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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

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Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)

Recalls nationwide

Data last updated: September 10, 2026 at 1:16 PM UTC

19,408 recalls found
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 530G Insulin Pump (MMT-551, MMT-751)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 530G: 00643169507784, 00643169736061, 00643169736092, 00643169736085, 00643169933224, 00763000161170: Artwork, CRB A Process, Instr, 530G, One Press, Launch, US(MP6026081-012DOC); Artwork, CRB A Process, Instr, 530G, FDA comments, add TST(MP6025813-013DOC); Artwork, CRB A Process, Instr, 530G, Remove Velcro, Icons, US(MP6025813-014DOC);
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 13, 2026

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.

Failed Dissolution Specifications: This recall has been initiated due to an not meeting quality requirements finding in dissolution.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0341-2026
Lot/product code:
Lot # 49261, Exp: 04/30/27
Recalling firm:
AvKARE
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98464
Lot/product code:
REF:UDI-DI/Lot(Expiration): H965103028011/A:00884450793206/I3105589, I3115469, I3314948, I3343030; H965103028021/A:00884450793213/I2985084, I3235297, I3302100, I3343023; H965103028021/EU:00884450840733/I3254932; H965103028031/A:00884450786215/I2890967, I2909607, I2909610, I2909613, I2922255, I2928443, I2928445, I2973185, I2975817, I2979931, I2979932, I3010126, I3015730, I3015731, I3072562, I3108161, I3115487, I3120008, I3156395, I3161825, I3178917, I3202927, I3236144, I3236147, I3236157, I3236162, I3236164, I3368281; H965103028031/EU:00884450835326/I3219447, I3270828, I3288591; H965103028041/A:00884450786253/I2838431, I2910263, I2910264, I2910265, I2973186, I2975804, I2975805, I2979959, I2979960, I3015758, I3064923, I3064925, I3072563, I3108163, I3120003, I3120006, I3156399, I3165147, I3175748, I3178899, I3208677, I3236145, I3236148, I3236158, I3236163, I3236165, I3312321, I3315961, I3323271, I3347039; H965103028041/EU:00884450835333/I3217180, I3270829, I3302439; H965103028051/A:00884450793220/I2929337, I2997999, I3311219; H965103028051/EU:00884450840740/I3219448, I3270832, I3302440; H965103028061/A:00884450793237/I2920321, I2980492, I3154945, I3254911; H965103028061/EU:00884450835340/I3196140, I3270833, I3312332; H965103028070/A:00884450793244/I3015819, I3113237, I3170179, I3247943, I3288616; H965103028070/EU:00884450840757/I3255305, I3307483; H965103028080/A:00884450793251/I3002021, I306492, I3178919, I3302450, I3343031; H965103028080/EU:00884450840764/I3196137, I3302445, I3334625; H965103028090/A:00884450792353/I2920165, I3103138, I3178922, I3290565; H965103028090/EU:00884450840771/I3196135, I3302441, I3352493; H965103028161/A:00884450793268/I2914680, I2980457), I3098578; H965103028181/A:00884450793282/I2890978, I2902665, I2909617, I2909618, I2929338, I3076856, I3085067, I3098579, I3178915, I3254917, I3255301, I3283028; H965103028191/A:00884450793299/H2936911, I2870746, I2908636, I2909637, I2910257, I2920337, I2927199, I3144031, I3164176, I3219662, I3236146, I3288655, I3368110; H965103028191/EU:00884450835371/I3309111; H965103028201/A:00884450793305/I2973187, I3173621, I3178898), I3236149, I3288573; H965103028211/A:00884450793312/I2909764, I3144033, I3302435, I3343037; H965103028220/A:00884450793329/I2909788, I3394016; H965103028230/A:00884450793336/I2982337, I3044847, I3191920, I3288574, I3334623; H965103028240/A:00884450792360/I2929339, I3002035, I3049565, I3108165, I3254923, I3302451; H965103038181/A:00884450786314/I2890952, I2902661, I2902662
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98464
Lot/product code:
