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Recalls affecting Hawaii

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

16,268 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

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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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/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IIModerate risk
DrugRecalled January 26, 2026

Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.

Presence of Foreign substance - potential presence of metal particulate matter

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-0326-2026
Lot/product code:
Lot#: 254000104, Exp. 05/27/2026
Recalling firm:
F.H. INVESTMENTS, Inc. (dba Asteria Health)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 26, 2026

Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

ALL 50 STATES
▸Full report

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

Recall #:
98326
Lot/product code:
System Model Numbers: (1)722068, (2)722226, (3)722236; UDI-DIs: (1)884838085367, (2)884838099272, (3)884838116801; Serial Numbers: All;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 26, 2026

Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

ALL 50 STATES
▸Full report

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

Recall #:
98326
Lot/product code:
System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); UDI-DIs: (1) 884838085282, (2) 884838099210, (3) 884838116733, (4)N/A; Serial Numbers: All;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 26, 2026

Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

ALL 50 STATES
▸Full report

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

Recall #:
98326
Lot/product code:
System Model Numbers: (1) 722063, (2) 722221, (3) 722229; UDI-DIs: (1) 884838085275, (2) 884838099203, (3) 884838116726; Serial Numbers: All;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 26, 2026

Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

ALL 50 STATES
▸Full report

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

Recall #:
98326
Lot/product code:
System Model Numbers: (1)722078, (2)722223, (3)722233; UDI-DIs: (1)884838085251, (2)884838099241, (3)884838116764; Serial Numbers: All;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 26, 2026

Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

ALL 50 STATES
▸Full report

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

Recall #:
98326
Lot/product code:
System Model Numbers:(1)722067, (2)722225, (3)722235; UDI-DIs:(1)884838085350, (2)884838099265, (3)884838116788; Serial Numbers: All;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 26, 2026

Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

ALL 50 STATES
▸Full report

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

Recall #:
98326
Lot/product code:
System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); UDI-DIs: (1)884838099234, (2)884838116757, (3)N/A; Serial Numbers: All;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 26, 2026

Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

ALL 50 STATES
▸Full report

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

Recall #:
98326
Lot/product code:
System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); UDI-DIs: (1)884838085268, (2)884838099258, (3)884838116771, (4)N/A; Serial Numbers: All;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 26, 2026

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

ALL 50 STATES
▸Full report

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

Recall #:
98326
Lot/product code:
System Model Numbers: (1)722227, (2)722231; UDI-DIs: (1)884838099227, (2)884838099258, (3)884838116740; Serial Numbers: All;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 26, 2026

ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.

Presence of Foreign substance - potential presence of metal particulate matter

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-0310-2026
Lot/product code:
Lot#: 253000118, Exp. 02/21/2026; 253000145, Exp. 08/02/2026; 253000146, Exp. 06/30/2026, 253000167, Exp. 09/23/2026.
Recalling firm:
F.H. INVESTMENTS, Inc. (dba Asteria Health)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 26, 2026

ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.

Presence of Foreign substance - potential presence of metal particulate matter

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-0309-2026
Lot/product code:
Lot#: 253000117, Exp. 02/21/2026; 253000129, Exp. 06/12/2026; 253000130, Exp. 06/16/2026; 253000154, 253000155, Exp. 08/29/2026; 253000160, Exp. 09/10/2026.
Recalling firm:
F.H. INVESTMENTS, Inc. (dba Asteria Health)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 26, 2026

Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.

Presence of Foreign substance - potential presence of metal particulate matter

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-0316-2026
Lot/product code:
Lot#: 251000143, Exp. 07/07/2026; 251000160, Exp. 08/16/2026.
Recalling firm:
F.H. INVESTMENTS, Inc. (dba Asteria Health)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 26, 2026

ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.

Presence of Foreign substance - potential presence of metal particulate matter

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-0311-2026
Lot/product code:
Lot#: 253000123, Exp. 06/02/2026.
Recalling firm:
F.H. INVESTMENTS, Inc. (dba Asteria Health)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 26, 2026

Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.

