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Recalls affecting New Hampshire

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

16,438 recalls found
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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

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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/virusSalmonellaAnnounced 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

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UnclassifiedBacteria/virusE. coliAnnounced 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

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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)
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)

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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

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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.

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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

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UnclassifiedBacteria/virusSalmonellaAnnounced 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

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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJ59030B, UDI-DI: 10198459176920(each), 40198459176921(case), Lot Number: 24KBL574; 2) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24IBJ666; 3) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24JBM014; 4) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24KBE220; 5) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24LBJ174; 6) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25ABW145; 7) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25CBK525; 8) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25EBA897; 9) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25GBK561; 10) VASC1081C, UDI-DI: 10195327054519(each), 40195327054510(case), Lot Number: 25FBA927
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
▸Full report

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

Recall #:
98599
Lot/product code:
1) DYNJ41648A, UDI-DI: 10198459062834(each), 40198459062835(case), Lot Number: 25CLA242; 2) DYNJ41648A, UDI-DI: 10198459062834(each), 40198459062835(case), Lot Number: 24LLA758
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT5717; 7) HEART CATH PACK, Model Number: DYNJ0381139R; 8) CARDIAC CATH PACK, Model Number: DYNJ04529L; 9) CUSTOM RADIOLOGY PACK, Model Number: DYNJ07955L; 10) STVZ CARDIAC CATH PACK, Model Number: DYNJ24619J; 11) CATH TRAY #2, Model Number: DYNJ24706D; 12) CATH LAB PACK, Model Number: DYNJ24802Q; 13) CATH PACK, Model Number: DYNJ30268K; 14) HEART CATHETERIZATION PACK, Model Number: DYNJ30927R; 15) HEART CATH TRAY PACK-LF, Model Number: DYNJ31944D; 16) CATH PACK-LF, Model Number: DYNJ33061D; 17) CATH PACK, Model Number: DYNJ34638K; 18) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ38120C; 19) CATH PACK, Model Number: DYNJ40904G; 20) CARDIAC CATH-LF, Model Number: DYNJ41057D; 21) CATH LAB PACK, Model Number: DYNJ41172; 22) ANGIOGRAPHY PACK, Model Number: DYNJ42134G; 23) CATH LAB DRAPE PACK, Model Number: DYNJ42455B; 24) ANGIOGRAPHY PACK, Model Number: DYNJ42543B; 25) CATH LAB PACK, Model Number: DYNJ42900D; 26) ANGIOGRAPHY PACK NO SYR, Model Number: DYNJ43009K; 27) CATH PACK (WITH MANIFOLD), Model Number: DYNJ44515L; 28) ANGIO IR DRAPE PACK 319696, Model Number: DYNJ44593I; 29) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 30) CATH LAB PACK, Model Number: DYNJ45296; 31) ANGIO PACK, Model Number: DYNJ50739J; 32) CARDIAC CATH PACK, Model Number: DYNJ51103F; 33) IR ANGIO BODY, Model Number: DYNJ51765D; 34) INTERVENTIONAL TRAY, Model Number: DYNJ52501C; 35) CARDIAC CATH IMF 86040- LF, Model Number: DYNJ53947J; 36) CARDIAC CATH PACK, Model Number: DYNJ54101I; 37) ANGIO KIT, Model Number: DYNJ55686C; 38) CATH LAB PACK, Model Number: DYNJ56141B; 39) ANGIO NEURO PACK, Model Number: DYNJ57685D; 40) CATH PACK, Model Number: DYNJ57729F; 41) CATH PACK, Model Number: DYNJ59632F; 42) CATH LAB PACK WITH NAMIC, Model Number: DYNJ60853D; 43) ANGIO PACK ALEX, Model Number: DYNJ63539C; 44) ANGIOGRAPHY CV RAD PACK, Model Number: DYNJ64936B; 45) CATH LAB PACK, Model Number: DYNJ65185D; 46) CATH PACK, Model Number: DYNJ65619A; 47) CATH I W SPLIT DRAPE PACK, Model Number: DYNJ66182; 48) CATH PACK SHD, Model Number: DYNJ68384B; 49) CATH LAB PACK, Model Number: DYNJ69094B; 50) CATH LAB ACCESSORIES, Model Number: DYNJ69213B; 51) REYES CATH PACK, Model Number: DYNJ69345A; 52) TMH ANGIOGRAPHY TRAY, Model Number: DYNJ80054A; 53) ANGIOGRAPHY TRAY, Model Number: DYNJ80156; 54) CATH PACK, Model Number: DYNJ80516C; 55) CATH PACK, Model Number: DYNJ80730; 56) ANGIO DRAPE PACK 2 WINDOW, Model Number: DYNJ81066B; 57) OR ANGIOGRAM PACK, Model Number: DYNJ81435F; 58) HEART CATH PACK, Model Number: DYNJ81527B; 59) HEART CATH PACK, Model Number: DYNJ83764D; 60) CATH LAB PACK, Model Number: DYNJ84048A; 61) ANGIO TRAY NO LIDO, Model Number: DYNJ85557B; 62) CARDIAC CATH PACK, Model Number: DYNJ85746B; 63) ANGIOGRAPHY PACK, Model Number: DYNJ86313; 64) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ86787; 65) CATH PACK, Model Number: DYNJ87098A; 66) CATH LAB TAVR PACK, Model Number: DYNJ88532; 67) SMT LEFT HEART CATH, Model Number: DYNJ89274; 68) VASCULAR CATH PACK, Model Number: DYNJ89352; 69) CATH LAB PACK, Model Number: DYNJ89805; 70) CARDIAC CATH MERCY WASHINGTON, Model Number: DYNJ89934; 71) ANGIO, Model Number: DYNJ900278G; 72) TAVR ICC VER. F, Model Number: DYNJ904401F; 73) TAVR, Model Number: DYNJ908646C; 74) LHK-UPMC CHILDRENS MAIN OR 2, Model Number: NAM0009; 75) KIT ANGIO CSTM-EVERGREEN, Model Number: NAM0020; 76) GP-CARDIAC CATH PACK-LF, Model Number: PHS397170009D; 77) LEFT HEART KIT - MARION, Model Number: VASC1073A; 78) RHK - VAMC RICHMOND, Model Number: VASC1185B; 79) LHK-MEADOWVIEW REG, Model Number: VASC1263; 80) LHK - BSC 3V ON S10RA, Model Number: VASC1269; 81) LHK - BSC 3V ON S10MLL, Model Number: VASC1270; 82