REF:UDI-DI/Lot: H787103028015/A:00884450794524/I3049562; H787103028025/A:00884450794531I3309371; H787103028031/A:00884450794548/I2929299, I3072553, I3154760, I3175731, I3178921, I3315957; H787103028035/A:00884450786130/I2910259, I2910261, I2910262, I2980545, I2995795, I3021388, I3076851, I3085062, I3219446, I3219454, I3255314, I3288649, I3334618; H787103028041/A:00884450794555/I2909647, I3115465, I3178909, I3236154; H787103028045/A:00884450786161/I3004072, I3015761, I3044845, I3072554, I3108153, I3176646, I3178918, I3213147, I3219456, I3281054, I3334627; H787103028051/A:00884450794562/I2995730, I3072556, I3213145, I3219455, I3288560, I3302443; H787103028055/A:00884450794579/I3178903); H787103028061/A:00884450794586/I2929300, I2995814, I3072557, I3165105, I3207168, I3236155, I3334619; H787103028075/A:00884450794609/I2995817), I3209313, I3270826; H787103028085/A:00884450794623/I2890956, I3072561, I3108155, I3288562, I3302444; H787103028095/A:00884450794630/I2909667, I2929315, I3021151, I3098576), I3219463, I3288581; H787103028165/A:00884450794647/I3049563; H787103028181/A:00884450794661/I2929317, I3178900, I3208675; H787103028185/A:00884450786178/I2927170, I2929318, I2929319, I3002050, I3015762, I3021450, I3049572, I3085060, I3173615, I3178896, I3195157; H787103028191/A:00884450794678/I2909758; H787103028195/A:00884450786185/I2890957, I2929321, I3021395, I3049573, I3076853, I3124837, I3169030, I3213148, I3236141, I3236161, I3302447, I3343042; H787103028205/A:00884450794692/I2927146, I2995766, I3015801, I3044846, I3144026, I3219464, I3288564, I3302448; H787103028215/A:00884450794708/I3178904; H787103028225/A:00884450794715/I3044836, I3108157, I3236142, I3315958; H787103028235/A:00884450842249/I3178905;
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98464
Lot/product code:
REF:UDI-DI/Lot: FCL-174-00/B:00884450522196/I2362705, I2370091, I2370711, I2370712, I2377840, I2377841, I2391548, I2397290, I2415120, I2417400, I2417401, I2417402, I2428656, I2428657, I2428658, I2428659, I2469204, I2469205, I2469206, I2469207, I2473119, I2485668, I2485669, I2485670, I2485671, I2485672, I2485673, I2485674, I2485675, I2496785, I2496787, I2496790, I2516610, I2516611, I2516612, I2516613, I2516614, I2516615, I2539710, I2539711, I2539713, I2539714, I2539715, I2539717, I2561078, I2561079, I2561081, I2561082, I2573969, I2606642, I2606643, I2606644, I2606645, I2619459, I2621646, I2621647, I2621648, I2621649, I2621650, I2621651, I2621652, I2621653, I2642738, I2642739, I2642740, I2644031, I2644032, I2644033, I2644034, I2644036, I2661872, I2661873, I2661874, I2661875, I2661876, I2661877, I2708121, I2708122, I2708123, I2708124, I2720071, I2720074, I2720075, I2720076, I2720077, I2720078, I2720079, I2729938, I2729939, I2729940, I2729941, I2729942, I2729943, I2729944, I2729945, I2759253, I2759254, I2759255, I2759256, I2759257, I2759258, I2759260, I2759261, I2759268, I2759269, I2781492, I2781493, I2781494, I2781495, I2781496, I2781497, I2781498, I2781499, I2788883, I2788884, I2788885, I2788886, I2788887, I2788888, I2788889, I2788890, I2788891, I2788892, I2810292, I2810293, I2810294, I2810296, I2810297, I2841474, I2841475, I2849305, I2849306, I2854355, I2854356, I2854357, I2860217, I2860218, I2861568, I2861569, I2871785, I2871786, I2871787, I2883689, I2883691, I2890983, I2904247, I2904250, I2927630, I2927631, I2942563, I2942564, I2942565, I2942566, I2942567, I2942568, I2942569, I2942570, I2942571, I2942667, I2942669, I2988895, I2988896, I2988897, I3013245, I3013246, I3075993, I3075994, I3075995, I3075996, I3075997, I3083308, I3083309, I3083310, I3083312, I3083314, I3083317, I3098214, I3098256, I3127468, I3138237, I3138238, I3138239, I3138240, I3138241, I3138242, I3159773, I3159774, I3159776, I3159777, I3186218, I3257331
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98464
Lot/product code:
REF:UDI-DI/Lot(Expiration): DC01455550/C:00884450697870/H2600169; DC21452419/C:00884450697900/H2659228: DC21452419-NE5/C:00884450697894/H3249278): DC21452823/C:00884450697924/H2600164, H2628890; DC21452823-NE5/C:00884450697917/H2990807: DC21453227/C:00884450697948/H2630602; DC21454035/C:00884450697962/H2628887: DC21455550/C:00884450697979/H2630553, H2659229