Presence of Foreign substance - potential presence of metal particulate matter

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-0317-2026
Lot/product code:
Lot#: 251000126, Exp. 06/03/2026.
Recalling firm:
F.H. INVESTMENTS, Inc. (dba Asteria Health)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 26, 2026

Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.

Presence of Foreign substance - potential presence of metal particulate matter

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-0327-2026
Lot/product code:
Lot#: 254000107, Exp. 06/30/2026; 254000111, Exp. 08/07/2026. .
Recalling firm:
F.H. INVESTMENTS, Inc. (dba Asteria Health)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 26, 2026

Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.

Presence of Particulate Matter: Due to production issues

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-0389-2026
Lot/product code:
Batch I012626R-01, Exp 02/09/2026
Recalling firm:
Radnostix
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 26, 2026

Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.

Presence of Foreign substance - potential presence of metal particulate matter

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-0318-2026
Lot/product code:
Lot#: 251000130, Exp. 06/02/2026; 251000137, 06/19/2026; 251000152, Exp. 08/02/2026; 251000168, Exp. 08/29/2026; 251000170, Exp. 09/03/2026
Recalling firm:
F.H. INVESTMENTS, Inc. (dba Asteria Health)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 26, 2026

Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.

Presence of Foreign substance - potential presence of metal particulate matter

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-0323-2026
Lot/product code:
Lot#: 251000132, Exp. 06/16/2026; 251000142, Exp. 06/30/2026; 251000144, Exp. 07/14/2026; 251000146, Exp. 07/21/2026; 251000162, 251000163, Exp. 08/16/2026; 251000167, Exp. 08/22/2026; 251000177, Exp. 09/12/2026.
Recalling firm:
F.H. INVESTMENTS, Inc. (dba Asteria Health)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 26, 2026

ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.

Presence of Foreign substance - potential presence of metal particulate matter

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-0314-2026
Lot/product code:
Lot#: 253000136, Exp. 07/01/2026.
Recalling firm:
F.H. INVESTMENTS, Inc. (dba Asteria Health)
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled January 26, 2026

Gerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 015000935726; Made for Gerber Products Co., Fremont, MI 49413

Downstream recall. Product contains arrowroot flour ingredient that was voluntarily recalled by the supplier due to potential contamination of soft kraft paper/plastic bag pieces.

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 #:
H-0518-2026
Lot/product code:
Product Number: 12212034 Batch Code/Best If Used By Date: - 5198565504 BB: 16 OCT 2026 - 5202565504 BB: 20 OCT 2026 - 5203565504 BB: 21 OCT 2026 - 5204565504 BB: 22 OCT 2026 - 5205565504 BB: 23 OCT 2026 - 5209565504 BB: 27 OCT 2026 - 5210565504 BB: 28 OCT 2026 - 5211565504 BB: 29 OCT 2026 - 5233565504 BB: 20 NOV 2026 - 5238565504 BB: 25 NOV 2026 - 5239565504 BB: 26 NOV 2026 - 5239565505 BB: 26 NOV 2026 - 5240565505 BB: 27 NOV 2026 - 5245565505 BB: 02 DEC 2026 - 5246565505 BB: 03 DEC 2026 - 5251565505 BB: 08 DEC 2026 - 5252565505 BB: 09 DEC 2026 - 5253565505 BB: 10 DEC 2026 - 5254565505 BB: 11 DEC 2026 - 5258565505 BB: 15 DEC 2026 - 5259565505 BB: 16 DEC 2026
Recalling firm:
Gerber Products Company dba Nestle Infant Nutrition
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 26, 2026

Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.

