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Recalls affecting Virginia

Data last updated: September 11, 2026 at 1:08 PM UTC

17,065 recalls found
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Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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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.

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UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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UnclassifiedAnnounced August 31, 2026

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

VANTAGE GALAN 3T Model MRT-3020/MEXL-3020

There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.

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

Recall #:
98112
Lot/product code:
Model Number: MRT-3020/MEXL-3020 UDI-DI code: 04987670102615 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3020/4A MEXL-3020/5D 5DB2152002 30058153 (01)04987670102615(21)4AA2152001 MRT-3020/4A MEXL-3020/5D 5DC2262005 30075456 (01)04987670102615(21)4AB2262002 MRT-3020/4A MEXL-3020/5D 5DE2452007 30097122 (01)04987670102615(21)4AC2452003 MRT-3020/5A MEXL-3020/5D 5DB2172003 30047848 (01)04987670102615(21)5AA2172001 MRT-3020/6A MEXL-3020/7D 7DE2482014 30102813 (01)04987670102615(21)6AA2482002 MRT-3020/6A MEXL-3020/7D 7DE2472012 30108012 (01)04987670102615(21)6AA2472001 MRT-3020/7A MEXL-3020/7D 7DD2392008 30100563 (01)04987670102615(21)7AA2392001 MRT-3020/A4 MEXL-3020/D5 D5B2152013 30060527 (01)04987670102615(21)A4D2152004 MRT-3020/A4 MEXL-3020/D5 D5B2212019 30064817 (01)04987670102615(21)A4D2212006 MRT-3020/A4 MEXL-3020/D5 D5A2082005 30069306 (01)04987670102615(21)A4C2082002 MRT-3020/A4 MEXL-3020/D5 D5A2092007 30071480 (01)04987670102615(21)A4C2092003 MRT-3020/A4 MEXL-3020/D5 D5E24X2043 30072643 (01)04987670102615(21)A4F24X2010 MRT-3020/A4 MEXL-3020/D5 D5B2192016 30085151 (01)04987670102615(21)A4D2192005 MRT-3020/A4 MEXL-3020/D5 D5C2262022 30098384 (01)04987670102615(21)A4E2262008 MRT-3020/A4 MEXL-3020/D5 D5C2262021 30100803 (01)04987670102615(21)A4E2262007 MRT-3020/A4 MEXL-3020/D5 D5E2492042 30109383 (01)04987670102615(21)A4F2492009 MRT-3020/A5 MEXL-3020/S5 S5B18X2046 30007763 (01)04987670102615(21)A5B18X2011 MRT-3020/A5 MEXL-3020/S5 S5A17X2033 30031740 (01)04987670102615(21)A5A17X2008 MRT-3020/A5 MEXL-3020/S5 S5B17X2034 30034832 (01)04987670102615(21)A5B1882010 MRT-3020/A5 MEXL-3020/S5 S5A1732019 30036503 (01)04987670102615(21)A5A1732004 MRT-3020/A5 MEXL-3020/S5 S5A1742021 30040917 (01)04987670102615(21)A5A1742005 MRT-3020/A5 MEXL-3020/S5 S5C1972054 30041962 (01)04987670102615(21)A5C1972014 MRT-3020/A5 MEXL-3020/S5 S5A1732018 30042870 (01)04987670102615(21)A5A1732003 MRT-3020/A5 MEXL-3020/S5 S5B1842043 30043510 (01)04987670102615(21)A5B18X2012 MRT-3020/A5 MEXL-3020/D5 D5A2062003 30053897 (01)04987670102615(21)A5D2062015 MRT-3020/A5 MEXL-3020/S5 S5C18Y2048 30056987 (01)04987670102615(21)A5C18Y2013 MRT-3020/A5 MEXL-3020/D5 D5D23X2032 30087647 (01)04987670102615(21)A5G23X2017 MRT-3020/A5 MEXL-3020/D5 D5C2292024 30087649 (01)04987670102615(21)A5F2292016 MRT-3020/A5 MEXL-3020/S5.004 S5A1662001 30092401 (01)04987670102615(21)A5A1662001 MRT-3020/A6 MEXL-3020/D7 D7B2152015 30056208 (01)04987670102615(21)A6D2152001 MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596 (01)04987670102615(21)A7B1892001 MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608 (01)04987670102615(21)A7D2182004 MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084 (01)04987670102615(21)A7B1962002 MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571 (01)04987670102615(21)A7B1992003 MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596 MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608 MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084 MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

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

Recall #:
98168
Lot/product code:
1. 4044EG-1 UDI-DI 30351688073062 Lots 6141992 6156228 2. 4080P-2 UDI-DI 30351688006176 Lots 6141999 6142000 6147906 3. 4084P-1 UDI-DI 30351688029540 Lots 6147907 (corrected 1/22/26, removed "-LSM" suffix) 4. 4080PE UDI-DI 30351688039150 Lot 6131839 5. 4080PG UDI-DI 30351688081173 Lots 6131838 6142001 6142002
Recalling firm:
ICU Medical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Alphenix INFX-8000C, interventional fluoroscopic x-ray system