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98464
Lot/product code:
REF:UDI-DI/Lot: CENFP15K/A:00884450199992/H3357122; CENFP15K/B:00884450725917/H2797565; CENFP17K/A:00884450200001/H2643728, H2644554, H2755843, H2777866, H3357123; CENFP19K/A:00884450200018/H2415318, H2466455, H2466456, H2608337, H2632772, H2632921, H2643525, H2643729, H2658246, H2658395, H2663614, H2708827, H2777850, H2817064, H2817066, H2834183, H2834184, H2835774, H2875195, H2892153, H2900496, H2900649, H2918430, H2938756, H2982068, H2998532, H3019164, H3028009, H3089474, H3096774, H3101839, H3110067, H3123035, H3131873, H3139507, H3143969, H3152236, H3328470, H3332131, H3332133, H3357124, H3383280, H3398546; CENFP23K/A:00884450200025/H2368055, H2460265, H2543292, H2612929, H2622368, H2623456, H2631340, H2640771, H2663612, H2663613, H2719753, H2812164, H2817069,, H2834179, H2834181, H2847016, H2868174, H2880283, H2897527, H2900497, H2900550,, H2907334, H2911460, H2938761, H2978595, H2990699, H3004608, H3019163, H3049760,, H3049761 H3052479 H3071291 H3075039, H3089475, H3092914, H3096777, H3104588,, H3107507, H3120779, H3131874, H3143970, H3145117, H3191613, H3211721 H3316467,, H3328494, H3332218, H3332219, H3332220, H3351695;, CENFP27K/A:00884450200056/H2286892, H2480924, H2623453, H2643731, H2643732, H2653626, H2663616, H2777861, H2798003, H2833668, H2834185, H2880284, H2900619, H2907339, H2910719, H2911565, H2978601, H2986646, H2998508, H3004606, H3013812, H3019148, H3096779, H3110068, H3131879, H3143988, H3145119, H3156431, H3357125, H3383281; CENFT15K:00884450276068/H2845485,H2907340, H2911505, H2978606, H3004602; CENFT15K/D:00884450820766/ H3071303, H3075046, H3116838; CENFP31K/A:00884450200063/H2623455, H2643737, H2663617, H3052480, H3071293, H3071294, H3110069, H3113265, H3143998, H3196708, H3328496, H3332421; CENFT17K:00884450276082/H2750962, H2755782, H2777600, H3034899, H3059017, H3059018, H3062346; CENFT17K/A:00884450295526/H2911456; CENFT17K/D:00884450820773/H3139508; CENFT19K:00884450276105/H2632775, H2658397, H2709212, H2817067, H2821275, H2835372, H2856854, H2864393S1, H2884659, H2900500, H2907322, H2907349, H2918517, H2933863, H2937909, H2937910, H2978622, H2999167, H3019145, H3034898, H3049764; CENFT19K/A:00884450295540/H2907422; CENFT19K/B:00884450725993/H2801414; CENFT19K/D:00884450820780/H3049766, H3049767, H3071304, H3075050, H3089478, H3126999, H3144001, H3152238, H3156433, H3162590, H3179819, H3196714, H3221338, H3233980, H3239914, H3253651, H3261220, H3283451, H3306069, H3350849, H3357127, H3357128, H3365884, H3372112, H3398547; CENFT23K:00884450276129/H2368107, H2657097, H2709213, H2719652, H2783586, H2812165, H2834187, H2834188, H2864382S1, H2870049, H2892155, H2898665, H2900501, H2907365, H2911451, H2911452, H2934395, H2971862, H2986161, H2986162, H2998549, H3007025, H3019139, H3028000; CENFT23K/A:00884450295564/H2709157, H2817068, H2911454, H2990794, H3013830, H3019136, H3034895; CENFT23K/B:00884450726006/H2801413; CENFT23K/D:00884450820797/H3049771, H3049772, H3071305, H3071306, H3145122, H3152240, H3170518, H3196713, H3201956, H3211729, H3221345, H3233987, H3239915, H3249275, H3275167, H3301761, H3306072, H3323733, H3332225, H3342600; CENFT27K:00884450276143/H2618709, H2642807, H2783590, H2817065, H2835374, H2884649, H2892156, H2900227, H2910433, H2937927, H2949972, H2971939, H3019133, H3027993, H3059051, H3062349, H3071308; CENFT27K/A:00884450295588/H2831335, H2847031, H2911463, H3019129; CENFT27K/B:00884450726013/H2801412; CENFT27K/D:00884450820803/H3049776, H3049777, H3080509, H3152241, H3179811, H3186110, H3191615, H3201954, H3206164, H3301764, H3323734, H3342755, H3372113, H3385315; CENFT31K:00884450276167/H2821396, H2884650, H2900615, H2911536, H2933865, H2971861, H3003224, H3059059, H3059060, H3089477, H3101838; CENFT31K/A:00884450295601/H2938653, H3013843; CENFT31K/B:00884450726020/H2811536; CENFT31K/D:00884450820810/H3071085, H3071309, H3082414, H3144317, H3163092, H3179823, H3191620, H3206153, H3239916, H3249277, H3275168, H3283445, H3306075, H3323741
