BIGNOPE
Ko-fi

Recalls affecting Delaware

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

16,320 recalls found
NewOld
High RiskLow Risk
AllClear

Just announced

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

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

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

▸Full report
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
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 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)
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 23, 2026

I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.

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): 21301-5 (26/F62569), 21301-7 (26/F62570), 21301-9 (26/F67518), 21301-13 (26/F62568, 26/F67815), 21302-5 (26/F67520), 21302-7 (26/F67821), 21302-9 (26/F62572, 26/F67822), 21302-13 (26/F62571, 26/F67519, 26/F67820). 2. Article Number (Lot Numbers): 21321-7 (26/F54955, 26/F62576), 21321-12 (26/F55883), 21322-7 (26/F55890, 26/F62578), 21322-12 (26/F62577). 3. Article Number (Lot Numbers): 21325-4 (26/F70528, 679/022433, 679/032217, 679/102240, 679/102242, 679/102303), 21325-7 (679/102241, 679/102304).
Recalling firm:
I.T.S. GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

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 Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736).
Recalling firm:
I.T.S. GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

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:
Article Number (Lot Numbers): 21064-60 (679/012318, 679/0722100).
Recalling firm:
I.T.S. GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.

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): 32151-6 (18/408462, 18/500495, 18/691266), 32151-8 (18/408866, 18/531370), 32151-9 (18/351668, 18/541373, 18/741269), 32151-10 (18/408986, 18/551374), 32151-11 (18/371670, 18/561375), 32151-12 (18/409087, 18/571376, 18/771272), 32151-13 (18/581377), 32151-14 (18/409289, 18/591378, 18/791274), 32151-15 (18/409390), 32151-16 (18/409491), 32151-18 (18/821277), 32151-20 (18/831278). 2. Article Number (Lot Numbers): 21505-4 (86/350493, 86/677353), 21506-4 (86/642718, 86/677157). 3. Article Number (Lot Numbers): 21507-4 (26/F65050), 21508-4 (26/F63934, 86/677180). 4. Article Number (Lot Numbers): 21517 (26/F66911). 5. Article Number (Lot Numbers): 21502 (86/677136), 21503-4 (86/337934), 21503-6 (86/868870), 21503-8 (26/F63936), 21503-10 (86/337896, 86/677146), 21504-6 (26/F63364, 86/868885), 21504-8 (26/F63365), 21504-10 (86/642711, 86/677154). 6. Article Number (Lot Numbers): 21513-3 (86/677385), 21513-5 (86/677389), 21514-3 (26/F63935), 21514-5 (86/642722, 86/677183, 86/869183). 7. Article Number (Lot Numbers): 37151-5 (18/561228), 37151-8 (18/166019), 37151-9 (18/625633), 37151-10 (18/626634), 37151-12 (18/628636, 18/671232), 37151-13 (18/166423), 37151-15 (18/206189), 37151-16 (18/132035, 18/691234), 37151-18 (18/142036), 37151-24 (18/167068, 18/172039), 37251-8 (18/421197), 37251-9 (18/591223), 37251-11 (18/619644), 37251-12 (18/620645, 18/962052), 37251-13 (18/521703), 37251-14 (18/531704, 18/951141), 37251-16 (18/002056, 18/031952, 18/623648, 18/971143), 37251-20 (18/571708, 26/F61731).
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. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.