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

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

Recall #:
97970
Lot/product code:
serial numbers: W1C0632284, W4A1282279, W4A12Z2324, A2A2222381, A2A2392756, A3517001, A2A2352683, A2A2072087, A2A2072077, C1C2422647, W2A09Y2061, W2A10X2168, W4A11Y2144, A2A2232406, A2A2032038, W1D07Z2458, W2A09X2053, B2B1812645, A1C19Z2182, W4B1332362, B2A1622324, W4C1352385, W4A1292284, A1C19X2152, A1C1942058, A1C1972104, B2A1592233, B2A1792598, W2A1012081, W2A1052121, W4C1342374, B2B1872766, A4562105, W2A0972027, A1C2052199, A2A21X2339, W2A1012082, W4C1342369, W1D07Z2449, A1C1942065, A2A2132228, A2A2172285, A2A2117001, W1D06Z2357, A2A2282477, A2A2232405, W1B08X2034, A2A2182313, W4A1232210, A2A2262452, B2A16X2449, B2B1862743, B2B1872751, W1D0697014, W1C05X2229, B2A1542162, A2A21Z2364, A2A2392751, B2A1722527, A2A22Z2566, B4582115, W4C1372400, A2A2362690, A2A2252436, A2A2292510, B2A1582209, B2A1472014, W1D0732376, A2A2252439, W1D0732374, A1C1972105, A1C1972112, B4602126, W1B08Z2063, A2A2152265, A2A2132230, A2A2282491, A2A2262445, A2A22Y2550, A2A22X2528, W4A1212180, W4A1212176, W4A1212177, A1C1992141, W4A1182110, W4A11Z2163, W1D0812466, B2B18Y2816, B2B1832693, A1C1952078, A2A2062070, W2A09Z2077, A1C19Y2174, W1D0722372, A2A22X2518, A3542008, B2A1472020, W4A1242224, W4A1312348, A2A2172280, W4D1422466, W4A1142069, A2A2172287, A2A2342657, A2A2432872, B2A1552176, B2B1812657, B2B1872765, W4A1342373, B2A1682407, W4A11Z2170, W4C1342364, W4C1342365, W4A1172092, A2A2172281, W2A1072143, W4A1292281, A2A2242426, A2A2392761, A3612061, A1A2162240, A2A23Z2814, B2B1872760, A2A2262456, A1C2042197, B2A14Z2085, W4C1352377, W4A1252245, A1C19Z2178, A2A2292499, W4A1242221, W1D0872524, A1C19Z2188, A1C19X2158, A2A2052053, B2B1862731, B2A1752550, B2B1832678, B2B1852708, B2B1852710, B2B1852707, W1C0582207, W1C05Y2242, W1D0722370, W4A1272267, W2A1062127, B2A1742539, B2B1922842, A2A2062066, B2A16Y2469, W4A1122048, B2A1662369, W4A1122039, B5512160, A2A2122205, B2B1822664, B2B1822670, A2A2292498, W4D13Y2442, A2A2122197, A2A2192330, A2A2132216, A2A22X2522, A2A2432885, A2A2422855, W2A1012091, W1C05X2224, B2A1622310, A1C1972111, B2B1892787, A1C1952080, A1B18Y7002.
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm

The supplier manufactured anatomical left plates with an incorrect thread orientation.

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

Recall #:
98214
Lot/product code:
Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294;
Recalling firm:
Tyber Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body

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

Recall #:
98150
Lot/product code:
UDI-DI: 00840619026059, 00840619006785. REF/Lot(Expiration): 011-D1000/14015455(5/1/2029), 14044313(6/1/2029), 14228823(12/1/2029), 14274294(1/1/2030); 01C-D1000/14171414(10/1/2029), 14304670(2/1/2030); 055-D1000/13772668(9/1/2028), 13778926(9/1/2028), 13791786(10/1/2028), 13794986(10/1/2028), 13797963(10/1/2028), 13801102(10/1/2028), 13806764(10/1/2028), 13812991(11/1/2028), 13822705(11/1/2028), 13828556(11/1/2028), 13833879(11/1/2028), 13838937(12/1/2028), 13867515(1/1/2029), 13875052(1/1/2029), 13876502(1/1/2029), 13876503(1/1/2029), 13882254(1/1/2029), 13882256(1/1/2029), 13887995(1/1/2029), 13887996(1/1/2029), 13894349(2/1/2029), 13894350(2/1/2029), 13903971(2/1/2029), 13903972(2/1/2029), 14045054(6/1/2029), 14045055(6/1/2029), 14049379(6/1/2029), 14049404(6/1/2029), 14063784(6/1/2029), 14063785(6/1/2029), 14071890(7/1/2029), 14071891(7/1/2029), 14071892(7/1/2029), 14087320(7/1/2029), 14090798(7/1/2029), 14110500(8/1/2029), 14131560(8/1/2029), 14144999(9/1/2029), 14145000(9/1/2029), 14150873(9/1/2029), 14150874(9/1/2029), 14150875(9/1/2029), 14170224(10/1/2029), 14170226(10/1/2029), 14179702(10/1/2029), 14179704(10/1/2029), 14179706(10/1/2029), 14208522(11/1/2029), 14208523(11/1/2029), 14212866(11/1/2029), 14212870(11/1/2029), 14216154(11/1/2029), 14216155(11/1/2029), 14224623(11/1/2029), 14248560(12/1/2029), 14248561(12/1/2029), 14274291(1/1/2030), 1427429291/1/2030), 14278257(1/1/2030), 14278258(1/1/2030), 14278259(1/1/2030), 14278260(1/1/2030), 14300970(2/1/2030), 14300972(2/1/2030), 14303936(2/1/2030); D1000/13768000(9/1/2028), 13772666(9/1/2028), 13778922(9/1/2028), 13778923(9/1/2028), 13778925(9/1/2028), 13791783(10/1/2028), 13791784(10/1/2028), 13791785(10/1/2028), 13792328(10/1/2028), 13794980(10/1/2028), 13794982(10/1/2028), 13794984(10/1/2028), 13801099(10/1/2028), 13801100(10/1/2028), 13801101(10/1/2028), 13806761(10/1/2028), 13806762(10/1/2028), 13806763(10/1/2028), 13812988(11/1/2028), 13812989(11/1/2028), 13812990(11/1/2028), 13822693(11/1/2028), 13822697(11/1/2028), 13822701(11/1/2028), 13825588(11/1/2028), 13828548(11/1/2028), 13828551(11/1/2028), 13828553(11/1/2028), 13833876(11/1/2028), 13833877(11/1/2028), 13833878(11/1/2028), 13838931(11/1/2028), 13838933(12/1/2028), 13838935(11/1/2028), 13848442(12/1/2028), 13848444(12/1/2028), 13848445(12/1/2028), 13854647(12/1/2028), 13854648(12/1/2028), 13854649(12/1/2028), 13858987(12/1/2028), 13859857(12/1/2028), 13859858(12/1/2028), 13859859(12/1/2028), 13867512(1/1/2029), 13867514(1/1/2029), 13876507(1/1/2029), 13876508(1/1/2029), 13876509(1/1/2029), 13882259(1/1/2029), 13882260(1/1/2029), 13887205(1/1/2029), 13887206(1/1/2029), 13887997(1/1/2029), 13894351(1/1/2029), 13894352(2/1/2029), 13894353(2/1/2029), 13903974(2/1/2029), 13903975(2/1/2029), 13903976(2/1/2029), 13903977(2/1/2029), 13910270(2/1/2029), 13910272(2/1/2029), 13938363(3/1/2029), 13938364(3/1/2029), 13938366(3/1/2029), 13943704(3/1/2029), 13943708(3/1/2029), 13943712(3/1/2029), 13943720(3/1/2029), 13949234(3/1/2029), 13953949(3/1/2029), 13953954(4/1/2029), 13953956(4/1/2029), 13953958(4/1/2029), 13955847(4/1/2029), 13959937(4/1/2029), 13959944(4/1/2029), 13959950(4/1/2029), 13959956(4/1/2029), 13971720(4/1/2029), 13971744(4/1/2029), 13971752(4/1/2029), 13971761(4/1/2029), 13971773(4/1/2029), 13979279(4/1/2029), 13979290(4/1/2029), 13979293(4/1/2029), 13979298(4/1/2029), 13979303(4/1/2029), 13979306(4/1/2029), 13979308(4/1/2029), 13982887(4/1/2029), 13982888(4/1/2029), 13986330(4/1/2029), 13986339(4/1/2029), 13986376(5/1/2029), 13986393(4/1/2029), 13986399(4/1/2029),13986406(4/1/2029), 13986440(4/1/2029), 13999996(5/1/2029), 13999997(5/1/2029), 13999999(5/1/2029), 14000000(5/1/2029), 14000001(5/1/2029), 14000002(5/1/2029), 14000003(5/1/2029), 14015459(5/1/2029), 14015462(5/1/2029), 14015463(5/1/2029), 14015464(5/1/2029), 14015467(5/1/2029), 14021608(5/1/2029), 14021610(5/1/2029), 14021611(5/1/2029), 14021612(5/1/2029), 14021613(5/1/2029), 14027546(5/1/2029), 14027547(5/1/2029), 14027548(5/1/2029), 14027549(5/1/2029), 14027551(5/1/2029), 14027552(5/1/2029), 14027553(5/1/2029), 14036497(5/1/2029), 14036498(5/1/2029), 14036499(5/1/2029, 14036500(6/1/2029), 14036501(6/1/2029), 14036502(6/1/2029), 14036503(6/1/2029), 14037604(6/1/2029), 14037605(6/1/2029), 14041790(6/1/2029), 14041792(6/1/2029), 14041793(6/1/2029), 14041795(6/1/2029), 14041797(6/1/2029), 14041798(6/1/2029), 14041800(6/1/2029), 14056392(6/1/2029), 14056393(6/1/2029), 14056395(6/1/2029), 14056397(6/1/2029), 14056398(6/1/2029), 14056399(6/1/2029), 14056400(6/1/2029), 14063790(6/1/2029), 14063791(7/1/2029), 14063792(7/1/2029), 14071894(7/1/2029), 14071895(7/1/2029), 14087321(7/1/2029), 14087322(7/1/2029), 14087323(7/1/2029), 14090800(7/1/2029), 14090801(8/1/2029), 14097661(8/1/2029), 14097662(8/1/2029), 14100193(8/1/2029), 14100198(8/1/2029), 14110501(8/1/2029), 14110502(8/1/2029), 14110503(8/1/2029), 14110505(8/1/2029), 14115072(8/1/2029), 14115073(8/1/2029), 14115074(8/1/2029), 14115075(8/1/2029), 14115076(8/1/20… (truncated, 6906 characters total — see the official FDA record for the full value)
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No

