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Recalls affecting Rhode Island

Data last updated: September 7, 2026 at 12:15 AM UTC

16,151 recalls found

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

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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/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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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

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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/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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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

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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)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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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/virusAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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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)
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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product Description: The ARVIS system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: " Total Knee Arthroplasty " Unicompartmental Knee Arthroplasty: Tibial Transverse Resection " Hip Arthroplasty The ARVIS" head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information. Component: NA

Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

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

Recall #:
99372
Lot/product code:
Lot Code: GMDN - 45200 UDI-DI - 00810180351287 Software ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Serial Number 6006A1118 6006A1036C3 6006A1117 6006A1045C2 6006A1106 6006A1126 6006A1149 6006A1034C2 6006A1046C2 6006A1086C2 6006A1093 6006A1079C3 6006A1096C2 6006A1052C2 6006A1058C3 6006A1030C2 6006A1088 6006A1100C 6006A1094 6006A1041C2 6006A1060C3 6006A1092C 6006A1105 6006A1140 6006A1040C2 6006A1090 6006A1116 6006A1109 6006A1037C2 6006A1053C3 6006A1102 6006A1108 6006A1120 6006A1155 6006A1127 6006A1139 6006A1095C2 6006A1131 6006A1132 6006A1142 6006A1152 6006A1193 6006A1194 6006A1208 6006A1209 6006A1107 6006A1064C 6006A1068C 6006A1081C 6006A1011C2 6006A1104 6006A1101 6006A1087C 6006A1075C 6006A1035C2 6006A1057C2 6006A1044C2 6006A1024C2 6006A1059C3 6006A1083C3 6006A1119 6006A1124 6006A1128 6006A1071C2 6006A1089 6006A1084 6006A1042C2 6006A1078C2 6006A1082C2 6006A1027C2 6006A1010C2 6006A1125 6006A1147 6006A1025C2 6006A1077C 6006A1076C
Recalling firm:
Kico Knee Innovation Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

ALL 50 STATES
▸Full report

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

Recall #:
99446
Lot/product code:
Lot U1/UDI: 00842768001048
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

ALL 50 STATES
▸Full report

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

Recall #:
99374
Lot/product code:
Model/UDI-DI/Serial Numbers: MMT-1711/00763000404550/NG2660048H, NG2663343H, NG3015306H; MMT-1712/00763000404567/NG2628486H, NG2758213H, NG2999651H, NG3349198H, NG3351719H, NG2678842H, NG2831821H, NG2831546H, NG2932027H, NG3049657H, NG3033094H, NG2831538H, NG3738739H
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

ALL 50 STATES
▸Full report

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

Recall #:
99374
Lot/product code:
Model/UDI-DI Serial Numbers: MMT-1781/00763000404536/NG2665223H, NG2748200H, NG2748664H, NG2755237H, NG2716176H, NG3547582H. MMT-1782/00763000404543/NG2768190H
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2026

Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.

Presence of Precipitate: medication was crystallizing and particles floating in the bottle

ALL 50 STATES
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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0724-2026
Lot/product code:
Lots: Batch # CR2518, Exp. 11/2027; Batch # CR2601, Exp. 12/2027; CR2602, CR2603, Exp. 01/2028; CR2604, CR2605, Exp. 02/2028.
Recalling firm:
Rising Pharma Holding, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