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
▸Full report

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

Recall #:
98599
Lot/product code:
1) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 25ALA420; 2) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 25CLA774; 3) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 24LLA038; 4) DYNDH2104, UDI-DI: 10198459273964(each), 40198459273965(case), Lot Number: 25DBR609; 5) DYNJT2164M, UDI-DI: 10198459003165(each), 40198459003166(case), Lot Number: 24JBT885; 6) DYNJT3078, UDI-DI: 10198459305146(each), 40198459305147(case), Lot Number: 25DBN722; 7) DYNJT4190, UDI-DI: 10198459428234(each), 40198459428235(case), Lot Number: 25HBA387; 8) DYNJT5717, UDI-DI: 10198459496684(each), 40198459496685(case), Lot Number: 26ALA778; 9) DYNJ0381139R, UDI-DI: 10198459276019(each), 40198459276010(case), Lot Number: 25JLA029; 10) DYNJ04529L, UDI-DI: 10198459391460(each), 40198459391461(case), Lot Number: 25JLA312; 11) DYNJ07955L, UDI-DI: 10889942628896(each), 40889942628897(case), Lot Number: 24HBM316; 12) DYNJ07955L, UDI-DI: 10889942628896(each), 40889942628897(case), Lot Number: 23HBX895; 13) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 23DBP876; 14) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 23FBG933; 15) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24GBE563; 16) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24HBT787; 17) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24KBC564; 18) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24LBL445; 19) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 25DBF355; 20) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 25EBG106; 21) DYNJ24706D, UDI-DI: 10889942297122(each), 40889942297123(case), Lot Number: 25BBB510; 22) DYNJ24802Q, UDI-DI: 10198459091476(each), 40198459091477(case), Lot Number: 25DBJ212; 23) DYNJ30268K, UDI-DI: 10198459132636(each), 40198459132637(case), Lot Number: 25EMH059; 24) DYNJ30268K, UDI-DI: 10198459132636(each), 40198459132637(case), Lot Number: 25FMA010; 25) DYNJ30268K, UDI-DI: 10198459132636(each), 40198459132637(case), Lot Number: 25GME803; 26) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 24JME497; 27) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25AME060; 28) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25CMA483; 29) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25CMI507; 30) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25DMB230; 31) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25DMF455; 32) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25EMB900; 33) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25EMI646; 34) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 23JBA288; 35) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 23JBB352; 36) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 23LBC983; 37) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24ABR897; 38) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24EBQ350; 39) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24FBM413; 40) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24GBA097; 41) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24HBU538; 42) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24IBM289; 43) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24JBJ568; 44) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24LBL092; 45) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 25CBF566; 46) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 25DBG717; 47) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24ABR608; 48) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 25EBA519; 49) DYNJ33061D, UDI-DI: 10193489841428(each), 40193489841429(case), Lot Number: 25BBJ181; 50) DYNJ34638K, UDI-DI: 10195327630614(each), 40195327630615(case), Lot Number: 25LLA963; 51) DYNJ38120C, UDI-DI: 10193489979398(each), 40193489979399(case), Lot Number: 23JBL270; 52) DYNJ38120C, UDI-DI: 10193489979398(each), 40193489979399(case), Lot Number: 23HBW572; 53) DYNJ40904G, UDI-DI: 10195327650117(each), 40195327650118(case), Lot Number: 25ABD202; 54) DYNJ40904G, UDI-DI: 10195327650117(each), 40195327650118(case), Lot Number: 25CBK291; 55) DYNJ40904G, UDI-DI: 10195327650117(each), 40195327650118(case), Lot Number: 25EBB772; 56) DYNJ40904G, UDI-DI: 10195327650117(each), 40195327650118(… (truncated, 42503 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number: DYNJ53591A; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
▸Full report