The supplier manufactured anatomical left plates with an incorrect thread orientation.

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

Recall #:
98214
Lot/product code:
Model No: 02.426.691S; UDI-DI: 00196449020522; Lot Number: 291293
Recalling firm:
Tyber Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

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

Recall #:
98206
Lot/product code:
Material Number: 11330003; UDI-DI: 04056869263168; Serial Numbers: 127226, 127156, 127268, 127260, 127217, 127313, 127272, 127275, 127276, 127206, 127118, 127152, 127091, 127183, 127166, 127125, 127264, 127220, 127104, 127037, 127136, 127201, 127137, 127221, 127205, 127176, 127297, 127245, 127138, 127314, 127310, 127195, 127259, 127093, 127085, 127215, 127235, 127208, 127256, 127036, 127180, 127242, 127115, 127290, 127146, 127039, 127315, 127203, 127071, 127170, 127318, 127273, 127101, 127046, 127133, 127246, 127083, 127240, 127241, 127299, 127068, 127224, 127139, 127251, 127119, 127265, 127311, 127185, 127111, 127112, 127102, 127249, 127266, 127280, 127132, 127227, 127277, 258044, 127142, 127289, 127075, 127144, 127130, 127131, 127080, 127124, 127271, 127169;
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.

Product not cleared by the FDA.

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

Recall #:
98472
Lot/product code:
Model No. 41972; No UDI; Lot Code: 6933289812337.
Recalling firm:
Altruan GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

Product not cleared by the FDA.

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

Recall #:
98472
Lot/product code:
Model No. AL-42153; No UDI; Lot Code: 6952804827274.
Recalling firm:
Altruan GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

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

Recall #:
98206
Lot/product code:
Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

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

Recall #:
98237
Lot/product code:
Material Number (UPN): M00553680; UDI-DI: 191506008086; Lot Numbers: 35950784, 35960771, 35960772, 36156260, 36156261, 36165653, 36167912, 36241714, 36401105, 36408034, 36421237, 36447549, 36447550, 36520894, 36530482, 36530483, 36530484, 36533326, 36536257, 36536258, 36570788, 36570789, 36578110, 36581584, 36603297, 36611362, 37014108, 37429734, 37429735, 37433804, 37433805, 37440329, 37451303, 37456593, 37495326, 37511241, 37519092, 37519093, 37780825;
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

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

Recall #:
98237
Lot/product code:
Material Number (UPN): M00553690; UDI-DI: 191506008093; Lot Numbers: 35960775, 35960777, 35962525, 36100561, 36101748, 36111316, 36154532, 36154533, 36241501, 36251362, 36253016, 36293839, 36301625, 36303192, 36420219, 36425888, 36449561, 36458830, 36461449, 36478580, 36492661, 36495673, 36573597, 36573598, 36573599, 36574152, 36576474, 36584299, 36604665, 36731807, 36731808, 36737997, 36743059, 36743200, 36904231, 36904232, 36904233, 36906587, 36907000, 36907001, 36907032, 37217612, 37217613, 37217614, 37440330, 37495327, 37511242, 37602825, 37602826, 37689946, 37694053, 37694054, 37764851, 37764852, 37995048, 37995049, 37995050, 38025042, 38025043.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