Presence of Foreign substance - potential presence of metal particulate matter

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-0324-2026
Lot/product code:
Lot#: 251000127, Exp. 06/03/2026; 251000128, Exp. 06/05/2026; 251000133, 251000134, 251000135, Exp. 06/16/2026; 251000138, 251000139, 251000140, 251000141, Exp. 06/25/2026; 251000147, 251000148, 251000149, Exp. 07/28/2026; 251000156, 251000157, Exp. 08/08/2026; 251000164, 251000165, 251000166, Exp. 08/22/2026; 251000169, Exp. 08/29/2026; 251000171, 251000172, Exp. 09/03/2026; 251000180, Exp. 09/19/2026.
Recalling firm:
F.H. INVESTMENTS, Inc. (dba Asteria Health)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

ALL 50 STATES
▸Full report

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

Recall #:
98341
Lot/product code:
1. Article Number (Lot Numbers): 21311-11 (26/F62573), 21311-15 (26/F65048, 26/F67521), 21311-7 (26/F66165, 26/F67825), 21312-11 (26/F65049, 26/F67826), 21312-15 (26/F66166), 21312-7 (26/F65643, 26/F67827). 2. Article Number (Lot Numbers): 21094-10 (643/032304, 643/082309), 21094-4 (643/0572, 643/0571), 21094-6 (643/112202), 21094-8 (643/012309). 3.Article Number (Lot Numbers): 21093-4 (679/032311, 679/112331), 21093-6 (679/112332).
Recalling firm:
I.T.S. GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-Column Plate; Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12. 4. Cancellous Screw; Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90. 5. Cancellous Screw, Locking; Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37422-30-N, 37422-32-N, 37422-34-N, 37422-36-N, 37422-38-N, 37422-40-N, 37422-42-N, 37422-44-N, 37422-46-N, 37422-48-N, 37422-50-N, 37422-55-N, 37422-60-N, 37422-65-N, 37422-70-N, 37422-75-N, 37422-80-N, 37422-85-N, 37422-90-N, 37422-95-N, 37422-100-N, 37422-105-N, 37422-110-N, 37422-115-N, 37422-120-N, 37592-18, 37592-20, 37592-22, 37592-24, 37592-26, 37592-28, 37592-30, 37592-32, 37592-34, 37592-36, 37592-38, 37592-40, 37592-42, 37592-46, 37592-48, 37592-50, 37592-54, 37592-56, 37592-58, 37592-60, 37592-65, 37592-70, 37592-75, 37592-80, 37592-85, 37592-90. 6. Cannulated Screw, Cancellous; Article Numbers: 31851-60, 31851-65, 31851-70, 31851-75, 31851-80, 31851-85, 31851-90, 31851-95, 31851-100, 31851-105, 31851-110, 31851-115, 31851-120, 31851-125, 31851-130, 31851-135, 31851-140, 31851-145, 31851-150, 31851-155, 31851-160, 31851-165, 31851-170, 31851-175, 31851-180, 31851-185, 31851-190, 31851-195, 31851-200, 31854-60, 31854-65, 31854-70, 31854-75, 31854-80, 31854-85, 31854-90, 31854-95, 31854-100, 31854-105, 31854-110, 31854-115, 31854-120, 31854-125, 31854-130, 31854-135, 31854-140, 31854-145, 31854-150, 31854-155, 31854-160, 31854-165, 31854-170, 31854-175, 31854-180, 31854-185, 31854-190, 31854-195, 31854-200. 7. Cortical Screw; Article Numbers: 32351-10, 32351-12, 32351-14, 32351-16, 32351-18, 32351-20, 32351-22, 32351-24, 32351-26, 32351-28, 32351-30, 32351-32, 32351-34, 32351-36, 32351-38, 32351-40, 32351-42, 32351-44, 32351-46, 32351-48, 32351-50, 32351-55, 32351-60, 32351-65, 32351-70, 32351-75, 32351-80, 32351-85, 32352-16, 32352-18, 32352-20, 32352-22, 32352-24, 32352-26, 32352-28, 32352-30, 32352-32, 32352-34, 32352-36, 32352-38, 32352-40, 32352-42, 32352-44, 32352-46, 32352-48, 32352-50, 32352-55, 32352-60, 32352-65, 32352-70, 32352-75, 32352-80, 32352-85, 32352-90, 32352-95, 32352-100, 32352-105, 32352-110, 32352-115, 32352-120, 32455-18, 32455-20, 32455-22, 32455-24, 32455-26, 32455-28, 32455-30, 32455-32, 32455-34, 32455-36, 32455-38, 32455-40, 32455-42, 32455-44, 32455-46, 32455-48, 32455-50, 32455-52, 32455-54, 32455-56, 32455-58, 32455-60, 32455-65, 32455-70, 32455-75, 32455-80, 32455-85, 32455-90, 32475-32. 8. Cortical Screw, Locking; Article Numbers: 37455-18, 37455-20, 37455-22, 37455-24, 37455-26, 37455-28, 37455-30, 37455-32, 37455-34, 37455-36, 37455-38, 37455-40, 37455-42, 37455-44, 37455-46, 37455-48, 37455-50, 37455-52, 37455-54, 37455-56, 37455-60, 37455-65, 37455-70, 37455-75, 37455-80, 37455-85, 37455-90. 9. Curved Plate; Article Numbers: 211911-4, 211911-5, 211911-6, 211911-7, 211911-8, 211911-10, 211911-12, 211911-14, 211911-16, 211911-20. 10. Posterior Column Plate, Left; Article Numbers: 212121-6. 11. Posterior Column Plate, Right; Article Numbers: 212131-6. 12. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-SM. 13. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-LA. 14. Posterior Wall Plate, Extended, Right; Article Numbers: 212111-LA, 212111-SM. 15. Posterior Wall Plate, Left; Article Numbers: 212141-7, 212141-8. 16. Posterior Wall Plate, Right; Article Numbers: 212151-7, 212151-8. 17. PRS Plate; Article Numbers: 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7. 18. Quadrilateral Buttress Plate; Article Numbers: 21208-13, 21209-13. 19. Quadrilateral Buttress Plate; Article Numbers: 21208-11, 21209-11. 20. Rim Plate, Left; Article