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 770G Insulin Pump: 763000456634, 763000414344, 763000413750, 763000545604, 763000586188, 763000642242, 763000926113, 763000482602, 763000416553, 763000439903, 763000416546, 763000439910, 763000629892, 763000629908, 00763000595906, 763000412685, 763000418151, 763000416546, 763000439903, 763000545499, 763000595906, 763000545505, 763000629892, 763000642235, 763000414344, 763000413750, 763000439866, 763000413750, 763000586195, 763000545604, 763000578640, 76300058618802, 76300058619501, 76300057864002, 76300054560402, 76300058619502, 763000926113: For MiniMed 770G System Users Ages 2-13(M010831C001 1); MiniMed 770G SYSTEM USER GUIDE(M984970A002 1, M978700A002 1, M030281C001 3, M030281C002 1, M811470A261 2, M984970A004 1, M020090C001 3, M020090C002 1, M020090C003 1, M998590A012 2, M998590A003 1, M998590A004 1); MiniMed 770G SYSTEM USER GUIDE mmol/L(M000039C021 1, M811470A021 2).
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 620G Insulin Pump (MMT-1750)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 620G Insulin Pump: 643169559745, 643169721319, 763000375461, 763000253189: Instr, Startup Guide, 620G 4.10, EN(6025951-022 1); INSTR., NGP 620G, BOLUS WIZARD, EN(6026006-023 1); Instr., 620G, Sftwr. 4.10, EN.(6026006-024 1); INSTRUCTIONS MMT-746EN PUMP 1510/1710 EN(7005933-023 1); DOC PKG MMT-746EN NGP 1710 EN(7005933-024 1); Startup Guide Assembly MMT-755EN(620G(M982438A021 1).
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 740G Insulin Pump: 763000504908, 763000504915, 763000505073, 763000484637, 763000505042, 763000504861, 763000629984, 763000504946, 763000504878, 763000559557, 763000504960, 763000505080, 763000505066, 763000629991, 763000505004, 763000504922, 763000504892, 763000505059, 763000504977, 763000505028, 763000505172, 763000505127, 763000505134, 763000505158, 763000505141, 763000505103, 763000505110, 763000504991, 763000505165, 763000504939, 763000504953, 763000504984, 763000505189, 763000851224, 763000851217, 763000769451, 763000769468: MINIMED 740G SYSTEM USER GUIDE mg/dL(M000149C002 1, M000149C004 1, M000149C005 1, M000150C005 1, M000150C002 1, M000150C021 2, M000149C016 1, M000149C021 1, M000150C004 1, M000150C025 1, M000150C030 1, M000149C014 1, M000149C006 1, M000150C003 1, M000150C015 1, M000150C028 1, M000150C018 1, M000150C022 1, M000150C007 1, M000149C017 1, M000149C008 1, M000150C008 1, M000150C032 1, M000150C029 1, M000150C012 1, M000150C016 1, M000150C010 1, M000149C011 1, M046726C001 3, M046726C002 3, M000149C020 1, M000149C025 1, M000150C024 1, M000150C023 1, M000150C013 1).
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 780G Insulin Pump: 763000411541, 763000441449, 763000523305, 763000521530, 763000521516, 763000533861, 763000544317, 763000734459, 763000758530, 763000758547, 763000578688, 763000734435, 763000504762, 763000734466, 763000924102, 763000924089, 763000454296, 763000854829, 763000411411, 763000411503, 763000384272, 763000411466, 763000411428, 763000411572, 763000411589, 763000411558, 763000384265, 763000411473, 763000411374, 763000411435, 763000411404, 763000384289, 763000411459, 763000411510, 763000411626, 763000411565, 763000411527, 763000411619, 763000411596, 763000411497, 763000411398, 763000411534, 763000411381, 763000384258, 763000411480, 763000411602, 763000411640, 763000411442, 763000441432, 763000442194, 763000521523, 763000442187, 763000521509, 763000521547, 763000578671, 763000596194, 763000639228, 763000639235, 763000639266, 763000974381, 763000974374, 763000921750, 763000921767, 763000921590, 763000921637, 763000933593, 763000891886, 763000921729, 763000921866, 763000921781, 763000921811, 763000921576, 763000921583, 