ALL 50 STATES
▸Full report

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

Recall #:
99374
Lot/product code:
Model/UDI-DI Serial Numbers: MMT-1885CLW/00763000442187, 00763000974374/NG3150737H, NG3155194H, NG3151561H, NG3154693H, NG3151716H, NG3153547H, NG3153637H, NG3155407H, NG3152666H, NG3155788H, NG3081975H, NG2901117H, NG3080842H, NG3081463H, NG3153416H, NG3081894H, NG3153781H, NG3155944H, NG3081982H, NG3081525H, NG3155909H, NG3090722H, NG3154897H, NG3088436H, NG3088708H, NG3090073H, NG3155908H, NG3150720H, NG3092957H, NG3128715H, NG3128784H, NG3152774H, NG3153929H, NG3514566H, NG3150780H, NG3151290H, NG3151508H, NG3507161H, NG3508693H, NG3081976H, NG3151460H, NG3152051H, NG3152085H, NG3152344H, NG3153213H, NG3152772H, NG3155586H, NG3150786H, NG3153214H, NG3153385H, NG3151840H, NG3082019H, NG3153405H, NG3153788H, NG3153908H, NG3154527H, NG3151598H, NG2854971H, NG3155196H, NG3155202H, NG3155341H, NG3091491H, NG3155557H, NG3081498H NG3155688H, NG3155020H, NG3508565H, NG3155419H, NG3507536H, NG3091563H, NG3082036H, NG3154689H, NG3154995H, NG3508504H, NG3514345H, NG3509850H, NG3527505H, NG3514547H, NG3527469H, NG3504333H, NG3504598H, NG3505071H, NG3505220H, NG3505273H, NG3514617H, NG3506727H, NG3085044H, NG3507542H, NG3507547H, NG3514448H, NG3508303H, NG3508350H, NG3508371H, NG3514612H, NG3508511H, NG3508617H, NG3508698H, NG3508707H, NG3508757H, NG3508799H, NG3508903H, NG3509138H, NG3509295H, NG3509299H, NG3509452H, NG3509685H, NG3509689H, NG3509836H, NG3509914H, NG3509925H, NG3514375H, NG3514441H, NG3505246H, NG3505166H, NG3505283H, NG3151570H, NG3154948H, NG3514667H, NG3527165H, NG3527243H, NG3527298H, NG3527468H, NG3527480H, NG3527491H, NG3527580H, NG3527529H, NG3527543H, NG3527571H, NG3527574H, NG3092722H, NG3527581H, NG3527611H, NG3527637H, NG3527642H, NG3527672H, NG3527710H, NG3527737H, NG3527760H, NG3527865H, NG3527918H, NG3527961H, NG3527989H, NG3528017H, NG3528023H, NG3528036H, NG3528061H, NG3528120H, NG3528147H, NG3528156H, NG3528158H, NG3528180H, NG3528218H, NG3528226H, NG3528378H, NG3539964H, NG3539969H, NG3539970H, NG3539999H, NG3540001H, NG3540013H, NG3540029H, NG3540046H, NG3540053H, NG3540084H, NG3540191H, NG3540270H, NG3540310H, NG3540320H, NG3540581H, NG3540604H, NG3540628H, NG3540629H MMT-1886CLW/00763000442194, 00763000974381/NG2966956H, NG2970938H, NG2986362H, NG3013390H, NG3057910H, NG3167493H, NG3466128H, NG3098147H, NG3136398H, NG3137113H, NG3139432H, NG3143920H, NG3144721H, NG3145486H, NG3145488H, NG3471528H, NG3167609H, NG3147120H, NG3147035H, NG3430059H, NG3438451H, NG3464758H, NG3163796H, NG3166778H, NG3409587H, NG3167450H, NG3167623H, NG3167967H, NG3169694H, NG3170253H, NG3321081H, NG3409583H, NG3409611H, NG3409656H, NG3409680H, NG3409697H, NG3409716H, NG3409807H, NG3409825H, NG3409831H, NG3409854H, NG3409925H, NG3409959H, NG3410005H, NG3410053H, NG3410092H, NG3410111H, NG3410166H, NG3410189H, NG3410227H, NG3410233H, NG3410243H, NG3410279H, NG3410304H, NG3410389H, NG3410398H, NG3429103H, NG3429377H, NG3429485H, NG3429881H, NG3430107H, NG3430448H, NG3437945H, NG3437957H, NG3438394H, NG3470788H, NG3466185H, NG3466619H, NG3466620H, NG3467368H, NG3467586H, NG3468759H, NG3469430H, NG3469907H, NG3470728H, NG3168104H, NG3472157H, NG3169669H, NG3170079H, NG3430111H, NG3429099H, NG3437621H, NG3167969H, NG3465813H, NG3167397H
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

ALL 50 STATES
▸Full report

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

Recall #:
99446
Lot/product code:
Lots: 2597, 2627, 2709/UDI: 00842768023293
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09); 3) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/SKU 780-13); 4) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Number/SKU 780-14); 5) HUDSON RCI, DBD-CIRCUIT, HTD, DUAL LIMB, NEONATE, Medline Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15); 6) HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD7801780-18) (Teleflex Product Number/SKU 780-18).