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): 21602-3 (643/072330, 643/092310), 21602-4 (643/072301, 643/072308), 21602-5 (643/022417, 643/0650, 643/072309), 21602-6 (643/042305, 643/072333), 21602-7 (643/072332, 643/082305), 21602-8 (43/0405, 643/012305), 21603-3 (643/072331, 643/082306), 21603-4 (643/102214, 643/102206, 643/072302, 643/022313, 643/032310), 21603-5 (643/072335, 643/122308), 21603-6 (643/022309, 643/072305, 643/072311, 643/122309), 21603-7 (643/072337, 643/082313), 21603-8 (643/072312, 643/122204). 2. Article Number (Lot Numbers): 21225-4 (768/20894, 26/F65041, 26/F66149, 679/092305, 679/022430, 26/F705141, 26/F72362, 26/F73634), 21225-6 (768/20895, 768/20039, 26/F65042, 26/F66150, 26/F66499, 679/092321, 26/F705161, 679/062459, 26/F70516, 26/F73635), 21225-8 (768/20896, 26/F65635, 26/F66500, 26/F70515), 21225-10 (26/F66497), 21225-12 (26/F66498, 679/012438), 21226-4 (26/F65043, 26/F66152, 26/F66501, 26/F70521, 26/F705211, 679/012412, 679/062306, 679/092306, 768/20897, 768/208978), 21226-6 (26/F35433, 26/F65044, 26/F66502, 26/F70522, 26/F705221, 679/062307, 679/092307, 768/20898), 21226-8 (26/F66503, 679/012413, 768/20045, 768/20899), 21226-10 (26/F66151), 21226-12 (26/F66148, 679/012411). 3. Article Number (Lot Numbers): 21601-5 (643/012302, 643/072323), 21601-6 (643/072326, 770/201904), 21601-7 (643/012303, 643/022308, 643/0647, 643/072315, 643/072327, 643/082303), 21601-8 (643/072328, 643/072329), 21601-10 (643/022312, 643/082301, 643/082302), 21601-12 (26/F70342), 21601-14 (26/F70343), 21601-16 (26/F70344).
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. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

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): 21604-6 (643/052301, 643/0652, 643/092201), 21604-9 (643/032311, 643/062308, 643/062309, 643/112310, 643/122201). 2. Article Number (Lot Numbers): 21605-11 (643/072314, 643/102207), 21605-6 (643/0654, 643/072306, 643/072316, 643/072338, 643/102208, 643/102212, 643/102217, 643/112306, 643/122202), 21605-9 (643/0643, 643/0662, 643/072307, 643/072339, 643/112309, 643/122203). 3. Article Number (Lot Numbers): 21105-6 (86/876787), 21105-8 (86/876788). 4. Article Number (Lot Numbers): 21104-4 (679/052234, 679/082305, 86/036334), 21104-5 (679/0722101, 679/082306, 86/036335), 21104-6 (679/012307, 86/876760), 21104-7 (679/082307, 86/036336, 86/876781), 21104-8 (679/082308, 86/876783), 21104-9 (86/876904). 5. Article Number (Lot Numbers): 21101-5 (86/876637), 21101-6 (679/121605, 00/1105-12, 26/F41923, 86/876638, 86/903610), 21101-7 (770/201905, 00/0518-06, 679/042303, 86/876640), 21101-8 (86/876721, 679/062224), 21101-9 (679/122264, 86/876727), 21101-11 (86/876633), 21101-13 (86/876635). 6. Article Number (Lot Numbers): 21102-6 (770/201905). 7. Article Number (Lot Numbers): 21103-8 (679/092216), 21103-9 (679/062215, 86/876758), 21103-10 (679/092219, 86/876741), 21103-11 (679/062214), 21103-12 (86/876743), 21103-13 (679/022303, 86/876745).
Recalling firm:
I.T.S. GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.

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): 21116-8 (679/092230), 21117-10 (679/032313, 679/092231), 21118-10 (679/032314, 679/072047, 679/092232). 2. Article Number (Lot Numbers): 21121-6 (679/092236, 679/092329), 21121-8 (679/052226). 3. Article Number (Lot Numbers): 21122-10 (00/0425-02, 00/0825-02, 679/022443, 679/062310, 86/043372), 21122-6 (00/0325-01, 00/0425-01, 679/042340, 679/062334, 679/122269, 86/043366), 21122-8 (00/0325-08, 679/022243, 679/022304, 679/022451, 679/042209, 679/042214, 679/052319, 679/102368, 86/043368). 4. Article Number (Lot Numbers): 21123-4 (00/0810-06, 679/052014, 679/062216), 21124-4 (679/042333, 679/062217, 679/072346), 21127-6 (679/052228), 21128-6 (679/042341).
Recalling firm:
I.T.S. GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