763000921620, 763000921859, 763000891909, 763000921743, 763000944162, 763000921712, 763000921668, 763000933579, 763000933555, 763000933586, 763000933609, 763000921613, 763000933715, 763000933548, 763000944209, 763000891893, 763000933623, 763000933722, 763000933814, 763000933708, 763000933777, 763000933685, 763000933531, 763000933678, 763000933821, 763000933746, 763000933562, 763000944193, 763000533878, 763000734442, 763000854942, 763000914127: Medtronic MiniMed 780G with Instinct sensor System User Guide(M018856C024 2, M018857C035 2); Medtronic MiniMed 780G with Simplera Sync sensor System User Guide(M018857C034 2); Medtronic MiniMed 780G with Guardian 4 Sensor System User Guide(M028790C004 2, M028792C004 2); Medtronic MiniMed 780G with Guardian 4 Sensor System User Guide(M028792C015 1, M028792C001 3, M028792C002 1, M028792C006 1, M028792C003 1, M028792C005 1); Medtronic MiniMed 780G with Instinct sensor System User Guide(M018857C008 1, M018857C011 1, M018857C029 1, M018856C022 1, M018857C013 1, M018856C007 1, M018857C001 4, M018856C001 4, M018856C010 1, M018857C012 1, M018856C020 1, M018857C009 1, M018857C032 1, M018857C022 1, M018856C021 1, M018856C013 1, M018857C028 1, M018857C033 1, M018856C017 1, M018857C016 1, M018856C018 1); Medtronic MiniMed 780G with Simplera Sync sensor System User Guide(M018856C023 2, M018857C034 2); MiniMed 780G System Technical Guide(M075489C003 1, M075489C002 1, M075489C001 2); MiniMed 780G System User Guide(M072481C001 2); MiniMed 780G with Guardian 4 Sensor System User Guide mg(, M073070C003 1, M073070C001 2, M073070C002 1); MiniMed 780G with Guardian 4 Sensor System User Guide mm(M076019C002 1, M076019C001 1); MiniMed 780G with Guardian 4 Sensor System User Guide(M028790C003 1, M028790C002 1); MiniMed 780G system Changing the Medtronic Extended Infusion Set with Extended Reservoir(M048911C001 2, M048911C003 1, M048911C002 1); MiniMed 780G system Changing the MiniMed Mio Advance Infusion Set and Reservoir(M047607C001 1); MiniMed 780G system Changing the MiniMed Silhouette Infusion Set and Reservoir(M047610C001 1, M047610C003 1, M047610C002 1); MiniMed 780G system Changing the MiniMed Sure-T Infusion Set and Reservoir(M047609C001 1, M047609C003 1, M047607C003 1, M047607C002 1, M047609C002 1); MiniMed 780G System User Guide(M024832C003 2, M024829C004 2, M024832C004 2, M024829C005 2); MiniMed 780G System User Guide mg/dl(M014786C005 2, M014784C005 2, M014786C007 1, M014784C007 1, M014784C004 1, M014786C004 1, M014786C008 1, M014784C008 1, M014784C002 1, M014786C006 1, M014784C006 1, M014784C016 1, M014786C016 1, M014784C012 1, M014786C012 1, M014786C002 1, M014784C010 1, M014786C010 1, M014784C003 1, M014786C003 1, M014784C011 1, M014786C011 1, M014786C013 1, M014784C013 1, M014784C015 1, M014786C015 1, M014786C019 1, M014784C019 1); MiniMed 780G System User Guide mmol/L(M014787C002 1, M014785C002 1, M014785C007 2, M014787C007 1, M014787C005 1, M014785C005 1, M014787C006 1, M014785C006 1, M014785C023 2, M014787C023 2, M014787C010 1, M014785C010 1, M014787C011 1, M014785C011 1, M014787C021 1, M014785C021 1, M014787C008 1, M014785C008 1, M014785C009 1, M014787C009 1, M014787C022 1, M014785C022 1, M014785C027 1, M014787C027 1, M014787C004 2, M014785C004 2, M014785C003 1, M014787C003 1, M014785C030 1, M014787C030 1, M014785C013 2, M014787C013 2, M014785C019 1, M014787C019 1, M014785C020 1, M014787C020 1, M014787C018 1, M014785C018 1, M014787C012 1, M014785C012 1, M014787C016 1, M014785C016 1, M014787C024 1, M014785C024 1, M014785C014 2, M014787C014 1, M014787C028 1, M014785C028 1); MiniMed 780G with Guardian 4 Sensor System User Guide(M060264C012 1, M060263C011 1, M060264C018 1, M060263C015 1, M060264C017 1, M060263C014 1, M060264C006 1, M060264C004 1, M060263C001 3, M060263C016 1, M060264C007 1, M060264C008 1, M060264C009 1, M060264C010 1, M060264C011 1, M060264C001 3, M060… (truncated, 6690 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT

Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98524
Lot/product code:
1. UDI-DI 10198459016257 (ea) 40198459016258 (case) 2. UDI-DI 10193489860078 (ea) 40193489860079 (case) ALL LOTS
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 700G Insulin pump: 763000552541, 763000541323, 763000854737, 763000854720: MINIMEDTM 700 INSULIN PUMP USER GUIDE mmol/L(M984972A021 1); MINIMED 700 INSULIN PUMP USER GUIDE mg/dL(M015850C001 1).
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 630G Insulin Pump: 763000253066, 643169752726, 763000101527, 763000190446, 763000317591, 763000157043, 643169752726, 763000101527, 763000190446, 763000317591, 643169873841, 643169878648, 763000179632, 76300031759101, 76300031759103, 76300031762103, 763000367091, 763000317621, 763000157043, 76300031762101: MiniMed 630G System(M020092C004 1); MINIMED 630G and MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1); MiniMed 630G Insulin pump MODEL MMT-1714(M993428A262 1); MiniMed 630G System User Guide(M020092C001 3, M020092C003 1, M020092C005 1); MINIMED 630G SYSTEM USER GUIDE mg/dL(M979512A011 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(MP6026120-262 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(M030278C001 3, M030278C002 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE mmol/L (MP6026120-024 1); MiniMed Veo with Enlite Threshold Suspend Performance(M10577668A262 1).
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