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

Recall #:
98599
Lot/product code:
1) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 23KBL880; 2) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 24ABA125; 3) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 23IBA898; 4) DYNJT2021G, UDI-DI: 10193489608816(each), 40193489608817(case), Lot Number: 24CMH245; 5) DYNJ31377B, UDI-DI: 10889942106691(each), 40889942106692(case), Lot Number: 25LBQ639; 6) DYNJ31377B, UDI-DI: 10889942106691(each), 40889942106692(case), Lot Number: 25GBF384; 7) DYNJ51279, UDI-DI: 10889942145300(each), 40889942145301(case), Lot Number: 25DBQ486; 8) DYNJ51279, UDI-DI: 10889942145300(each), 40889942145301(case), Lot Number: 25CBT538; 9) DYNJ52447, UDI-DI: 10889942279777(each), 40889942279778(case), Lot Number: 25FMA232; 10) DYNJ53369C, UDI-DI: 10193489651331(each), 40193489651332(case), Lot Number: 25ILA917; 11) DYNJ53369C, UDI-DI: 10193489651331(each), 40193489651332(case), Lot Number: 25FLA554; 12) DYNJ53591A, UDI-DI: 10889942592371(each), 40889942592372(case), Lot Number: 25FBA222; 13) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21JBN533; 14) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21KBM563; 15) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21KBQ110; 16) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21LBI454; 17) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23DMF559; 18) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23EMB053; 19) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23FME913; 20) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23JME012; 21) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24BMK272; 22) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24CMK043; 23) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24CMK043Z; 24) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24DMJ156; 25) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24FMI064; 26) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24HMB643; 27) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24JME212; 28) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23HME551; 29) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 25DMB495; 30) DYNJ58722A, UDI-DI: 10193489329698(each), 40193489329699(case), Lot Number: 25GBS720; 31) DYNJ62742, UDI-DI: 10193489685923(each), 40193489685924(case), Lot Number: 24KBE607; 32) DYNJ67876, UDI-DI: 10193489449198(each), 40193489449199(case), Lot Number: 25KBP615; 33) VASC1170A, UDI-DI: 10193489774863(each), 40193489774864(case), Lot Number: 23GMC436
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
▸Full report