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:
Article Number (Lot Numbers): 31207-10 (679/112002), 31207-12 (679/092133, 679/102343, 679/112006), 31207-14 (679/102050), 31207-16 (679/102345, 679/102049), 31207-18 (679/0323110, 679/102355, 679/112001), 31207-20 (679/0323111, 679/102051, 679/102356), 31207-24 (679/102028), 31207-26 (679/112008), 31207-28 (679/112009), 31207-30 (679/0323140, 86/483377), 31257-12 (679/081904), 31257-14 (679/042323, 679/081905), 31257-16 (679/042324), 31257-18 (679/112308, 679/022128), 31257-20 (679/022123, 679/042326, 679/112321), 31257-22 (679/022124, 679/042327, 679/112325), 31257-24 (679/022125, 679/112326), 31257-28 (679/022130, 679/052306), 31257-30 (679/022131), 31307-18 (679/061907), 31307-32 (679/062285), 31307-34 (679/062286), 31307-36 (679/062287), 31307-38 (679/032118), 31358-30 (26/F67790), 31437-30 (679/071916), 31437-38 (679/071918), 31437-40 (679/032406, 679/071903), 31437-50 (679/071920), 31757-100 (35/51892), 31757-120 (86/320792), 31757-45 (86/320793), 31757-80 (26/F55872), 31757-85 (26/F55873), 31757-90 (26/F55874).
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: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.

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:
Article Number (Lot Numbers): 211341-10 (26/F63368, 26/F65625, 26/F66904, 26/F669041, 679/012410), 211341-4 (26/F63366, 26/F65626, 26/F656261, 26/F66145, 26/F661451, 26/F66496, 26/F66905, 26/F669051, 26/F73497, 679/012439, 679/022450), 211341-7 (26/F63367, 26/F65627, 26/F66146, 26/F66906, 679/012440), 21134-4 (768/18758, 768/19642), 21134-5 (778/201904), 21135-4 (26/F67801, 768/21382), 21136-4 (26/F65629, 26/F66907, 26/F67802, 26/F70071, 768/21383), 21136-5 (770/101901), 21136-7 (26/F65039, 26/F65630), 21137-4 (26/F65631, 26/F67804, 768/21384), 21137-7 (26/F65040), 21138-4 (26/F65633, 26/F66908, 26/F67806), 21139-4 (26/F65634, 26/F67807, 768/21386).
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)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

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): 37303-10 (18/151720, 18/268729, 679/032432, 679/072268, 679/102237, 679/102307), 37303-12 (18/570637, 679/032434, 679/072269, 679/102346, 679/112227), 37303-14 (18/751091, 26/F66913, 679/012510, 679/062288, 679/102359, 679/112410), 37303-16 (679/072263, 679/102245, 18/151841, 26/F66914, 18/331193, 18/543625, 679/012511, 679/042403, 679/102360), 37303-18 (18/151942, 18/210467, 18/231415, 18/341194, 18/572633, 18/771093, 679/012512, 679/022507, 679/042404, 679/102248, 679/112319), 37303-20 (18/152043, 18/211468, 18/351195, 18/573634, 18/701585, 18/781094, 679/022508, 679/042420, 679/112216, 679/112328), 37303-22 (18/171705, 18/212469, 18/361196, 18/574635, 18/791095, 679/022509, 679/042417, 679/112224, 679/112340), 37303-24 (18/575639, 18/741572, 26/F66915, 679/022510, 679/112226, 679/122313, 679/122333), 37303-26 (18/152346, 18/214471, 26/F66916, 679/012403, 679/112230, 679/122323), 37303-28 (26/F66917, 679/112231, 679/122328), 37303-30 (18/192716, 18/591743, 679/122334). 2. Article Number (Lot Numbers): 32271-10 (18/061949, 18/231167, 679/062351), 32271-12 (18/048927, 26/F66235, 679/042215, 679/062342, 679/062405, 679/062489, 679/072271), 32271-14 (18/049928, 18/231165, 26/F66140, 679/042210, 679/052340, 679/052518, 679/062471, 679/062490, 679/072267), 32271-16 (18/231164, 18/311125, 26/F66141, 679/042216, 679/052519, 679/062315, 679/062483, 679/072272, 679/072401), 32271-18 (18/062950, 26/F65556, 26/F66236, 679/032261, 679/062332, 679/072402), 32271-20 (18/063951, 26/F66237, 679/052326), 32271-22 (18/064952, 26/F65557, 679/032263, 679/062354), 32271-24 (18/065953, 26/F65558, 679/062333), 32271-26 (679/032265), 32271-28 (26/F65559, 679/062357, 679/052520), 32271-32 (26/F65561), 32271-34 (26/F65562). 3. Article Number (Lot Numbers): 37304-10 (18/635486, 26/F24799, 679/012419, 86/011176), 37304-12 (18/061352, 18/521172, 18/5211721, 18/576643, 18/630487, 679/012433, 679/092207, 679/122409), 37304-14 (18/081360, 18/531173, 18/5311731, 18/577644, 18/631488, 679/012434, 679/092208, 679/122410), 37304-16 (18/541174, 18/578645, 18/632489, 679/012444, 679/092201, 679/122411), 37304-18 (18/092020, 18/551175, 18/633490, 679/022403, 679/092202), 37304-20 (18/011320, 18/561176, 18/634491, 679/012287, 679/012420, 679/082217, 86/483331), 37304-22 (18/241273, 679/012288, 679/012421), 37304-24 (18/021321, 18/571177, 679/012289, 679/012445). 4. Article Number (Lot Numbers): 21413-6 (26/F52124). 5. Article Number (Lot Numbers): 21431-ME (679/102045). 6. Article Number (Lot Numbers): 21482 (679/092020), 21483 (26/F55902). 7. Article Number (Lot Numbers): 21421-5 (26/F65377, 679/092039). 8. Article Number (Lot Numbers): 37241-10 (18/012169, 18/610104, 18/701013), 37241-12 (18/231295, 18/767108), 37241-14 (18/511016, 18/537392, 26/F24807, 679/012280), 37241-16 (18/005340, 18/121106, 18/231387, 18/521017, 18/560517), 37241-18 (18/232328, 18/531018, 679/072408, 86/311848), 37241-20 (18/233388, 18/541020, 18/562519, 679/072419, 86/287847), 37241-22 (18/066109, 18/234389, 18/551021, 26/F24594, 26/F24811), 37241-24 (18/561022, 18/564521, 18/608110, 26/F24595), 37241-26 (18/611111, 18/711023, 26/F24596, 26/F24813), 37241-28 (18/612112, 18/721024, 18/811597, 26/F24597, 86/485508), 37241-30 (18/015172, 18/613113, 18/731019, 26/F24598). 9. Article Number (Lot Numbers): 21015-08 (00/0123-12, 00/0321-43, 00/0723-07), 21015-09 (00/0123-13).
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. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.