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

Recall #:
98237
Lot/product code:
Material Number (UPN): M00553520; UDI-DI: 8714729904540; Lot Numbers: 36067957, 36067958, 36067959, 36067960, 36067961, 36099410, 36102139, 36111317, 36111318, 36111319, 36132439, 36132800, 36136724, 36136725, 36144054, 36154527, 36154528, 36154529, 36156019, 36164532, 36164990, 36176206, 36176207, 36177448, 36191239, 36199389, 36199390, 36217761, 36241713, 36251361, 36252913, 36271441, 36271442, 36281910, 36281911, 36292639, 36292680, 36292681, 36293836, 36300838, 36317858, 36317859, 36318240, 36323786, 36323787, 36331036, 36331037, 36331038, 36331039, 36397921, 36397922, 36397923, 36421238, 36424644, 36424645, 36427248, 36446498, 36447200, 36447201, 36449569, 36449570, 36449571, 36458829, 36459567, 36459568, 36459569, 36459570, 36461959, 36462320, 36468392, 36468393, 36468394, 36502795, 36506161, 36506163, 36509326, 36520053, 36523274, 36528114, 36536932, 36536933, 36548030, 36548031, 36548850, 36548851, 36552680, 36559035, 36559036, 36567446, 36567447, 36567448, 36574150, 36581585, 36581586, 36582790, 36582791, 36585188, 36585189, 36591087, 36592499, 36592660, 36596040, 36596041, 36609818, 36609819, 36610400, 36610401, 36621583, 36621584, 36634546, 36634547, 36664793, 36673195, 36673557, 36673558, 36675688, 36675689, 36675690, 36675692, 36677844, 36677845, 36677846, 36680231, 36680232, 36683260, 36683261, 36683262, 36693971, 36693972, 36717713, 36717714, 36717715, 36717819, 36721863, 36731805, 36731806, 36738965, 36738966, 36743835, 36750922, 36750924, 36753179, 36753400, 36781577, 36781578, 36781579, 36784378, 36784379, 36788332, 36788333, 36788334, 36792650, 36799316, 36832750, 36832837, 36832838, 36833682, 36834573, 36843542, 36844231, 36846161, 36846163, 36864951, 36864952, 36865501, 36865502, 36865504, 36865553, 36868065, 36872344, 36872346, 36878419, 36884609, 36884612, 36884613, 36895367, 36895368, 36896664, 36907033, 36907249, 36907378, 36907400, 36914565, 36915206, 36915207, 36916329, 36916330, 36917403, 36917404, 36917993, 37000847, 37003365, 37423232, 37423233, 37427258, 37427259, 37427360, 37427361, 37427362, 37437936, 37438283, 37438286, 37438287, 37439978, 37440320, 37451304, 37456594, 37457216, 37457217, 37457269, 37459571, 37463623, 37463624, 37463625, 37463628, 37469756, 37469757, 37469758, 37470669, 37472148, 37475121, 37475122, 37481983, 37486079, 37518915, 37518916, 37518917, 37519094, 37532420, 37532421, 37533309, 37543372, 37558499, 37558542, 37567252, 37567253, 37567400, 37568848, 37568849, 37571930, 37685005, 37686597, 37689957, 37689958, 37698144, 37704842, 37761033, 37761034, 37775246, 37776579, 37776720, 37776721, 37780826, 37785688, 37785689, 37811064, 37817121, 37823587, 37823588, 37826529, 37826530, 37827570, 37834839, 37836866, 37836867, 37842827;
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Alphenix INFX-8000V, interventional fluoroscopic x-ray system

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

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

Recall #:
97970
Lot/product code:
serial numbers: B2A1522117, E0514103, B2A15X2238, B2A1792589, A2A2242418, A2A21X2345, B2A1692413, A2A2152263, A2A2262450, A2A22Z2576, W4A1252250, A2A20Z2167, W4A10X2001, A2A2412831, W1C0552181, W1D0842501, W4D13Z2452, W4A1322350, W4D1422467, B2A1472002, A1C1982123, W2A1062134, W1B08X2042, W2A1072139, W4A1242220, A2A2382741, B2A17Z2627, A2A2152264, W4C1362387, W4D1422465, D4W1262257, W1D0892543, W4D1462478, W4A1182118, W4A11X2133, W4A11Z2167, N/A Deinstalled, A1B18Z7003, W4A1252243, DFP800A-0001, A3552017, W2A1092165, W1D0882537, A2A2122203, W4A10Z2022, W4B1332361, A2A23Y2788, W4A12Z2328, B2A1662374, W4A12Z2329, B2A1622309, B2A14X2056, A2A2272459, A2A2172291, W4A1132061, W1D0832488, W1D0882536, W2A0962022, W2A0982038, W2A0972026, B2A1642351, A2A2152255, W1D0752392, A2A2182308, A2A2412836, A2A2112189, A2A21X2336, A1C19Y2164, A1C1942056, A2A2192328, A2A2332643, W4C1372398, A2A22Y2553, A2A2132226, W4A1262256, B2A1472013, W2A1022097, W2A1022094, W4A10Z2017, W1B08Y2055, B2A1492051, B2A1492052, W4A10Z2021, W4A12Z2332, W4D1412463, W4A1122040, B2B1862727, B2B1812651, B2A1662376, B2A16X2448, B2A1742547, W4A1242230, W4A1272271, G3514035, B2A17X2601, W1D07Z2454, W4A1272272, A2A2142238, B2B1862746, B2B18X2800, A2A2022014, A2A2032029, A2A2172288, A2A2122199, A2A2152258, A2A2012004, W4A10X2004, B2B18X2810, B2B1952847, A2A2142244, A2A2172297, W2A0992045, W4A1262253, W4A1282278, W4A12Z2330, W4A1312340, W2A09Z2075, B2A1652363, W4A1272266, W4A1162079, A2A2152253, W2A1092160, W4D1452476, W1D07Y2445, W2A1072147, A1C1962090, A1C1962089, B2A1652362, W4D14Y2481, A2A20Z2157, A2A22Y2547, A2A2162266, W4A1212183, W4A1212189, W4A1212190, W4A11Z2172, W4A1212178, W4A1212191, W4A1212185, W4A1212184, W4A1132060, W4A1242222, B2A1612295, B2A16Y2468, W4A1222003, A4512077, W2A0982043, W1D0892547, W2A0972030, W2A1042109, A2A2322602, W2A1047001, A1C1982121, A2A2332647, B2A16Y2455, B2A16Y2456, B2A17X2608, B2A17X2605, B2A17X2607, B2A1592231, A2A2232398, B2B1822666, W1B08Z2064, W1B08Z2067, A1C1942063, A1B1922042, B2B1842698, B2B1882777, B2B1892792, W4A1162083, A1C1962094, W4A1222202, W4A12X2299, B2A15X2243, A2A20Y2153, W2A1072141, W4A10Z2014, W4A1142064, W4A1252239, W2A1062136, A2A21X2344, W1D0697017, A2A2022026, A2A22Z2572, W1D0882538, A2A2142237, A2A20Z2161, A1C1992148, W4A1252241, B2A16X2454, W4A1242223, W4A1162089, A2A2242410, B2A1622320, W1D0812470, A2A2182307, A2A2332638, W4A1272240, B2A16Y2474, A2A2262444, A1C1952074, B2A1612300, W4A10Y2006, B2A1582203, W4A1242231, W4A12X2300, B2A1522121, B2A1532152, A2A2142245, B2A1512107, W4D1452473, A1C1992135, A2A2132229, A2A2092109, A2A2052055, A2A2142241, W2A09Y2065, A2A2062064, A2A21X2347, W4C1382414, B2A16Z2492, B2B1582210, B2A14X2062, B2A14Z2097, B2B1882769, W2A0962024, W4A1272261, W2A1052126, W2A09Y2064, B2A1622321, W4A10Z2018, W4A1262254, W4A1182121, W4C13X2433, W4C13X2432, W4C1372401, W1C0632285, A2A2282476, W4C1362389, W4A1322353, B2A15Y2252, W2A1042114, W2A1052125, W2A1072142, W4A1312343, W4A1142063, W4C1362388, W4C1352376, W4C1352378, B2B1862733, A1C1962097, B2B2032825, B2A1592224, A1C1962088, W1B08X2026, W1D0872529, W1D0732379, B2B1872763, B2A17Z2630, B2A17Z2629, W4A11X2132, W4A1112033, F1514114, W4A1122043, W4A1242237, W1D0697015, W1B08X2036, A2A2132227, W1B08Y2050, W4A1112035, W2A09Z2078, A2A2292515, A2A2422852, B2A1582215, W4A1272262, A1C1942064, W4C1342371, A1C19X2155, W4A1212186, W4A1212175, A2A2072088, B2A16Y2467, B2A1612293, B2B18Z2830, B2B1812654, W4A11Z2169, W4A1222196, W4A1212174, W1D0862519, W4A1217002, W4A1242225, B2A14X2057, A2A2432873, W1D0892545, A2A2232396, A2A2382740, W4D1452474, B2A17Z2634, B2B1842701, W2A1072145, F9624025, B2A1532147, A2A2262447, A2A2142246, B2A14Z2099, A2A2152262, B2B1832680, A2A2242429, W1D0782416, B2B1862728, B2B1862735, B2A1642352, B2A16Z2480, W4A1312344, A2A2082098, W2A0982041, B2A1772578, A2A2092106, W4A1162085, B2B1832692, A2A2142236, B2A1552177, A1B1932051, A1B1932049, B2A1682401, W4A12Z2323, B2A1712502, B2A17X2604, W4A12Y2316, B2A1712504, B2A1512106, A2A20X2083.
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Alphenix INFX-8000H, interventional fluoroscopic x-ray system