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

ALL 50 STATES
▸Full report

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

Recall #:
99403
Lot/product code:
1) Medline Product Number/SKU HUD78007, UDI/DI 10197344042463 (each) 20197344042460 (case), All lot numbers; 2) Medline Product Number/SKU HUD78009, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 3) Medline Product Number/SKU 780-13, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 4) Medline Product Number/SKU 780-14, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 5) Medline Product Number/SKU 780-15, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 6) Medline Product Number/SKU HUD78018, UDI/DI 10197344010660 (each) 20197344010667 (case), All lot numbers.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2026

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61

Weaker than it should be Drug

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-0707-2026
Lot/product code:
Bag lot #: N02212A, N02212B, Exp. Date 07/2026; Blister lot #: N02212, Exp. Date 07/2026
Recalling firm:
Major Pharmaceuticals
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2026

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61

Weaker than it should be Drug

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-0702-2026
Lot/product code:
Lot# N02172, exp 07/2026; N02296, N02288, Exp. Date 12/2026
Recalling firm:
Major Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

GM Helix Implant, Endosseous Dental Implant Article No. 109.984

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume

ALL 50 STATES
▸Full report

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

Recall #:
99407
Lot/product code:
UDI-DI 7899878024552 Lot MVXJ9
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT); 3) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT); 4) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-09KIT); 5) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78017KIT (Teleflex Product Number/SKU 780-17KIT); 6) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL HTD, DUAL LIMB,COLUMN, Medline Product Number/SKU HUD78018KIT (Teleflex Product Number/SKU 780-18KIT); 7) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD SINGLE LIMB,INFANT, Medline Product Number/SKU HUD88001KIT (Teleflex Product Number/SKU 880-01KIT); 8) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD,INFANT,HTD,COLUMN,DRN, Medline Product Number/SKU HUD88013KIT (Teleflex Product Number/SKU 880-13KIT); 9) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88014KIT (Teleflex Product Number/SKU 880-14KIT); 10) MEDLINE HUDSON RCI,ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88015KIT (Teleflex Product Number/SKU 880-15KIT); 11) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88017KIT (Teleflex Product Number/SKU 880-17KIT).

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

ALL 50 STATES
▸Full report

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

Recall #:
99403
Lot/product code:
1) Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT), UDI/DI 10197344010752 (each) 20197344010759 (case), All lot numbers; 2) Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT), UDI/DI 10197344010738 (each) 20197344010735 (case), All lot numbers; 3) Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT), UDI/DI 10197344010721 (each) 20197344010728 (case), All lot numbers; 4) Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-09KIT), UDI/DI 10197344010714 (each) 20197344010711 (case), All lot numbers; 5) Medline Product Number/SKU HUD78017KIT (Teleflex Product Number/SKU 780-17KIT), UDI/DI 10197344010677 (each) 20197344010674 (case), All lot numbers; 6) Medline Product Number/SKU HUD78018KIT (Teleflex Product Number/SKU 780-18KIT), UDI/DI 10197344010905 (each) 20197344010902 (case), All lot numbers; 7) Medline Product Number/SKU HUD88001KIT (Teleflex Product Number/SKU 880-01KIT), UDI/DI 10197344010929 (each) 20197344010926 (case), All lot numbers; 8) Medline Product Number/SKU HUD88013KIT (Teleflex Product Number/SKU 880-13KIT), UDI/DI 10197344010493 (each) 20197344010490 (case), All lot numbers; 9) Medline Product Number/SKU HUD88014KIT (Teleflex Product Number/SKU 880-14KIT), UDI/DI 10197344010486 (each) 20197344010483 (case), All lot numbers; 10) Medline Product Number/SKU HUD88015KIT (Teleflex Product Number/SKU 880-15KIT), UDI/DI 10197344010479 (each) 20197344010476 (case), All lot numbers; 11) Medline Product Number/SKU HUD88017KIT (Teleflex Product Number/SKU 880-17KIT), UDI/DI 10197344010462 (each) 20197344010469 (case), All lot numbers;
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

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

Recall #:
99433
Lot/product code:
UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z
Recalling firm:
OBP Medical Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2026

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61

Weaker than it should be Drug

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

Recall #:
D-0700-2026
Lot/product code:
Lot#: N02212, Exp. Date 07/2026
Recalling firm:
Major Pharmaceuticals
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2026

Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61

Weaker than it should be Drug

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

Recall #:
D-0704-2026
Lot/product code:
Lot #: N02203, Exp. Date 09/2026
Recalling firm:
Major Pharmaceuticals
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2026

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61

Weaker than it should be Drug

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

Recall #:
D-0709-2026
Lot/product code:
Bag lot #: N02172A, N02172B, Exp. Date 07/2026; N02288A, N02288B, Exp. Date 12/2026; Blister lot #: N02172, Exp. Date 07/2026; N02288, Exp. Date 12/2026
Recalling firm:
Major Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Innercool Coolblue Console, Model STx; Thermal regulating system.

Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down.

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

Recall #:
99478
Lot/product code:
UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
Recalling firm:
Gentherm Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2026

Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.

Kits contain a potentially contaminated component which were recalled by the manufacturer

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▸Full report

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

Recall #:
99507
Lot/product code:
Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26FMC710; Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26DMG417; Medline Kit SKU DYNJ911755, UDI/DI 10198459523946 (each) 40198459523947 (case), Lot Number 25KMI628; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 26ABJ549; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 26ABI899; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 25LBT433.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2026

Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F; 5) A P RESECTION, Medline Kit SKU DYNJ903467L.

Kits contain a potentially contaminated component which were recalled by the manufacturer

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▸Full report

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

Recall #:
99507
Lot/product code:
Medline Kit SKU CDS982273U, UDI/DI 10198459385827 (each) 40198459385828 (case), Lot Number 25LBR956; Medline Kit SKU CDS982273U, UDI/DI 10198459385827 (each) 40198459385828 (case), Lot Number 25KBP729; Medline Kit SKU CDS982654L, UDI/DI 10195327306830 (each) 40195327306831 (case), Lot Number 26EBN087; Medline Kit SKU CDS982662Q, UDI/DI 10195327306793 (each) 40195327306794 (case), Lot Number 25JBK543; Medline Kit SKU DYNJ54382F, UDI/DI 10198459794285 (each) 40198459794286 (case), Lot Number 26FMC227; Medline Kit SKU DYNJ903467L, UDI/DI 10198459293207 (each) 40198459293208 (case), Lot Number 26DMK551; Medline Kit SKU DYNJ903467L, UDI/DI 10198459293207 (each) 40198459293208 (case), Lot Number 26DMB880.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2026

Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

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

Recall #:
99504
Lot/product code:
Lot Number AOCIA6123
Recalling firm:
Paragon 28, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2026

Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.

Kits contain a potentially contaminated component which were recalled by the manufacturer

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▸Full report

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

Recall #:
99507
Lot/product code:
Medline Kit SKU DYNJ54362F, UDI/DI 10198459794292 (each) 40198459794293 (case), Lot Number 26EMF986; Medline Kit SKU DYNJ900957C, UDI/DI 10195327599461 (each) 40195327599462 (case), Lot Number 25IBP434; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 26BBA665; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25KBR602; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25JBH531; Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25KBL876; Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25JBS218.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2026

Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.

Kits contain a potentially contaminated component which were recalled by the manufacturer

ALL 50 STATES
▸Full report

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

Recall #:
99507
Lot/product code:
Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25LMF531; Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25JML577; Medline Kit SKU DYNJT6104, UDI/DI 10198459539374 (each) 40198459539375 (case), Lot Number 25JBM473; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26DDB085; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26DDA481; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26CDA102; Medline Kit SKU DYNJ906496K, UDI/DI 10198459419614 (each) 40198459419615 (case), Lot Number 25KLA074.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2026

Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.