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

ALL 50 STATES
▸Full report

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

Recall #:
98341
Lot/product code:
1. Article Number (Lot Numbers): 21218-16 (679/112166, 679/122229, 679/122230, 679/122304), 21219-16 (679/012441, 679/062456, 679/0624561, 679/112167, 679/122228). 2. Article Number (Lot Numbers): 21218-14(679/032417, 679/102231, 679/112158, 679/112164, 679/122231), 21219-14 (679/012505, 679/112159, 679/112165, 679/122227, 679/122305). 3. Article Number (Lot Numbers): 21216-10 (679/032501, 679/062453, 679/072276, 679/072510, 679/092203, 679/092401, 679/112168, 679/112409, 679/122270), 21216-12 (679/032503, 679/062344, 679/062454, 679/072277, 679/092204, 679/112170, 679/112413, 679/122271), 21217-10 (679/032502, 679/062346, 679/072278, 679/092402, 679/092404, 679/102216, 679/112169, 679/112423), 21217-12 (679/022238, 679/062345, 679/072513, 679/092403, 679/112171, 679/122407, 679/122426). 4. Article Number (Lot Numbers): 30591-36 (18/922090), 30591-70 (18/231539, 18/775273), 30591-75 (18/751307), 30591-80 (18/777295), 30591-85 (18/301308), 30591-90 (18/311309). 5. Article Number (Lot Numbers): 37422-12-N (18/145897, 18/461842), 37422-14-N (18/215281, 679/032001, 679/062320, 679/092355, 679/122326), 37422-16-N (679/052229, 679/052307, 679/102214, 679/102306, 679/122329), 37422-18-N (18/240520, 18/452529, 18/473354, 679/052316, 679/102215, 679/102337, 679/122330), 37422-20-N (679/0323147, 679/072306, 679/102211, 679/102338, 679/122331), 37422-22-N (18/092876, 18/543636, 679/012406, 679/062361, 679/072312, 679/102212, 679/102348), 37422-24-N (679/012407, 679/052333, 679/072313, 679/102349), 37422-26-N (679/012435, 679/062316, 679/072322, 679/102353), 37422-28-N (18/192499, 679/012422, 679/032211, 679/062317, 679/062323, 679/072323, 679/102361), 37422-30-N (18/217289, 679/012436, 679/032212, 679/0323142, 679/072324, 679/102354), 37422-32-N (18/218290, 679/012437, 679/052335, 679/052337, 679/072329, 679/112306), 37422-34-N (18/031830, 18/219291, 679/012446, 679/062337, 679/062341, 679/072330, 679/112318), 37422-36-N (18/220292, 18/240540, 18/734742, 679/012447, 679/042317, 679/042321, 679/062003, 679/072334, 679/102361), 37422-38-N (18/105881, 18/221293, 18/362296, 18/412482, 679/012243, 679/022407, 679/052331, 679/052334, 679/072349, 679/112323), 37422-40-N (18/052830, 18/222294, 18/240538, 18/493069, 18/736744, 679/022401, 679/032310, 679/042302, 679/072354, 679/112329), 37422-42-N (18/053831, 18/081544, 18/223295, 18/364298, 18/733745, 679/022402, 679/062371, 679/082304, 679/112330), 37422-44-N (18/054832, 18/224296, 18/365299, 18/737746, 18/781832, 