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

ALL 50 STATES
▸Full report

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

Recall #:
97970
Lot/product code:
serial numbers: D2A1672385, A2A20Z2165, B2A1692426.
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

ALL 50 STATES
▸Full report

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

Recall #:
98237
Lot/product code:
Material Number (UPN): M00553530; UDI-DI: 8714729904557; Lot Numbers: 35985705, 35986358, 36147098, 36147222, 36165642, 36176423, 36190575, 36191222, 36194448, 36218745, 36227778, 36227779, 36241500, 36271259, 36280398, 36293880, 36300839, 36301620, 36343103, 36343104, 36364646, 36425887, 36469811, 36471228, 36491879, 36492660, 36506029, 36510220, 36510221, 36513401, 36513402, 36513403, 36517139, 36517220, 36525208, 36525209, 36525210, 36534514, 36534518, 36536259, 36536480, 36536481, 36551000, 36551001, 36642564, 36642565, 36642756, 36645775, 36663654, 36677842, 36677843, 36682759, 36684887, 36684888, 36730665, 36730666, 36747824, 36747825, 36753898, 36753899, 36757493, 36757494, 36761827, 36766370, 36766371, 36783265, 36792467, 36792468, 36792469, 36792470, 36792471, 36799315, 36815090, 36815092, 36832774, 36833683, 36836357, 36844783, 36845422, 36846169, 36846176, 36851617, 36851792, 36853596, 36865505, 36873631, 36873632, 36873906, 36874863, 36904228, 36904229, 36904230, 36907002, 36907003, 36907004, 36907028, 37102533, 37102534, 37102535, 37102536, 37102537, 37459567, 37459568, 37459569, 37459570, 37463133, 37470670, 37498192, 37511243, 37519095, 37519096, 37844029, 37519097, 37520927, 37530320, 37530321, 37530333, 37533308, 37541933, 37571927, 37571928, 37579364, 37579366, 37579367, 37580630, 37585525, 37585526, 37589261, 37589262, 37594668, 37649481, 37649482, 37649483, 37650631, 37694052, 37699011, 37699012, 37708202, 37779125, 37779126, 37780822, 37780823, 37780824, 37823589, 37823590, 37827568, 37827569, 37833165, 37833176, 37834499;
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Alphenix INFX-8000F, interventional fluoroscopic x-ray system

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

ALL 50 STATES
▸Full report

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

Recall #:
97970
Lot/product code:
serial numbers: W1C0582204, B2A1582208, W2A1052118, A3582035, A2A2362689, B2B18Y2813, W1D07Y2447, B4582113, W2A1042111, W1C0622270, A3592048, W4A11X2138, W2A09Y2060, B2A16Z2476, W2A09Y2066, W4A1122041, B2A1482032, B2A1482027, A2A2252435, W1D0722369, B2B15Y2247, W1B0542168, B2A1492049, W1D0722371, A2A2032031, A1C1972103, W4C1352375, B2B1862737, W1D0842499, W4A1212179, W4A11Z2171, W4A11Z2173, W1C0652298, B2A1692419, B2A1552170, A2A21Y2350, W4A1242226, B2B1952848, A1C19Z2180, B2A1662371, W1D0892555, W1D0822476, W1D06Z2356, B2A1682394, B2A17Y2619, B2A17Y2624, W1D0762406, A2A2172283, W4A11Y2155, A2A2272460, W1D0832487, B2B1822667, A1C1992146, W4A1112031, W4C1382409, A2A2292508, W4A13X2015, W4A1192130, B2A1712510, B2A1762562, W4A1142066, W1C0622274, A4552098, W4A12X2298, W1D0812460, A4542088, W1D0712363, A2A21X2348, W1C0552179, W4A1142065, B2A17Z2626, W4D13Y2444, W2A1042110, A2A20Z2159, W4A11Y2147, W1C0642289, B2B1852720, B2A1592219, W4B13Y2016, B2B1922843, B2B1822668, W4B12Y2312, A2A2052056, A2A2062062, A2A2072075, A2A2042041, A1C19Z2181, W2A1092163, A2A2012005, A2A20Y2147, A1C19Y2161, B2A1612289, W4A1112030, W2A0982042, B2B18X2802, B2A1712503, B2A1712499, B2A14Z2084.
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