Paradigm Insulin Pump (MMT-712, MMT-715)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Insulin Pump: 643169999770, 643169729360, 763000065201, 763000069001, 763000192228, 763000198602, 763000155346, 763000192143, 763000258344, 763000317140, 763000404567, 763000317188, 763000317195, 763000367046, 763000317157, 00613994470492, 00643169496262, 643169577664, 643169577688, 643169577695, 643169739512, 00613994332929, 00613994469694, 00613994470904, 00763000084271, 00763000161019, 643169577701, 643169739512, 643169662612, 00643169533776, 00763000084370, 643169656840, 763000090197, 763000190439, 763000316631, 00613994473820, 00643169478503, 00613994151766, 00643169710368, 00763000161057, 00613994326478, 00613994326508, 00613994395771, 00613994395719, 00613994395696, 00613994527851, 00643169729421, 00643169198920, 00643169572447, 00643169198890, 00613994527868, 00613994172129, 00613994172419, 00613994171627, 00613994171344, 00613994172211, 00613994172525, 00613994172334, 00613994172044, 00613994172761, 00613994171917, 00613994326621, 00613994326584, 00643169848825, 00643169848832, 00643169848801, 00613994395818, 00613994395764, 00613994395740, 00613994394132, 00763000069209, 00763000069179, 00613994527905, 00763000069162, 00613994527769, 00613994405876, 00763000069186, 00763000069148, 00613994527783, 00613994527806, 00613994527899, 00613994527790, 00613994527882, 00613994527837, 00643169198968, 00643169198883, 00643169198944, 00643169198906, 00763000084301, 00613994527745, 00643169198975, 00643169035515, 00643169201927, 00643169198913, 00643169198937, 00613994475268, 00643169198999, 00643169198982, 00643169503120, 00763000187507, 00643169198951, 00643169848818, 00643169848795, 00643169848771, 00613994527738, 00613994171443, 00613994171528, 00613994326539, 00613994326560, 00613994395726, 00613994395757, 00763000102616, 00763000069155, 00613994473868, 00763000004262, 00763000084318, 00763000161064, 76300031665503, 763000316655, 643169656840, 763000367053, 763000090197, 763000166519, 763000072520, 763000190439, 76300031665501, 763000316631, 763000256807: INSTR,US,FINE TUNING,PUMP,512/712 (6024948-012 3); INSTR,US,FINE TUNING,PUMP,PRDGM (6024948-013 1); INSTR,EN,FINE TUNING,PUMP (6024948-021 3); INSTR,US,PUMPS,PRDGM,515/715 (6025020-017 1); INSTR., 515/715, PRDGM, US (6025020-018 2); INSTR, 515/715, MDD, EN (6025020-024 1); INSTR, 515/715, EURO-E, MDD (6025020-025 2); INSTR., X15, EN OUS (6025020-026 1)
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 670G Insulin Pump: 643169946057, 763000096984, 763000090203, 763000165468, 763000190460, 763000190453, 763000216481, 763000187422, 763000187415, 763000165413, 763000165475, 763000367657, 763000289065, 763000264710, 763000283476, 763000283544, 763000283520, 763000283445, 763000393786, 763000289058, 763000374532, 763000283537, 763000365899, 763000371937, 763000283513, 763000165451, 763000165420, 763000165444, 763000165437, 763000165499, 763000165482, 763000165536, 763000165512, 763000165550, 763000165529, 763000235772, 763000165505, 763000235765, 763000165543, 763000257309, 763000283568, 763000283599, 763000289041, 763000289089, 763000289195, 763000289072, 763000289119, 763000289188, 763000289133, 763000289126, 763000289171, 763000289102, 763000404543, 763000289096, 763000289164, 763000404536, 763000324797, 763000264727, 763000324780, 763000283551, 763000283582, 763000374518, 763000374525, 763000374556, 763000374624, 763000374594, 763000374600, 763000399849, 763000399856, 763000408916, 763000408947, 763000371944, 763000365905, 763000374587, 763000408930, 763000283575, 763000157463, 763000203313, 763000252076, 763000283506, 763000411787, 643169946057, 763000096984, 763000190453, 763000283445, 763000395858, 763000278427, 763000090203, 763000283513, 763000365882, 763000283506, 76300028351303, 763000393786, 76300028351301, 763000166526, 643169939202, 763000190460, 763000283520, 763000072537, 763000256821, 643169939219, 763000187415, 763000283568: MiniMed670G System User Guide(M979513A011 1); MINIMED 630G and MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1); MINIMED 670G SYSTEM USER GUIDE(M988666A021 1, M979513A011 1, M985214A021 1, M985214A261 1, M974439A181 1, M974439A062 1, M974439A032 1, M974439A043 1, M974439A073 1, M974439A103 1, M974439A052 1, M020098C001 3, M020098C003 1, M974439A165 1, M974439A093 1, M974439A083 1); MINIMED 670G SYSTEM USER GUIDE mg/dL(M974449A111 1, M974449A073 1, M974449A103 1, M974449A023 1, M974449A093 1, M974449A083 1, M974449A113 1); MINIMED 670G SYSTEM USER GUIDE mmol/L(M974439A024 1).
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 720G Insulin Pump: 763000854768, 763000505196, 763000505219, 763000505318, 763000505257, 763000505295, 763000505233, 763000505370, 763000505325, 763000505332, 763000505394, 763000505356, 763000505387, 763000505349, 763000505400, 763000505226, 763000505271, 763000638016, 763000531171, 763000854751: MINIMED 720G SYSTEM USER GUIDE(M000187C022 1, M000186C002 1, M000186C014 1, M000187C016 1, M000186C021 1, M000186C018 1, M000186C017 1, M000187C010 1, M000187C011 1, M000186C031 1, M000187C013 1, M000187C008 1, M000187C015 1, M000187C005 1, M000187C033 1, M000186C028 1, M000187C023 1, M000187C020 1, M000187C018 1, M000186C018 13, M000186C004 1, M000186C030 1, M000186C009 1, M000187C024 1, M000186C033 1, M000186C003 1, M000187C012 1).
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusListeriaRecalled February 12, 2026