679/022412, 679/042331, 679/042345, 679/082314, 679/112335), 37422-46-N (18/052578, 18/225314, 18/366300, 18/738747, 679/022419, 679/042313, 679/042318, 679/082319, 679/112336), 37422-48-N (18/056834, 18/226315, 679/022423, 679/052324, 679/052328, 679/072316, 679/092314, 679/112337), 37422-50-N (18/227316, 18/740748, 679/022436, 679/042336, 679/052314, 679/092342, 679/112338), 37422-55-N (18/113882, 18/368302, 679/032215, 679/052336, 679/062309, 679/092322, 679/112324), 37422-60-N (18/229318, 18/240517, 18/927095, 28/33034, 679/032403, 679/062349, 679/062351, 679/092325, 679/122307), 37422-65-N (18/118884, 18/230319, 18/271754, 18/743749, 18/761192, 28/35846, 679/032216, 679/072303, 679/092326, 679/122308), 37422-70-N (679/102213, 18/744750, 18/893916, 679/062368, 679/092338, 679/102213, 679/122309), 37422-75-N (18/122888, 18/231839, 679/072304, 679/122306), 37422-80-N (679/122254, 18/124887, 679/062352, 679/122320), 37422-85-N (18/056936, 18/271837, 679/012256, 679/092339), 37422-90-N (18/050600, 18/321273, 679/092340), 37422-95-N (18/130891, 679/092341), 37422-100-N (18/132892, 18/341607, 679/102403), 37422-105-N (679/102404), 37422-110-N (18/136894, 18/371843, 679/092337), 37422-115-N (18/138895, 18/391845, 679/012262), 37422-120-N (18/140896, 679/092349), 37592-18 (679/072351), 37592-20 (18/831792, 18/252862), 37592-22 (18/172773, 679/072356), 37592-24 (679/082301), 37592-26 (18/182774, 679/082303), 37592-28 (679/012140, 679/082310), 37592-30 (18/112775, 679/082317), 37592-32 (679/082312), 37592-34 (18/192863, 679/082313), 37592-36 (679/082318), 37592-38 (679/092308), 37592-40 (679/052116, 679/072314), 37592-42 (679/092310), 37592-46 (18/092772, 679/092312), 37592-48 (679/052118, 679/092313), 37592-50 (679/092343), 37592-54 (679/072315), 37592-56 (18/721587), 37592-58 (679/092334), 37592-60 (679/042213, 679/072325, 679/092345), 37592-65 (679/072331), 37592-70 (679/042289, 679/072340, 679/092353), 37592-75 (18/429442, 679/092351), 37592-80 (679/052204, 679/072341, 679/092335), 37592-85 (679/042291, 679/072342, 679/092354), 37592-90 (679/042292, 679/092352). 6. Article Number (Lot Numbers): 31851-60 (18/373463, 18/813133), 31851-65 (18/374464), 31851-70 (18/375465), 31851-75 (18/376467), 31851-80 (18/125212, 18/377468, 18/431563, 18/867967), 31851-85 (18/044945, 18/378469, 18/441564), 31851-90 (18/045946, 18/343266, 18/451565), 31851-95 (18/046947, 18/128224, 18/379470, 18/461566), 31851-100 (18/129225, 18/471567, 18/821469, 18/860968), 31851-105 (18/38… (truncated, 17533 characters total — see the official FDA record for the full value)
Recalling firm:
I.T.S. GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