ALL 50 STATES
▸Full report

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

Recall #:
98237
Lot/product code:
Material Number (UPN): M00553560; UDI-DI: 8714729951100; Lot Numbers: 35793920, 35952745, 35961004, 35995006, 35995007, 35995165, 36001950, 36001951, 36001952, 36001953, 36002902, 36002903, 36002904, 36003946, 36003947, 36003948, 36012845, 36012846, 36012847, 36012848, 36015761, 36021049, 36021050, 36021051, 36021052, 36027054, 36027055, 36027056, 36027057, 36027058, 36027059, 36027060, 36027061, 36038410, 36038411, 36040000, 36040001, 36040002, 36040003, 36040004, 36048795, 36048796, 36048797, 36048798, 36049282, 36049283, 36049284, 36050387, 36050388, 36050389, 36059222, 36059223, 36059224, 36059225, 36062077, 36062078, 36062079, 36064449, 36065116, 36065117, 36067962, 36067963, 36067964, 36069958, 36069959, 36070600, 36070608, 36070609, 36070610, 36070611, 36072736, 36072737, 36092333, 36092334, 36092335, 36099411, 36099412, 36099413, 36101743, 36101744, 36101745, 36101746, 36101747, 36102812, 36102813, 36102814, 36135590, 36135591, 36144122, 36144123, 36147096, 36147097, 36154534, 36154536, 36154537, 36154538, 36155116, 36155117, 36156264, 36156265, 36164534, 36164535, 36164536, 36165655, 36165656, 36165657, 36165658, 36197586, 36197587, 36197588, 36197589, 36199391, 36200602, 36200603, 36207756, 36207757, 36207758, 36209378, 36209379, 36218689, 36218690, 36218746, 36218747, 36219228, 36271447, 36271448, 36271456, 36271457, 36271458, 36271459, 36271840, 36303991, 36303992, 36303993, 36310699, 36310760, 36310761, 36310762, 36310763, 36310764, 36310765, 36310766, 36310767, 36310768, 36310769, 36447543, 36447544, 36447545, 36447546, 36449567, 36449568, 36458833, 36458834, 36461125, 36478581, 36478582, 36478583, 36478584, 36478585, 36481333, 36481334, 36487762, 36487763, 36487764, 36487765, 36493311, 36493313, 36493314, 36494812, 36494813, 36503314, 36503315, 36503316, 36503317, 36503459, 36504640, 36504702, 36509327, 36517739, 36517821, 36517822, 36519644, 36533327, 36533328, 36548037, 36548038, 36548039, 36548060, 36548061, 36551002, 36551003, 36551004, 36559039, 36559580, 36559581, 36559582, 36559583, 36560842, 36560843, 36562844, 36562845, 36565931, 36566528, 36567449, 36570785, 36570786, 36570787, 36572359, 36581587, 36583578, 36583579, 36591069, 36591070, 36591071, 36591072, 36612260, 36612261, 36616444, 36616445, 36619789, 36619790, 36619791, 36619792, 36619793, 36621321, 36621322, 36621323, 36625032, 36625033, 36625034, 36625035, 36626350, 36626351, 36626352, 36633245, 36633246, 36640831, 36641049, 36641909, 36641910, 36642073, 36642074, 36642075, 36642562, 36643731, 36643732, 36645532, 36645533, 36645534, 36647015, 36662774, 36662775, 36662776, 36662778, 36662779, 36664061, 36664062, 36664063, 36664064, 36664065, 36664567, 36664568, 36664794, 36664796, 36665694, 36665695, 36669412, 36669413, 36669414, 36669415, 36669416, 36669417, 36669418, 36674810, 36674811, 36674812, 36674813, 36677847, 36683263, 36684615, 36685905, 36685906, 36804376, 36814735, 36816919, 36818381, 36818382, 36821877, 36823193, 36823194, 36828324, 36828325, 36829194, 36829196, 36835382, 36835383, 36838544, 36838545, 36838546, 36838547, 36839663, 36839664, 36847979, 36848665, 36848666, 36851793, 36851794, 36853105, 36853106, 36853594, 36853595, 36854299, 36856185, 36856186, 36856187, 36856188, 36856340, 36856341, 36856342, 36866851, 36866852, 36866853, 36868980, 36868981, 36868982, 36868983, 36868984, 36869884, 36869885, 36869886, 36869887, 36869888, 36869889, 36869890, 36869891, 36875736, 36875737, 36877081, 36877082, 36877084, 36877085, 36880763, 36880764, 36897772, 36897773, 36959806, 36959807, 36994050, 36994051, 36994052, 36995011, 36995012, 36999167, 36999494, 37004725, 37004726, 37004727, 37059011, 37060652, 37067633, 37069356, 37069357, 37075264, 37075265, 37078233, 37078234, 37093209, 37093210, 37093302, 37093303, 37096513, 37096514, 37099739, 37132500, 37132501, 37132502, 37134087, 37137422, 37137423, 37140068, 37152588, 37153325, 37157514, 37161889, 37161890, 37164067, 37164068, 37167102, 37167103, 37167775, 37176653, 37176657, 37194095.37204177, 37204178, 37204179, 37204240, 37204241, 37204809, 37204810, 37204811, 37207470, 37207471, 37208948, 37217600, 37217605, 37217607, 37240010, 37240011, 37252330, 37252331, 37252333, 37252334, 37252335, 37257420, 37257421, 37257422, 37257423, 37261686, 37262942, 37262943, 37262949, 37262950, 37263184, 37263185, 37263554, 37263555, 37268080, 37268081, 37268098, 37269066, 37269067, 37269068, 37272106, 37272107, 37272903, 37272904, 37273840, 37273841, 37274479, 37274863, 37275620, 37276239, 37276361, 37276363, 37276364, 37308911, 37323226, 37323227, 37323228, 37323229, 37324379, 37325180, 37325181, 37325182, 37325354, 37331113, 37379513, 37380940, 37380941, 37380942, 37382298, 37382299, 37384504, 37384505, 37386277, 37386278, 37443960, 37443961, 37443962, 37451306, 37451307, 37456598, 37457260, 37460647, 37460648, 37461035, 37461036, 37463128, 37463129, 37501715, 37501716, 37501717, 37510239, 37511240, 37514184, 37514185, 37514972, 37524755, 37524756, 37524758, 37530261, 37536574, 3… (truncated, 5948 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

ALL 50 STATES
▸Full report

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

Recall #:
98206
Lot/product code:
Material Number: 11330002; UDI-DI: 04056869231051; Serial Numbers: 125205, 125250;
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