Kits contain a potentially contaminated component which were recalled by the manufacturer

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▸Full report

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

Recall #:
99507
Lot/product code:
Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25LMF531; Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25JML577; Medline Kit SKU DYNJT6104, UDI/DI 10198459539374 (each) 40198459539375 (case), Lot Number 25JBM473; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26DDB085; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26DDA481; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26CDA102; Medline Kit SKU DYNJ906496K, UDI/DI 10198459419614 (each) 40198459419615 (case), Lot Number 25KLA074.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2026

Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline Kit SKU DYNJ900203N; 6) GYN LAPAROSCOPY, Medline Kit SKU DYNJ900541Q; 7) ROBOTIC, Medline Kit SKU DYNJ903485K; 8) ROBOTIC GYN, Medline Kit SKU DYNJ905230K; 9) LAPAROSCOPIC GYN AND COLON, Medline Kit SKU DYNJ906013I; 10) GYN LAPAROSCOPIC PACK, Medline Kit SKU DYNJ909394B; 11) GYN ROBOTIC, Medline Kit SKU DYNJ909526B; 12) GYN ROBOTIC, Medline Kit SKU DYNJ909526C; 13) GYN ONC ROBOTIC, Medline Kit SKU DYNJ910180; 14) GYN ROBOTIC, Medline Kit SKU DYNJ910181; 15) GYN ROBOTIC, Medline Kit SKU DYNJ910181A; 16) ROBOTICS, Medline Kit SKU DYNJ912062.

Kits contain a potentially contaminated component which were recalled by the manufacturer

ALL 50 STATES
▸Full report

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

Recall #:
99507
Lot/product code:
Medline Kit SKU CDS982888Q, UDI/DI 10198459521959 (each) 40198459521950 (case), Lot Number 26FBU894; Medline Kit SKU CDS982888Q, UDI/DI 10198459521959 (each) 40198459521950 (case), Lot Number 26BBF959; Medline Kit SKU DYNJ43837D, UDI/DI 10195327657222 (each) 40195327657223 (case), Lot Number 25KMH001; Medline Kit SKU DYNJ89759, UDI/DI 10198459289286 (each) 40198459289287 (case), Lot Number 26ABN671; Medline Kit SKU DYNJ89759, UDI/DI 10198459289286 (each) 40198459289287 (case), Lot Number 25JBT511; Medline Kit SKU DYNJ89781, UDI/DI 10198459289521 (each) 40198459289522 (case), Lot Number 26DBT722; Medline Kit SKU DYNJ89781, UDI/DI 10198459289521 (each) 40198459289522 (case), Lot Number 25JBL333; Medline Kit SKU DYNJ900203N, UDI/DI 10198459510144 (each) 40198459510145 (case), Lot Number 25KBF320; Medline Kit SKU DYNJ900203N, UDI/DI 10198459510144 (each) 40198459510145 (case), Lot Number 25JBS159; Medline Kit SKU DYNJ900541Q, UDI/DI 10198459602283 (each) 40198459602284 (case), Lot Number 26AMH304; Medline Kit SKU DYNJ900541Q, UDI/DI 10198459602283 (each) 40198459602284 (case), Lot Number 26AME001; Medline Kit SKU DYNJ903485K, UDI/DI 10198459255083 (each) 40198459255084 (case), Lot Number 26ADA977; Medline Kit SKU DYNJ903485K, UDI/DI 10198459255083 (each) 40198459255084 (case), Lot Number 25HDB674; Medline Kit SKU DYNJ905230K, UDI/DI 10198459520532 (each) 40198459520533 (case), Lot Number 25KBN172; Medline Kit SKU DYNJ906013I, UDI/DI 10198459501616 (each) 40198459501617 (case), Lot Number 25KBH190; Medline Kit SKU DYNJ909394B, UDI/DI 10198459556579 (each) 40198459556570 (case), Lot Number 25KBE469; Medline Kit SKU DYNJ909526B, UDI/DI 10198459539886 (each) 40198459539887 (case), Lot Number 26AMD191; Medline Kit SKU DYNJ909526C, UDI/DI 10198459716799 (each) 40198459716790 (case), Lot Number 26DMF990; Medline Kit SKU DYNJ910180, UDI/DI 10195327609627 (each) 40195327609628 (case), Lot Number 25IBP437; Medline Kit SKU DYNJ910181, UDI/DI 10195327609733 (each) 40195327609734 (case), Lot Number 25ILA566; Medline Kit SKU DYNJ910181A, UDI/DI 10198459556586 (each) 40198459556587 (case), Lot Number 25KLA664; DYNJ912062, UDI/DI 10198459611025 (each) 40198459611026 (case), Lot Number 26CBS107.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2026

Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330

Component labeling discrepancy

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

Recall #:
99506
Lot/product code:
UDI/DI 10198459582158 (each) 40198459582159 (case), Lot Number 26FLA408
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)