ALL 50 STATES
▸Full report

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

Recall #:
98341
Lot/product code:
1 Article number (Lot Numbers): 21112-7 (643/0549), 21114-5 (643/032301, 643/042303, 643/042304, 643/0618, 643/102211, 643/112304), 21113-9 (643/072320). 2. Article number (Lot Numbers): 21111-6 (643/032306, 643/072319, 643/112201), 21111-8 (643/032318), 21111-12 (643/032305).
Recalling firm:
I.T.S. GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

ALL 50 STATES
▸Full report

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

Recall #:
98341
Lot/product code:
1. Article Number (Lot Numbers): 31404-16 (679/062339, 679/122213, 679/122332), 31404-18 (679/122212, 679/062340), 31404-20 (18/089221, 679/062343, 679/122241), 31404-22 (18/061535, 679/012416, 679/062350), 31404-24 (18/071536, 679/062362, 679/122246), 31404-26 (679/122245, 679/062363), 31404-28 (18/186278, 679/062364), 31404-30 (18/187299, 679/012401, 679/062365, 679/122242), 31404-32 (18/111540, 679/062366, 679/122211), 31404-34 (679/122206, 18/121544, 679/012402, 679/042414, 679/072302, 679/122206), 31404-36 (18/188300, 679/052403, 679/072305, 679/112223), 31404-38 (18/189301, 679/112213, 679/012455, 679/072309), 31404-40 (18/181043, 679/062321, 679/122201, 679/122310, 679/052404, 679/032532), 31404-42 (679/122203, 18/191303, 679/072310, 679/012418, 679/052424, 679/052505), 31404-44 (18/192304, 679/112232, 679/052332, 679/052425, 679/052508), 31404-46 (679/122240, 679/062322, 679/112210, 679/052426, 679/042505), 31404-48 (679/052427, 679/072317, 679/122248), 31404-50 (18/194306, 679/112228, 679/062301, 679/122311, 679/052406, 679/052413, 679/042506, 679/062501), 31404-55 (18/195307, 679/122258, 18/211647, 679/072326, 679/012452, 679/062467, 679/062511), 31404-60 (18/196308, 679/112240, 679/052325, 679/122312, 679/062485, 679/062512), 31404-65 (679/122259, 679/072327, 18/205310, 679/022410), 31404-70 (679/012301, 18/197309, 679/072328, 679/022413, 679/062479), 31404-75 (18/205411, 18/381989, 679/012302), 31404-80 (18/172638, 18/205232, 18/321164, 679/022416), 31457-30 (26/F50332), 31457-36 (18/198343), 31457-40 (18/199344), 31457-46 (18/947783, 18/736681), 31457-50 (18/201346, 26/F67796), 31457-55 (18/202347, 26/F67797), 31457-60 (18/203355), 31652-100 (679/122117, 679/022350, 679/102335, 679/022335, 18/924999), 31652-105 (679/022336, 679/032377), 31652-110 (679/032380, 679/102339), 31652-115 (679/102336), 31652-120 (679/092002, 679/102347), 31652-25 (679/112134, 679/032340), 31652-30 (679/032341), 31652-35 (679/082315), 31652-40 (679/082316), 31652-45 (679/032330, 679/092332), 31652-55 (679/032391, 679/092333), 31652-60 (679/022337, 679/032378, 679/092336), 31652-65 (679/022338, 679/032322, 679/092347), 31652-70 (679/032320, 