ALL 50 STATES
▸Full report

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

Recall #:
98237
Lot/product code:
Material Number (UPN): M00553680; UDI-DI: 8714729951179; Lot Numbers: 35961006 35961007 35962524 35967379 35968520, 35968521, 35968597, 35968598, 35971077, 35971078, 35971079, 35972100, 35982272, 35982273, 35982274, 35982275, 35982276, 35982277, 35982278, 35982279, 35982420, 35982424, 35982425, 35985313, 35985314, 35993619, 35993720, 35993721, 36109761, 36109763, 36109764, 36109765, 36109766, 36111314, 36111315, 36118993, 36118994, 36122066, 36122067, 36122075, 36132801, 36132802, 36132803, 36132804, 36134972, 36144058, 36144059, 36144120, 36144121, 36174475, 36174476, 36178005, 36187588, 36187589, 36187687, 36187688, 36188887, 36188888, 36188889, 36194446, 36194447, 36197239, 36198580, 36217768, 36217769, 36217770, 36227341, 36227342, 36227343, 36228603, 36228604, 36228605, 36235934, 36236151, 36240589, 36240590, 36241715, 36241716, 36241717, 36251363, 36251364, 36253000, 36253008, 36253041, 36260860, 36260861, 36260862, 36261599, 36261780, 36261781, 36261834, 36261835, 36280395, 36280396, 36280397, 36281912, 36281913, 36281914, 36283860, 36292682, 36292683, 36292684, 36292689, 36292690, 36292691, 36294495, 36301621, 36301622, 36301623, 36301624, 36302290, 36302291, 36302292, 36319024, 36319025, 36319026, 36320016, 36320017, 36323789, 36323790, 36324720, 36325159, 36325560, 36325568, 36325569, 36332101, 36332102, 36341577, 36342114, 36342418, 36352008, 36352009, 36355049, 36355050, 36355752, 36359567, 36362263, 36362264, 36362265, 36363150 36363151 36364647 36372361 36372362, 36377757, 36378548, 36380549, 36388531, 36390612, 36396985, 36399492, 36403441, 36408983, 36408984, 36417820, 36417821, 36418721, 36418722, 36424650, 36424651, 36424652, 36425889, 36425890, 36425891, 36425892, 36462323, 36462324, 36469427, 36469428, 36469812, 36472250, 36472253, 36472254, 36475370, 36478478, 36478479, 36572740, 36572741, 36573582, 36573583, 36573587, 36573588, 36573589, 36573590, 36591073, 36591074, 36591075, 36603384, 36603385, 36603386, 36604188, 36604189, 36604190, 36604191, 36604748, 36604749, 36607249, 36607250, 36607251, 36607252, 36607253, 36610818, 36610819, 36611060, 36615703, 36615704, 36621589, 36621590, 36623324, 36623325, 36623326, 36693849, 36693850, 36693851, 36693852, 36694699, 36695020, 36695021, 36695023, 36698247, 36698249, 36698251, 36698527, 36698528, 36698529, 36698530, 36698531, 36698532, 36706712, 36706713, 36706714, 36706715, 36709766, 36709767, 36709768, 36709769, 36713255, 36713256, 36713257, 36713258, 36717717, 36717718, 36717719, 36717800, 36717801, 36717802, 36718966, 36718967, 36723909, 36723910, 36728154, 36764237, 36764238, 36767449, 36767450, 36771884, 36771885, 36771886, 36785593, 36788793, 36788794, 36788795, 36795369, 36795370, 36796430, 36796431, 36804013, 36804375, 36839665, 36895362, 36895363, 36895364, 36958216, 36958217, 36962750, 36970218, 36970219, 36980309, 36980310 36981855 36981856 36982694 36983909, 36985933, 36988630, 36988631, 36988632, 36990382, 36990383, 36991168, 36991170, 36991683, 36992721, 37014102, 37014103, 37014104, 37027339, 37028180, 37028181, 37030756, 37032104, 37036344, 37036345, 37037505, 37037506, 37040169, 37041012, 37041435, 37041436, 37046449, 37046450, 37046928, 37046929, 37048665, 37049464, 37049465, 37049874, 37050321, 37050322, 37050323, 37055465, 37055466, 37055467, 37056013, 37056014, 37057032, 37059006, 37059010, 37094844, 37106164, 37106583, 37131143, 37131144, 37131145, 37131146, 37177253, 37177271, 37177272, 37179955, 37179956, 37180902, 37180903, 37182323, 37183490, 37188257, 37188258, 37197563, 37197578, 37198908, 37199019, 37199360, 37199361, 37199972, 37199973, 37209169, 37209170, 37209171, 37211282, 37211285, 37212243, 37212244, 37212245, 37212246, 37213246, 37213247, 37213248, 37213249, 37240012, 37240013, 37240236, 37240237, 37240249, 37240250, 37240252, 37240254, 37242247, 37242248, 37242249, 37243754, 37243755, 37243756, 37247304, 37247305, 37247306, 37283604, 37283605, 37291851, 37291852, 37292951, 37292952, 37296017, 37296018, 37296019, 37297941, 37300544, 37300545, 37300546, 37302814, 37308038, 37308039, 37325355, 37328835, 37328836, 37328838, 37331112, 37332012, 37333358, 37333362, 37337364, 37340128, 37340129, 37340130, 37340131, 37340270, 37340271, 37341078, 37341079, 37344296 37344297 37346443 37346445 37348330, 37348331, 37352140, 37352141, 37354943, 37354944, 37357958, 37357959, 37358120, 37359884, 37359885, 37365502, 37365503, 37365504, 37365505, 37375861, 37388591, 37388592, 37388593, 37400608, 37402464, 37402466, 37410374, 37411886, 37411887, 37415923, 37415924, 37415925, 37427250, 37429329, 37429330, 37438134, 37438135, 37439609, 37439610, 37439611, 37451308, 37451309, 37454250, 37454251, 37456595, 37456596, 37459573, 37567407, 37573089, 37573090, 37573091, 37575640, 37578876, 37578877, 37578879, 37579368, 37579369, 37579370, 37582027, 37585524, 37588798, 37588799, 37589260, 37592382, 37592383, 37592384, 37596205, 37596206, 37596207, 37596208, 37601263, 37602176, 37602177, 37602178, 3760… (truncated, 5655 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.

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

Recall #:
98123
Lot/product code:
Lot AZ4824290
Recalling firm:
Tornier, Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

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

Recall #:
98206
Lot/product code:
Material Number: 11549431; UDI-DI: 04056869978741; Serial Numbers: 183047, 183051, 183048, 183050, 183046;
Recalling firm:
Siemens Medical Solutions USA, Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.

Product not cleared by the FDA.

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

Recall #:
98472
Lot/product code:
Model No. SP-C310343-10; No UDI; Lot Code: 01242573.
Recalling firm:
Altruan GmbH
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UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Portex Spinal Tray, Item No. A3729-24 A3595

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

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

Recall #:
98168
Lot/product code:
1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
Recalling firm:
ICU Medical Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled December 18, 2025

Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.