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

Recall #:
98599
Lot/product code:
1) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22IBH073; 2) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22IBH620; 3) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22KBU236; 4) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22LBB186; 5) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23BBE163; 6) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23BBQ244; 7) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23BBT094; 8) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23CBN156; 9) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23DBO047; 10) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23EBN965; 11) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23FBG730; 12) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23HBL275; 13) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24BBT133; 14) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24DBC913; 15) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24DBM253; 16) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24EBD055; 17) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24EBM619; 18) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24FBC811; 19) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24GBO792; 20) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24HBQ429; 21) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24KBO162; 22) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25ABL984; 23) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25ABV250; 24) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25BBC496; 25) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25BBS716; 26) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25BBU979; 27) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25CBB632; 28) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25CBC880; 29) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25CBN329; 30) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22JBU981; 31) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23FBP998; 32) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24JBO656; 33) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25DBR721; 34) VASCSLPOFF1, UDI-DI: 10889942405527(each), 40889942405528(case), Lot Number: 24KBI875; 35) VASCSLPOFF1, UDI-DI: 10889942405527(each), 40889942405528(case), Lot Number: 23KBD992; 36) VASC1018A, UDI-DI: 10889942337033(each), 40889942337034(case), Lot Number: 25BBG137; 37) VASC1018A, UDI-DI: 10889942337033(each), 40889942337034(case), Lot Number: 25BBI161; 38) VASC1018A, UDI-DI: 10889942337033(each), 40889942337034(case), Lot Number: 25ABG686
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
▸Full report

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

Recall #:
98599
Lot/product code:
1) DYNJ41254B, UDI-DI: 10888277882003(each), 40888277882004(case), Lot Number: 25FBA224
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6) SYRINGE 8ML CONTROL MLL, Model Number: DYNJSYR8C; 7) SYRINGE 12ML CONTROL MLL, Model Number: DYNJSYR12C; 8) SYR CONTROL PAD 10ML L/L ROT, Model Number: DYNJSYR10CRP; 9) SYR CONTROL PAD 12ML L/L ROT, Model Number: DYNJSYR12CRP; 10) CTRL SYRINGE 6ML RING ROT L/L, Model Number: DYNJSYRC6CWR

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
▸Full report

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

Recall #:
98599
Lot/product code:
1) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25ABF227; 2) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25CBC537; 3) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25EBK855; 4) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDA120; 5) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDA552; 6) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDA648; 7) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDB507; 8) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25EBH091; 9) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25EBO178; 10) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25IDA686; 11) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25JDA207; 12) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25JDB599; 13) DYNJSYR12CP, UDI-DI: 10888277236615(each), 40888277236616(case), Lot Number: 25GBD528; 14) DYNJSYR12CP, UDI-DI: 10888277236615(each), 40888277236616(case), Lot Number: 25JDB601; 15) DYNJBRT72R, UDI-DI: 10884389854211(each), 40884389854212(case), Lot Number: 25GBN402; 16) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBS345; 17) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBS857; 18) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBU045; 19) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBV139; 20) DYNJSYR8C, UDI-DI: 10884389676493(each), 40884389676494(case), Lot Number: 25IDB505; 21) DYNJSYR12C, UDI-DI: 10884389676479(each), 40884389676470(case), Lot Number: 25IDB506; 22) DYNJSYR12C, UDI-DI: 10884389676479(each), 40884389676470(case), Lot Number: 25JDA208; 23) DYNJSYR12C, UDI-DI: 10884389676479(each), 40884389676470(case), Lot Number: 25JDB827; 24) DYNJSYR10CRP, UDI-DI: 10888277236585(each), 40888277236586(case), Lot Number: 25JDA594; 25) DYNJSYR12CRP, UDI-DI: 10888277236592(each), 40888277236593(case), Lot Number: 25JDB600; 26) DYNJSYRC6CWR, UDI-DI: 10889942885732(each), 40889942885733(case), Lot Number: 25JDB602
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115; 5) GWIRE HYDRO 0.035 150CM STR, Model Number: DYNJHWIRE108; 6) GWIRE HYDRO 0.035 150CM ANG S, Model Number: DYNJHWIRE104; 7) GWIRE HYDRO 0.035 180CM STR S, Model Number: DYNJHWIRE113; 8) GWIRE HYDRO 0.035 260CM ANGLE, Model Number: DYNJHWIRE103; 9) GDWIRE .035INX150CM 3MMJ LT, Model Number: DYNJGWIRE01L; 10) GDWIRE .035INX180CM 3MMJ LT, Model Number: DYNJGWIRE03L; 11) GWIRE HYDRO 0.035 150CM STR S, Model Number: DYNJHWIRE112; 12) GWIRE HYDRO 0.035 180CM STR, Model Number: DYNJHWIRE109; 13) GWIRE HYDRO 0.035 210CM ANGLE, Model Number: DYNJHWIRE102; 14) GWIRE HYDRO 0.035 210CM ANG S, Model Number: DYNJHWIRE106; 15) GWIRE HYDRO 0.035 210CM STR, Model Number: DYNJHWIRE110; 16) GWIRE,HYDRO,0.038,180CM,ANG S, Model Number: DYNJHWIRE121; 17) GWIRE HYDRO 0.038 210CM ANG S, Model Number: DYNJHWIRE122; 18) GWIRE HYDRO 0.038 210CM ANGLE, Model Number: DYNJHWIRE118; 19) GWIRE HYDRO 0.038 260CM STR, Model Number: DYNJHWIRE127; 20) GWIRE,HYDRO,0.038,210CM,STR S, Model Number: DYNJHWIRE130; 21) GWIRE,HYDRO,0.038,260CM,ANG S, Model Number: DYNJHWIRE123; 22) GWIRE,HYDRO,0.038",150CM,STR, Model Number: DYNJHWIRE124; 23) GWIRE HYDRO 0.038 150CM ANGLE, Model Number: DYNJHWIRE116; 24) GWIRE,HYDRO,0.038",210CM,STR, Model Number: DYNJHWIRE126; 25) GWIRE HYDRO 0.035 260CM STR, Model Number: DYNJHWIRE111; 26) GWIRE HYDRO 0.035 150CM ANGLE, Model Number: DYNJHWIRE100; 27) GWIRE HYDRO 0.035 180CM ANGLE, Model Number: DYNJHWIRE101; 28) GWIRE,HYDRO,0.038",180CM, STR, Model Number: DYNJHWIRE125; 29) GWIRE HYDRO 0.038 260CM ANGLE, Model Number: DYNJHWIRE119; 30) GWIRE HYDRO 0.038 150CM ANG S, Model Number: DYNJHWIRE120