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): 21232-3 (26/F65636), 21232-4 (26/F61722, 26/F65637), 21232-6 (26/F62564, 26/F65638), 21233-3 (26/F65639), 21233-4 (26/F65640), 21233-6 (26/F61723, 26/F65046), 21234-4 (26/F65641, 26/F66504), 21235-4 (26/F65642, 26/F67810). 2. Article Number (Lot Numbers): 21231-6 (643/012301, 643/022310, 643/032308, 643/0630, 643/0657, 643/102402, 643/122301). 3. Article Number (Lot Numbers): 37302-18 (18/636447), 37302-20 (18/802189).
Recalling firm:
I.T.S. GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.

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): 37351-10-N (18/240314, 679/122205), 37351-12-N (18/200330, 18/943977, 26/F65544, 679/032401, 679/052417, 679/122261), 37351-14-N (18/201331, 18/511504, 18/944978, 26/F65545, 679/032402, 679/032514, 679/052244, 679/052418, 679/052516, 679/072520), 37351-16-N (18/202332, 18/521505, 18/945979, 26/F65163, 679/032423, 679/032504, 679/052201, 679/062466, 679/062504, 679/072521, 679/122251), 37351-18-N (18/203333, 18/531506, 18/946980, 18/971215, 26/F65546, 679/022329, 679/022516, 679/032430, 679/062206, 679/062505, 679/072522), 37351-20-N (18/231334, 18/541507, 18/952981, 26/F65164, 26/F65547, 679/032431, 679/062230, 679/072501, 679/122202), 37351-22-N (18/233335, 18/953982, 26/F65548, 679/062233, 679/092111, 679/122210), 37351-24-N (18/238336, 18/956983, 26/F65549, 679/042415, 679/072203, 679/112242), 37351-26-N (18/204337, 18/947984, 26/F65166, 26/F65550, 679/022330, 679/042416, 679/062207), 37351-28-N (18/234338, 18/954985, 26/F65551, 679/022331, 679/042423, 679/072204), 37351-30-N (18/205339, 18/948986, 26/F65552, 679/042424, 679/072205, 679/122209), 37351-32-N (18/235340, 18/955987, 26/F65553, 679/042425, 679/062234), 37351-34-N (18/206341, 18/491108, 26/F65554, 679/012306, 679/042426, 679/062208), 37351-36-N (18/239342, 18/571109, 18/571503, 26/F65555, 679/022324, 679/052401, 679/062209), 37351-38-N (18/230679, 18/501110, 18/862696, 679/052402, 679/122252), 37351-40-N (147/15088L, 18/207343, 18/506128, 18/511111, 679/052411), 37351-42-N (18/581112, 679/032515), 37351-44-N (18/591113, 679/022511), 37351-46-N (18/601114), 37351-48-N (18/611115, 679/032517), 37351-50-N (18/513248, 18/621116, 18/912703, 679/032518, 679/062508), 37351-55-N (18/652407, 679/032519), 37351-60-N (18/662408), 37351-65-N (679/022512, 679/052236), 37351-70-N (18/631117, 679/052237), 37351-75-N (18/641118, 679/052238), 37351-80-N (679/052239, 679/072406), 37351-85-N (679/052240). 2. Article Number (Lot Numbers): 21241-5 (770/201905), 21241-7 (770/201906), 21242-7 (770/201901), 21243-10 (770/201901), 21244-9 (770/201905).
Recalling firm:
I.T.S. GmbH
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