Potential for fraying on the body support strap.

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

Recall #:
98140
Lot/product code:
Model/Catalog Number: K310. ID Codes: K31020120704AA, K31020120706AA, K31020120707AC, K31020120707AD, K31020120707AE, K31020120707AG, K31020120709AA, K31020120709AB, K31020120709AD, K31020120709AE, K31020120710AB, K31020120710AE, K31020120711AB, K31020120712AA, K31020120713AB, K31020120713AC, K31020120713AD, K31020120713AF, K31020120718AA, K31020120718AB, K31020120718AC, K31020120719AC, K31020120720AA, K31020120801AA, K31020120804AB, K31020120804AD, K31020120804AH, K31020120804AI, K31020120806AA, K31020120806AC, K31020120806AD, K31020120806AE, K31020120806AG, K31020120806AH, K31020120806AI, K31020120806AL, K31020120806AM, K31020120806AN, K31020120806AO, K31020120807AA, K31020120807AB, K31020120807AC, K31020120807AE, K31020120807AF, K31020120809AD, K31020120809AE, K31020120810AC, K31020120813AB, K31020120814AA, K31020120814AB, K31020120814AC, K31020120816AA, K31020120816AC, K31020120816AD, K31020120817AB, K31020120817AC, K31020120820AC, K31020120820AD, K31020120821AA, K31020120821AB, K31020120821AC, K31020120821AD, K31020120822AC, K31020120824AA, K31020120824AB, K31020120824AC, K31020120827AC, K31020120828AA, K31020120828AB, K31020120829AA, K31020120830AC, K31020120831AB, K31020120831AC, K31020120831AD, K31020120903AB, K31020120903AC, K31020120904AC, K31020120906AC, K31020120906AD, K31020120906AE, K31020120907AA, K31020120911AA, K31020120911AD, K31020120912AA, K31020120912AB, K31020120912AC, K31020120912AD, K31020120912AG, K31020120914AA, K31020120914AB, K31020120914AC, K31020120914AF, K31020120914AG, K31020120917AA, K31020120917AB, K31020120918AB, K31020120918AD, K31020120918AE, K31020120918AF, K31020120919AB, K31020120919AC, K31020120919AD, K31020120919AE, K31020120921AA, K31020120924AD, K31020120925AA, K31020120925AB, K31020120925AD, K31020120926AB, K31020120926AC, K31020120927AB, K31020121002AA, K31020121002AB, K31020121003AA, K31020121003AB, K31020121003AC, K31020121004AA, K31020121005AB, K31020121005AC, K31020121008AA, K31020121008AB, K31020121008AC, K31020121008AE, K31020121009AC, K31020121009AD, K31020121009AE, K31020121011AA, K31020121011AB, K31020121012AA, K31020121012AB, K31020121013AA, K31020121015AA, K31020121015AB, K31020121017AB, K31020121017AC, K31020121017AD, K31020121017AE, K31020121019AA, K31020121020AA, K31020121022AA, K31020121022AB, K31020121022AC, K31020121023AA, K31020121023AB, K31020121023AC, K31020121024AA, K31020121024AB, K31020121026AA, K31020121026AB, K31020121029AB, K31020121029AC, K31020121029AE, K31020121031AB, K31020121101AA, K31020121104AA, K31020121105AC, K31020121106AA, K31020121106AB, K31020121106AC, K31020121108AA, K31020121108AB, K31020121109AA, K31020121109AB, K31020121109AC, K31020121110AB, K31020121110AE, K31020121113AA, K31020121113AB, K31020121113AC, K31020121113AD, K31020121114AA, K31020121115AA, K31020121115AB, K31020121116AA, K31020121116AB, K31020121116AC, K31020121116AD, K31020121116AE, K31020121117AA, K31020121119AA, K31020121119AB, K31020121119AD, K31020121119AE, K31020121120AA, K31020121120AB, K31020121120AC, K31020121121AA, K31020121121AD, K31020121122AA, K31020121123AA, K31020121123AD, K31020121126AA, K31020121129AC, K31020121129AE, K31020121130AB, K31020121201AA, K31020121201AB, K31020121203AA, K31020121204AA, K31020121205AA, K31020121205AB, K31020121206AA, K31020121206AB, K31020121206AD, K31020121208AA, K31020121208AC, K31020121210AA, K31020121210AB, K31020121210AD, K31020121211AA, K31020121211AB, K31020121212AC, K31020121213AA, K31020121213AB, K31020121213AC, K31020121213AD, K31020121215AB, K31020121217AA, K31020121217AB, K31020121217AC, K31020121217AD, K31020121217AE, K31020121217AF, K31020121218AB, K31020121218AC, K31020121219AC, K31020121220AA, K31020121222AB, K31020121226AA, K31020121228AB, K31020121228AC, K31020121228AD, K31020121231AA, K31020130103AA, K31020130103AB, K31020130105AA, K31020130107AB, K31020130108AA, K31020130108AC, K31020130110AB, K31020130114AD, K31020130114AE, K31020130114AF, K31020130115AA, K31020130116AA, K31020130116AB, K31020130116AD, K31020130117AA, K31020130117AB, K31020130117AC, K31020130117AD, K31020130117AE, K31020130121AA, K31020130121AB, K31020130122AA, K31020130122AB, K31020130122AC, K31020130122AD, K31020130122AE, K31020130122AF, K31020130122AG, K31020130122AH, K31020130123AB, K31020130123AC, K31020130123AD, K31020130124AA, K31020130124AB, K31020130124AC, K31020130128AA, K31020130128AB, K31020130128AC, K31020130129AA, K31020130129AB, K31020130130AC, K31020130130AE, K31020130130AF, K31020130130AG, K31020130131AA, K31020130131AB, K31020130131AD, K31020130201AA, K31020130201AB, K31020130201AD, K31020130201AE, K31020130202AA, K31020130204AB, K31020130205AA, K31020130205AB, K31020130205AC, K31020130205AD, K31020130205AF, K31020130205AG, K31020130205AH, K31020130206AA, K31020130206AB, K31020130206AC, K31020130206AD, K31020130206AE, K31020130206AF, K31020130206AG, K31020130206AI, K31020130208AB, K31020130208AC, K31020130208AD, K31020130208AE, K31020130209AA, K31020130211AB, K31020130211AE, K31020130211AF, K31020130211AG, K3… (truncated, 52213 characters total — see the official FDA record for the full value)
Recalling firm:
Community Products, LLC
View official FDA record (opens in a new tab)