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
▸Full report

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

Recall #:
98599
Lot/product code:
1) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125030001; 2) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125040001; 3) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBG562; 4) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBM956; 5) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 34124110001; 6) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 24LBR925; 7) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 25IDB410; 8) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 34124110001; 9) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23IBI440; 10) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23KBI254; 11) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABQ057; 12) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABR513; 13) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24GBL513; 14) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 25JDA853; 15) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 34124110001; 16) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 23BBI300; 17) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24DBT361; 18) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24LBN513; 19) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 34124110001; 20) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBG409; 21) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBI536; 22) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBV499; 23) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 34124110001; 24) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 23BBE325; 25) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24DBF377; 26) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24DBP677; 27) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24EBT215; 28) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24FBB651; 29) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24GBN276; 30) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 25JDB022; 31) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 34124110001; 32) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 23BBI328; 33) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 23EBX142; 34) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 24CBI166; 35) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 24EBB935; 36) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 34125010001; 37) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24CBP092; 38) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24GBQ708; 39) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24LBN511; 40) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 25IDB409; 41) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 34125030001; 42) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 34125040001; 43) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25HDB501; 44) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25JDA596; 45) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25JDA852; 46) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 34125030001; 47) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25IDA121; 48) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDA209; 49) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDA844; 50) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDB021; 51) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23BBC807; 52) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23EBF993; 53) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23EBX235; 54) DYNJHWIRE109, UDI-DI: 10195327302207(each), 40195327302208(case), Lot Number: 23BBI326; 55) D… (truncated, 8857 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
▸Full report

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

Recall #:
98599
Lot/product code:
1) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBK394; 2) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBN659; 3) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBO446; 4) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBO586; 5) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBQ523
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

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

Recall #:
98461
Lot/product code:
Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.
Recalling firm:
Synthes (USA) Products LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

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

Recall #:
98599
Lot/product code:
1) CDS930027Y, UDI-DI: 10198459303128(each), 40198459303129(case), Lot Number: 25EBE671
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

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

Recall #:
98454
Lot/product code:
Model: 3005; UDI: 00821925035881; Lot Number: All unexpired
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