IQF frozen Blueberry (30lbs. cases and 1400 lbs. totes), product of USA. Product is packaged in polyethylene bag within a corrugated 30lbs. case or packaged in polyethylene liner within a Gaylord 1400lbs. tote. Frozen blueberries were not sold to consumers from retail stores. Willamette Valley Fruit Company 2994 82nd Ave. NE Salem OR 97305

Listeria monocytogenes

MIORWAWI
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0522-2026
Lot/product code:
Lot codes on 30 lbs. CASES: 2055 B2, 2065 B1, and 2065 B3. Lot codes on 1400 lbs. TOTES: 3305 A1 and 3305 B1. Expiration dates or best-by date: 2055 B2 expiration 7/23/2027 2065 B1 expiration 7/24/2027 2065 B3 expiration 7/24/2027 3305 A1 expiration 11/25/2027 3305 B1 expiration 11/25/2027
Recalling firm:
Oregon Potato Company LLC
Resolved:
August 27, 2026
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98371
Lot/product code:
Model Number: MAJ-1444. UDI-DI: 04953170355929. Catalog number: N5363530. All Lot/Serial Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98371
Lot/product code:
Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98371
Lot/product code:
Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusListeriaRecalled February 12, 2026

IQF Blueberry (30lbs. cases and 1400 lbs. totes), product of USA. Product is packaged in polyethylene bag within a corrugated 30lbs. case or packaged in polyethylene liner within a Gaylord 1400lbs. tote. Product was not sold to consumers from retail stores. Willamette Valley Fruit Company 2994 82nd Ave. NE Salem OR 97305

Listeria monocytogenes

MIORWAWI
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0522-2026
Lot/product code:
Lot codes on 30 lbs. CASES: 2055 B2, 2065 B1, and 2065 B3. Lot codes on 1400 lbs. TOTES: 3305 A1 and 3305 B1. Expiration dates or best-by date: 2055 B2 expiration 7/23/2027 2065 B1 expiration 7/24/2027 2065 B3 expiration 7/24/2027 3305 A1 expiration 11/25/2027 3305 B1 expiration 11/25/2027
Recalling firm:
Oregon Potato Company LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled February 12, 2026

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80

Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.

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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0343-2026
Lot/product code:
All lots within expiry
Recalling firm:
Slate Run Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98371
Lot/product code:
Model Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. All Lot/Serial Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

Probes may rupture/burst during activation

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98429
Lot/product code:
UDI: 04050147021846/ Expanded Lots:WO472498 WO472499 WO472615 WO472616 WO473794 WO473795 WO474908 WO474909 WO474910 WO475357 WO475358 WO477030 WO477513 WO477514 WO478643 WO478646 WO478647 WO478648 WO478843 WO478844;Initial Lots: WO461840 WO461846 WO462097 W2462284 WO463327 WO463328 WO463388 W2463594 WO464285 WO464286 WO465063 WO465064 W4465351 W2465601 W2465689 W2465749 W2465769 WO467873 WO467874 WO467875 WO468648 WO468649 WO469364 W2459861 W2459862 W2459863
Recalling firm:
Erbe USA Inc
View official FDA record (opens in a new tab)