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

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

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:
Article Number (Lot Numbers): 21031-3 (679/042207, 679/032240, 679/0323115, 679/052317, 26/F70606, 679/032253, 643/032501, 643/072503, 643/102501), 21031-5 (43/0015, 643/102201, 643/102201, 679/0323121, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 643/102201, 643/102201, 643/102201, 643/102201, 679/0323120, 679/0323120), 21032-11 (679/112312), 21032-3 (679/032241, 643/0623, 679/042293, 679/0323122, 679/062367, 679/052318, 643/022501, 643/062501, 643/072501, 643/102502), 21032-5 (679/122136, 679/0323143, 679/042337), 21033-3 (679/062212, 679/022301, 679/042338, 679/022302), 21033-5 (643/0629, 26/F24901, 679/012311), 21034-3 (679/062221, 679/012312, 679/072217, 679/042339), 21034-5 (643/102202, 679/012314, 679/012313), 21035-3 (679/062222, 679/042308, 643/012501, 643/0548), 21036-3 (679/062213, 679/042309, 679/112317),
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

CS100 IABP. Software Version CS100 IABP Q.01.

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

ALL 50 STATES
▸Full report

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

Recall #:
98189
Lot/product code:
All Model No; All UDI; All Serial No.
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2026

CS300 IABP. Software Version CS300 IABP C.01.

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

ALL 50 STATES
▸Full report

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

Recall #:
98189
Lot/product code:
All Model No; All UDI; All Serial No.
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 21, 2026

EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.

ALL 50 STATES
▸Full report

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

Recall #:
98397
Lot/product code:
UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
Recalling firm:
Staar Surgical AG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 21, 2026

MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.

Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.