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

Recall #:
98599
Lot/product code:
1) DYNJ82440, UDI-DI: 10195327196240(each), 40195327196241(case), Lot Number: 24BMD005
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245; 6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247; 7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928; 8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011; 9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273; 10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268; 11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097; 12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387; 13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435; 14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521; 15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743; 16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078; 17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542; 18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071; 19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254; 20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439; 21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773; 22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099; 23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653; 24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326; 25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148; 26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428; 27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135; 28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618; 29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531; 30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137; 31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661; 32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662; 33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001; 34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432; 35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312; 36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273; 37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202; 38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189; 39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014; 40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047; 41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503; 42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527; 43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712; 44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412; 45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712; 46) MTS PEDS LFT RT HRT-SUNRISE HO, Model Number: 601905414; 47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072; 48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361; 49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411; 50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921; 51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581; 52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001; 53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A; 54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D; 55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B; 56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D; 57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C; 58) ANGIO TRAY, Model Number: DYNJ43278C; 59) CARDIAC LEG PACK, Model Number: DYNJ44065C; 60) EP PACK, Model Number: DYNJ55512A; 61) VASCULAR PACK, Model Number: DYNJ58522A; 62) PERIPHERAL CATH, Model Number: DYNJ59220C; 63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A; 64) C V MINOR PACK, Model Number: DYNJ64862B; 65) ENDOVASCULAR PACK, Model Number: DYNJ65926

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

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

Recall #:
98599
Lot/product code:
1) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 183372; 2) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 185190; 3) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 106008; 4) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 117378; 5) 60022673, UDI-DI: 10193489041538(each), 20193489041535(case), Lot Number: 176180; 6) 60030817, UDI-DI: 10193489041972(each), 20193489041979(case), Lot Number: 185193; 7) 60031245, UDI-DI: 10193489042214(each), 20193489042211(case), Lot Number: 183374; 8) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 174370; 9) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 184424; 10) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 185080; 11) 60031928, UDI-DI: 10193489042276(each), 20193489042273(case), Lot Number: 185195; 12) 60033011, UDI-DI: 10193489042429(each), 20193489042426(case), Lot Number: 181365; 13) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 179872; 14) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 183375; 15) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 140365; 16) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 170084; 17) 60050097, UDI-DI: 10193489043242(each), 20193489043249(case), Lot Number: 176186; 18) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 183376; 19) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 185194; 20) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 187370; 21) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 183377; 22) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 187371; 23) 60070521, UDI-DI: 10193489044164(each), 20193489044161(case), Lot Number: 185196; 24) 60071743, UDI-DI: 10193489044348(each), 20193489044345(case), Lot Number: 176190; 25) 60090078, UDI-DI: 10193489044829(each), 20193489044826(case), Lot Number: 185197; 26) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 181373; 27) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 185198; 28) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 176193; 29) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 185189; 30) 60100254, UDI-DI: 10193489045024(each), 20193489045021(case), Lot Number: 185188; 31) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 181369; 32) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 185203; 33) 60101773, UDI-DI: 10193489045451(each), 20193489045458(case), Lot Number: 181364; 34) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 181370; 35) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 185204; 36) 60132653, UDI-DI: 10193489047332(each), 20193489047339(case), Lot Number: 181381; 37) 60138326, UDI-DI: 10193489047653(each), 20193489047650(case), Lot Number: 185205; 38) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 183382; 39) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 185207; 40) 60160428, UDI-DI: 10193489048773(each), 20193489048770(case), Lot Number: 181100; 41) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 177936; 42) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 185208; 43) 60163618, UDI-DI: 10193489049251(each), 20193489049258(case), Lot Number: 140392; 44) 60181531, UDI-DI: 10193489049619(each), 20193489049616(case), Lot Number: 185209; 45) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 185522; 46) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 187343; 47) 60182661, UDI-DI: 10193489049794(each), 20193489049791(case), Lot Number: 176203; 48) 60183662, UDI-DI: 10193489050080(each), 20193489050087(case), Lot Number: 181371; 49) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 177939; 50) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 185210; 51) 60185432, UDI-DI: 10193489050325(each), 20193489050322(case), Lot Number: 184739; 52) 60191312, UDI-DI: 10193489050820(each), 20193489050827(case), Lot Number: 185212; 53) 60194273, UDI-DI: 10193489051094(each), 20193489051091(case), Lot Number: 133064; 54) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 181368; 55) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 187374; 56) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 176208; 57) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 181375; 58) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 185213; 59) 60210014, UDI-DI:… (truncated, 13411 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

