal Pharmaceuticals is recalling Tramadol Hydrochloride 50 mg tablets due to a carcinogenic impurity found outside acceptable specifications during testing. The recall affects medication distributed nationwide.
Product
TRAMADOL HYDROCHLORIDE — TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1749-2026·2026-04-08
Paradigm Real-Time Insulin Pumps Recalled for Gravity-Based Delivery Errors
Medtronic's Paradigm insulin pumps may deliver incorrect insulin doses when elevated or lowered relative to the infusion site due to gravitational pressure changes. This can cause severe high or low blood sugar complications.
Product
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1664-2026·2026-04-08
Philips X-ray System Imaging Failure with Wired Foot Switch
Philips ALLURA Xper FD20 biplane X-ray systems may fail to initiate imaging or operate intermittently when using the wired foot switch. A total of 461 units were affected.
Product
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2026·2026-04-08
Surgical Bone Tap with Incorrect Threading Due to Manufacturing Error
Synthes recalled 77 units of VOLT Locking Screw Tap due to a manufacturing error where the wrong product lot was shipped, resulting in incorrect thread dimensions.
Product
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1668-2026·2026-04-08
Philips Allura Xper X-ray System: Wired Foot Switch May Fail to Initiate Imaging
Philips is recalling Allura Xper medical imaging systems due to wired foot switch failures that may prevent X-ray imaging from initiating or cause intermittent operation. No injuries have been reported, but affected units should be checked immediately.
Product
Allura Xper FD20/10; System Code: 722029;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1748-2026·2026-04-08
Paradigm Insulin Pump: Elevation Can Cause Incorrect Delivery
Medtronic MiniMed Paradigm insulin pumps (MMT-712, MMT-715) can deliver too much or too little insulin when the pump is positioned higher or lower than the injection site, causing severe low or high blood sugar.
Product
Paradigm Insulin Pump (MMT-712, MMT-715)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1690-2026·2026-04-08
Medline ENFIT G-Tube Connector Recalled for Defective Seal Formation Risk
Medline is recalling 651,789 ENFIT G-Tube Connectors because they may not form a proper seal with compatible feeding devices, risking leakage that could delay care and cause fluid loss.
Product
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1733-2026·2026-04-08
eTRAX Needle System Starter Kit 16G Position Identification Error
Civco Medical Instruments is recalling the eTRAX Needle System Starter Kit 16G for Aurora Trackers due to an inspection and programming error that may cause the needle tip position to be incorrectly identified on the user interface.
Product
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1762-2026·2026-04-08
Burlington Medical Half Aprons Subject to Recall for Attenuation Material Degradation
Burlington Medical is recalling half aprons containing Xenolite 800 attenuation material manufactured between January 16, 2025, and January 21, 2026, due to potential material degradation that may reduce protective efficacy.
Product
Burlington Medical, Half Aprons.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0641-2026·2026-04-08
Roasted peanuts recalled for undeclared banned sweetener cyclamate
Mei Heong Yuen tangerine flavor roasted peanuts are recalled because they contain cyclamate, a sweetener banned in the U.S.
Product
MEI HEONG YUEN TANGERINE FLAVOR ROASTED PEANUTS; NET 9.17 oz (260g); Ingredients: Peanuts, Salt, Sugar, Liquorice, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Maltol; Shelf Life: 18 Months; Manufacturer: Heshan Mei Heong Yuen Food Pte Ltd; Distributor in USA: Super Wor
Category
Food
Distribution
19 states
ModerateFDA (Devices)·Z-1663-2026·2026-04-08
X-ray imaging system intermittent operation due to foot switch malfunction
Philips ALLURA Xper FD20 X-ray systems may fail to initiate imaging or operate intermittently when using the wired foot switch. Affected medical facilities should contact Philips for service evaluation.
Product
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1678-2026·2026-04-08
Philips Azurion 7 M20 X-ray system foot switch may fail to initiate imaging
Philips has identified a foot switch defect in Azurion 7 M20 X-ray systems that may prevent imaging initiation or cause intermittent imaging operation. Approximately 5,167 units are affected worldwide, including 1,728 in the U.S.
Product
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1754-2026·2026-04-08
Burlington Medical Vest recalled for potential attenuation material degradation
Burlington Medical Vest models with Xenolite 800 material manufactured January 2025–January 2026 are recalled due to potential degradation of protective attenuation material over time. No injuries reported.
Product
Burlington Medical, Vest
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0644-2026·2026-04-08
Mama Rose's Prickly Pear Salad Dressing recalled for undeclared sulfites
The Maros Group, LLC is recalling Mama Rose's Prickly Pear Salad Dressing (12 oz bottles) distributed in Arizona because the product contains undeclared sulfites, which can pose a health risk to people with sulfite sensitivity.
Product
Mama Rose's Prickly Pear Salad Dressing. 12 oz (340 g) glass bottle with gold cap.
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1666-2026·2026-04-08
ALLURA Xper FD20 Biplane OR Table wired foot switch X-ray imaging malfunction
Philips is recalling the ALLURA Xper FD20 Biplane OR Table due to a wired foot switch malfunction that may prevent X-ray imaging from being initiated or cause it to operate intermittently.
Product
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1689-2026·2026-04-08
Jiffy Composite Polisher Cups may crumble and disrupt dental treatment
The Jiffy Original Composite Polisher Cups (REF 7011) may crumble and break apart, potentially delaying patient treatment. Ultradent Products is recalling 2,508 units from 30 US states and Puerto Rico.
Product
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Category
Medical Device
Distribution
31 states
ModerateFDA (Food)·H-0643-2026·2026-04-08
Mei Heong Yuen Garlic Flavor Roasted Peanuts Recalled for Banned Sweetener
Mei Heong Yuen Garlic Flavor Roasted Peanuts (9.17 oz) are being recalled because they contain cyclamates, a banned sweetener. The product was distributed across multiple states.
Product
MEI HEONG YUEN GARLIC FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Garlic, Liquorice, Sugar, Saccharin; Shelf Life: 18 Months; Manufacturer: Heshan Mei Heong Yuen Food Pte Ltd; Distributor in USA: Super World Trading Inc 28 Varick Ave. Brooklyn, NY 11237; U
Category
Food
Distribution
19 states
ModerateFDA (Devices)·Z-1737-2026·2026-04-08
Medical Device Needle Sensor Recalled for Aurora Trackers Inspection Error
Civco Medical Instruments is recalling the eTRAX Needle Sensor for Aurora Trackers due to an inspection and programming error that could result in incorrect needle tip position identification on the user interface.
Product
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
Category
Medical Device
Distribution
3 states
ModerateFDA (Food)·H-0645-2026·2026-04-08
Prickly Pear Jelly recalled for undeclared milk allergen
The Maros Group, LLC has recalled Prickly Pear Jelly (9 oz glass bottles) sold in Arizona because the product contains undeclared milk. Consumers with milk allergies should not consume the affected product.
Product
Prickly Pear Jelly. 9 oz (268 g) glass bottle with gold cap.
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1658-2026·2026-04-08
BD Kiestra ReadA Lab System Connectivity May Be Lost After Reboot
BD Kiestra ReadA lab systems may temporarily lose remote connectivity after rebooting, potentially delaying plate retrieval. The issue is intermittent and does not affect test results, performance, or sample integrity.
Product
BD Kiestra" ReadA; Catalog No.: 446948.
Category
Medical Device
Distribution
6 states