679/032365, 679/042405, 679/112154), 31652-75 (26/F65330, 679/032348, 679/032386), 31652-80 (679/112181, 679/032321, 679/092350, 679/032362, 679/092348, 679/042410, 18/920995), 31652-85 (679/122145, 679/032382, 679/022349, 679/102301, 679/102305, 679/042411, 18/541045), 31652-90 (679/012201, 679/032383, 679/032383, 679/022347, 679/042406), 31652-95 (18/923998, 679/012202, 679/032316), 31731-100 (18/775943, 26/F58803, 679/102420), 31731-105 (18/776944, 26/F58804, 26/F65649, 679/102421), 31731-110 (26/F58805, 26/F65650, 679/102422), 31731-115 (26/F58806, 26/F65651, 679/102423), 31731-120 (26/F58807, 26/F65652, 679/102436), 31731-50 (09/1244, 26/F14488, 26/F21185, 26/F58793), 31731-60 (26/F58795, 26/F65655), 31731-65 (26/F65656, 26/F58796), 31731-70 (26/F58797, 26/F65657), 31731-75 (26/F58798, 26/F65658), 31731-80 (679/072040, 26/F58799, 26/F65659), 31731-85 (18/331317, 26/F65660, 679/072044), 31731-90 (09/1247, 09/1248, 26/F58801, 26/F65661, 46/612), 31731-95 (18/581247, 26/F58802, 26/F65662, 679/102437), 31732-60 (18/961265), 31734-100 (26/F65672), 31734-105 (26/F58839, 26/F65673), 31734-110 (26/F58840, 26/F65674, 679/032425), 31734-115 (26/F65675), 31734-120 (26/F58842, 26/F65676, 26/F72277), 31734-45 (18/761192), 31734-50 (26/F58828, 26/F65680), 31734-60 (26/F58830), 31734-65 (26/F58831, 26/F65683, 679/032428), 31734-70 (26/F58832, 26/F65684, 26/F72275, 679/032429), 31734-75 (26/F58833, 26/F65685), 31734-80 (26/F58834, 26/F65686, 679/032435), 31734-85 (26/F58835, 26/F65687, 26/F72276), 31734-90 (26/F65688, 679/032436), 31734-95 (26/F58837, 26/F65689, 679/042401). 2. Article Number (Lot Numbers): 31277-18 (26/F36049), 31357-20 (18/091247), 31357-22 (679/031707), 31357-24 (86/485378), 31357-26 (18/121250), 31357-28 (26/F65909), 31357-30 (18/165201, 18/341054), 31357-32 (18/166217), 31357-34 (18/167218), 31357-36 (18/168219, 26/F65910), 31357-38 (18/167220), 31357-40 (26/F65911, 18/170221), 31357-42 (26/F65912), 31357-44 (18/171222, 18/361059, 26/F65913), 31357-46 (18/861060), 31357-48 (18/172223, 26/F65914), 31357-60 (26/F65648), 31357-65 (679/012125), 31357-70 (18/902013). 3. Article Number (Lot Numbers): 36851 (26/F59918, 26/F61351, 26/F64885, 26/F64886, 26/F65908, 26/F66506, 26/F71413, 26/F71764, 26/F72364, 26/F73020, 26/F74288). 4. Article Number (Lot Numbers): 36432 (26/F65379, 26/F67799, 26/F72744, 774/300002), 36653 (26/F62590, 26/F68455), 36732 (26/F67800). 5. Article Number (Lot Numbers): 36431 (26/F62589, 26/F65378, 26/F66505, 26/F67798, 26/F70092, 26/F72743, 26/F73017, 26/F73494), 36651 (26/F61694, 26/F65380, 26/F68454, 26/F73018), 36653 (26/F73019), 36731 (26/F60987, 26/F62591, 26/F67523, 26/F70093, 26/F72363, 26/F73495).
Recalling firm:
I.T.S. GmbH
View official FDA record (opens in a new tab)