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

Recall #:
98599
Lot/product code:
1) DYNJ07425, UDI-DI: 10080196866465(each), 40080196866466(case), Lot Number: 23DBP927; 2) DYNJ07425, UDI-DI: 10080196866465(each), 40080196866466(case), Lot Number: 23EBS362; 3) DYNJ38610I, UDI-DI: 10198459323102(each), 40198459323103(case), Lot Number: 25DBM593; 4) DYNJ38610I, UDI-DI: 10198459323102(each), 40198459323103(case), Lot Number: 25GBO740; 5) DYNJ45234A, UDI-DI: 10193489782554(each), 40193489782555(case), Lot Number: 23LBU617; 6) DYNJ45234A, UDI-DI: 10193489782554(each), 40193489782555(case), Lot Number: 23HBK865; 7) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24BMC721; 8) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24EMF715; 9) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24AMI140; 10) DYNJ63779A, UDI-DI: 10193489355840(each), 40193489355841(case), Lot Number: 25HBM008; 11) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 24HBF527; 12) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25BBL663; 13) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25CBN143; 14) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25EBJ520; 15) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25FBC657
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled February 24, 2026

Imu-Tek Colostrum-5 Powder; 30% IgG,1,000 mg 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band exterior seal, 24 ounces (680 grams) powder, 7 38654 00052 6, ImuTek Laboratories, Fort Collins, CO 80524.

Product is potentially under-processed.

AKALAZCACOCTFLHIIAIDILINMAMDMOMSNCNENHNVNYOKORSCTNTXUTWAWIWY
▸Full report

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

Recall #:
H-0661-2026
Lot/product code:
Lot #22, 020528 Expiration
Recalling firm:
Imu-Tek Animal Health, Incorporated
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled February 24, 2026

Imu-Tek Colostrum-5 120 Capsules; 30% IgG, 2 capsules 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band seal, 500 mg capsule, 7 38654 00026 7, Imu-Tek, Inc. Ft. Collins, CO 80524.

Product is potentially under-processed.

AKALAZCACOCTFLHIIAIDILINMAMDMOMSNCNENHNVNYOKORSCTNTXUTWAWIWY
▸Full report

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

Recall #:
H-0660-2026
Lot/product code:
Lot #013, 092826 Expiration
Recalling firm:
Imu-Tek Animal Health, Incorporated
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 24, 2026

Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.

Failed Dissolution Specifications

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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-0399-2026
Lot/product code:
Lot #: 3116110, 3116130, Exp. Date 07/2026
Recalling firm:
MYLAN PHARMACEUTICALS INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 23, 2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.

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

Recall #:
98498
Lot/product code:
Siemens Material Number (SMN): 11097536; UDI-DI: 00630414220505; Lot numbers: 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, 150621;
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 23, 2026

Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001

Surgical light assembly may not adequate support the weight of the ceiling cover.

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

Recall #:
98514
Lot/product code:
UDI: 07613327296167; All Lots
Recalling firm:
Stryker Communications
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 20, 2026

Radius VSM ECG pre-connected Set, REF: 4842, 4695

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.

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

Recall #:
98481
Lot/product code:
REF/UDI-DI/Lot: 4842/10843997011003/25AJH, 25KMA, 25MSC 4695/10843997016015/24N17, 25BBJ, 25DMH, 25FBR, 24KLV, 24N17, 25AGZ, 25BBJ, 25D10, 25DMH, 25FBR, 25GJM, 25KBF
Recalling firm:
Masimo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 20, 2026

Radius VSM Disposable NIBP Cuff, REF: 4825, 4826

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.

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▸Full report

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

Recall #:
98481
Lot/product code:
REF/UDI-DI/Lot: 4825/00843997006989/21G6S, 22JHV, 23H03, 23J05, 24DBV, 24NGG, 25ADG, E21D31, E21JWM, E23FVD; 4826/10843997006993/21HVX, 22ELB, 23G31, 23H04, 23HWL, 23J06, 24DBW, 24MNP, 24NGF, 25ADF, E21D32, E21F04, E21JFA, E21KHK
Recalling firm:
Masimo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 20, 2026

Brand Name: Elegance Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The EleganceAnterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Eleganceplates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance Anterior Cervical plate. Detailed information concerning the surgical technique of the EleganceAnterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.

Due to a quality issue regarding the presence of burr on the finished cervical plate product.