ALL 50 STATES
▸Full report

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

Recall #:
98295
Lot/product code:
Catalog Number: MM1000 (Pack of 10) UDI (GTIN): 00850024195028 Serial Numbers: 23-0350 24-0118 24-0289 24-0290 24-0291 24-0472 24-0473 24-0474 24-0534 24-0535 24-0536 24-0658 24-0660 24-0697 25-0020 25-0021 25-0022 25-0160 25-0161 25-0162 25-0353 25-0354 25-1057 25-1058 25-1060 25-1087 23-0003 23-0046 23-0057 23-0062 23-0125 23-0126 23-0129 23-0176 23-0177 23-0179 23-0413 23-0414 24-0413 Catalog Number: MS-00009 (Pack of 10) UDI (GTIN):00850024195134 Serial Numbers: 22-0130 23-0022 23-0130 23-0178 24-0035 24-0117 24-0225 24-0235 24-0236 24-0659 24-0696 24-0719 25-0251 25-0252 Catalog Number: MP2001 UDI (GTIN): 00850024195141 Serial Numbers: 16 18 29 30 32 43 49 54 60 62 66 77 80 81 84 85 92 93 100 101 114 115 138 155 158 160 163 164 174 180 181 182 184 186 190 199 202 203 216 217 218 220 221 222 225 226 227 228 229 230 231 232 234 235 236 237 238 239 240 241 242 243 244 245 246 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 307 310 311 313 315 316 317 318 319 320 321 322 323 324 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 405 406 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 446 447 448 449 450 451 453 454 455 456 457 458 460 461 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 558 559 560 561 562 563 564 565 566 567 568 569 570 571 573 574 575 576 577 578 580 581 583 584 585 586 587 588 589 590 592 601 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 644 645 646 647 651 652 653 654 655 656 657 658 659 660 661 662 663 666 670 674 675 730 742 743 745 747 750 751 752 753 754 755 756 757 758 763 764 765 766 767 768 769 772 773 775 776 777 780 782 783 784 785 786 787 788 929 930 940 959 973 976 981 982 984 986 988 990 995 997 998 1001 1003 1004 1005 1006 1008 1009 1014 1015 1016 1092 Catalog Number: MP2015A UDI (GTIN): 00850024195219 Serial Numbers: 0010 0023 0030 0031 0032 0033 0034 0035 0036 0038 0039 0041 0042 0043 0044 0045 0046 0049 0050 0052 0054 0055 0056 0057 0059 0063 0065 0066 0070 0073 0074 0075 0076 0078 0079 0080 0081 0082 0085 0086 0087 0088 0089 0090 0091 0092 0094 0095 0096 0097 0099 0100 0101 0103 0104 0105 0106 0107 0108 0109 0110 0111 0112 0113 0114 0115 0116 0117 0118 0121 0122 0123 0124 0125 0126 0127 0128 0129 0131 0132 0133 0135 0136 0137 0138 0139 0140 0142 0143 0148 0149 0150 0151 0152 0153 0154 0155 0156 0157 0158 0159 0160 0161 0162 0164 0165 0166 0167 0168 0169 0170 0171 0172 0173 0174 0175 0176 0177 0179 0180 0181 0182 0183 0184 0186 0190 0192 0194 0197 0198 0199 0200 0201 0202 0203 0204 0205 0206 0207 0208 0209 0210 0211 0213 0215 0216 0217 0218 0219 0220 0221 0222 0223 0225 0226 0227 0229 0230 0231 0232 0234 0235 0236 0237 0238 0241 0242 0243 0245 0246 0247 0248 0249 0250 0251 0252 0253 0254 0255 0256 0257 0258 0259 0260 0262 0264 0265 0266 0267 0268 0270 0272 0273 0279 0280 0282 0283 0286 0289 0290 0291 0292 0293 0294 0296 0297 0298 0299 0300 0301 0302 0303 0304 0305 0306 0307 0308 0309 0310 0311 0312 0313 0314 0315 0316 0317 0318 0319 0321 0323 0324 0325 0326 0327 0328 0329 0330 0332 0333 0334 0335 0336 0337 0338 0339 0340 0341 0343 0344 0345 0346 0347 0348 0349 0350 0353 0355 0357 0359 0361 0362 0363 0364 0366 0368 0369 0371 0372 0373 0375 0376 0377 0379 0381 0382 0383 0384 0385 0386 0388 0389 0390 0391 0392 0393 0394 0395 0396 0397 0398 0399 0400 0401 0402 0403 0404 0405 0406 0407 0408 0409 0410 0411 0412 0413 0414 0415 0416 0417 0418 0419 0420 0421 0422 0423 0424 0425 0426 0427 0428 0429 0430 0431 0432 0433 0434 0435 0436 0437 0438 0439 0441 0443 0444 0445 0446 0449 0453 0454 0459 0466 0482 0508 0509 0510 0511 0512 0513 0514 0515 0516 0517 0518 0520 0521 0522 0523 0525 0527 0530 0531 0532 0533 0534 0535 0536 0537 0538 0539 0540 0541 0543 0544 0545 0548 0549 0550 0551 0553 0554 0555 0557 0558 0560 0563 0566 0568 0569 0570 0571 0572 0573 0575 0576 0578 0579 0602 0603 0604 0605 0606 0607 0608 0609 0610 0611 0612 0613 Catalog Number: MT2001 UDI (GTIN): 00850024195158 Serial Numbers: 3 33 34 35 36 198 202 208 210 214 215 227 228 239 240 245 246 247 247 253 263 264 268 269 270 274 277 299 302 303 304 305 3… (truncated, 7813 characters total — see the official FDA record for the full value)
Recalling firm:
Stryker Corporation
View official FDA record (opens in a new tab)