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

Recall #:
98442
Lot/product code:
Lot Code: See Excel sheet attached named "FDA 5072 Product Information" See Spreadsheet attached named "FDA 5072 Product Quantity Distributed" Catalog Number: 53430108 (ELEGANCE 1 LEVEL CERVICAL PLATE 8MM) UDI-DI code: 03700780644353 Lot Numbers: PC03X R879X Catalog Number: 53430110 (ELEGANCE 1 LEVEL CERVICAL PLATE 10MM) UDI-DI code: 03700780644353 Lot Numbers: P758X RAA2X R825X R902X Catalog Number: 53430111 (ELEGANCE 1 LEVEL CERVICAL PLATE 11MM) UDI-DI code: 03700780644384 Lot Numbers: R194X RAA1X Catalog Number: 53430112 (ELEGANCE 1 LEVEL CERVICAL PLATE 12MM) UDI-DI code: 03700780644391 Lot Numbers: R195X RAB2X Catalog Number: 53430113 (ELEGANCE 1 LEVEL CERVICAL PLATE 13MM) UDI-DI code: 03700780644407 Lot Numbers: R196X R197X R584X RA81X Catalog Number: 53430114 (ELEGANCE 1 LEVEL CERVICAL PLATE 14MM) UDI-DI code: 03700780644414 Lot Number: R585X Catalog Number: 53430116 (ELEGANCE 1 LEVEL CERVICAL PLATE 16MM) UDI-DI code: 03700780644438 Lot Number: R586X Catalog Number: 53430120 (ELEGANCE 1 LEVEL CERVICAL PLATE 20MM) UDI-DI code: 03700780644452 Lot Number: R182X Catalog Number: 53430220 (ELEGANCE 2 LEVEL CERVICAL PLATE 20MM) UDI-DI code: 03700780644452 Lot Numbers: R587X RAA0X Catalog Number: 53430224 (ELEGANCE 2 LEVEL CERVICAL PLATE 24MM) UDI-DI code: 03700780644490 Lot Number: R588X Catalog Number: 53430228 (ELEGANCE 2 LEVEL CERVICAL PLATE 28MM) UDI-DI code: 03700780644513 Lot Numbers: R589X RA80X Catalog Number: 53430230 (ELEGANCE 2 LEVEL CERVICAL PLATE 30MM) UDI-DI code: 03700780644520 Lot Numbers: R556X RA99X Catalog Number: 53430232 (ELEGANCE 2 LEVEL CERVICAL PLATE 32MM) UDI-DI code: 03700780644537 Lot Numbers: R590X RAB3X Catalog Number: 53430234 (ELEGANCE 2 LEVEL CERVICAL PLATE 34MM) UDI-DI code: 03700780644544 Lot Numbers: R591X R880X RA98X Catalog Number: 53430236 (ELEGANCE 2 LEVEL CERVICAL PLATE 36MM) UDI-DI code: 03700780644551 Lot Numbers: R592X R881X RA97X RAU3X Catalog Number: 53430240 (ELEGANCE 2 LEVEL CERVICAL PLATE 40MM) UDI-DI code: 03700780644575 Lot Numbers: R593X RA96X Catalog Number: 53430338 (ELEGANCE 3 LEVEL CERVICAL PLATE 38MM) UDI-DI code: 03700780644582 Lot Numbers: R5B7X RAV7X Catalog Number: 53430344 (ELEGANCE 3 LEVEL CERVICAL PLATE 44MM) UDI-DI code: 03700780644605 Lot Numbers: R5B2X RAY6X Catalog Number: 53430347 (ELEGANCE 3 LEVEL CERVICAL PLATE 47MM) UDI-DI code: 03700780644612 Lot Numbers: R5B3X R8H4X RA95X Catalog Number: 53430350 (ELEGANCE 3 LEVEL CERVICAL PLATE 50MM) UDI-DI code: 03700780644629 Lot Numbers: R579X RA94X Catalog Number: 53430353 (ELEGANCE 3 LEVEL CERVICAL PLATE 53MM) UDI-DI code: 03700780644636 Lot Number: R5B0X Catalog Number: 53430356 (ELEGANCE 3 LEVEL CERVICAL PLATE 56MM) UDI-DI code: 03700780644643 Lot Numbers: R5B1X R5B6X RB63X Catalog Number: 53430362 (ELEGANCE 3 LEVEL CERVICAL PLATE 62MM) UDI-DI code: 03700780644667 Lot Number: R594X
Recalling firm:
Clariance-SAS
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Class IIILow risk
DrugRecalled February 19, 2026

Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35

Failed Tablet/Capsule Specifications

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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-0401-2026
Lot/product code:
Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
Recalling firm:
Radnostix
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 19, 2026

Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No

Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.

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

Recall #:
98402
Lot/product code:
Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403
Recalling firm:
AMO Puerto Rico Manufacturing, Inc.
View official FDA record (opens in a new tab)