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Recalls affecting Delaware

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

16,355 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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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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.

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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UnclassifiedAnnounced August 31, 2026

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
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

View FDA’s announcement (opens in a new tab)
Wording
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

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

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.

ALL 50 STATES
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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

VANTAGE TITAN 3T Model MRT-3010/MEXL-3010

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.

ALL 50 STATES
▸Full report

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

Recall #:
98112
Lot/product code:
Model Number: MRT-3010/MEXL-3010 UDI-DI code: 04987670101649 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3010/A5 MEXL-3010/A5 A5D14X2031 30000041 MRT-3010/A5 MEXL-3010/A5 A5D13Y2025 30001708 MRT-3010/A5 MEXL-3010/A5 A5D13Y2026 30005894 MRT-3010/A5 MEXL-3010/A5 A5G1692039 30007620 (01)04987670101649(21)A5G1692039 MRT-3010/A5 MEXL-3010/A5.007 A5B11Y2006 30019175 MRT-3010/A7 MEXL-3010/S7 S7A1642006 30024266 (01)04987670101649(21)A7A1642001 MRT-3010/A5 MEXL-3010/A5 A5G1692038 30027318 (01)04987670101649(21)A5G1692038 MRT-3010/A5 MEXL-3010/A5 A5G1642036 30029482 (01)04987670101649(21)A5G1642036 MRT-3010/A5 MEXL-3010/A5.007 A5F1562034 30050314 MRT-3010/A5 MEXL-3010/A5 A5B11Z2007 303354 MRT-3010/A5 MEXL-3010/A5 A5C1252012 336719 MRT-3010/A5 MEXL-3010/A5 A5D1312019 350553 MRT-3010/A5 MEXL-3010/A5 A5B1192003 350579 MRT-3010/A5 MEXL-3010/A5 A5C12X2016 350918 MRT-3010/A5 MEXL-3010/A5 A5C12Y2017 351122 MRT-3010/A5 MEXL-3010/A5 A5C1212009 351387 MRT-3010/A5 MEXL-3010/A5 A5B11Y2005 351452 MRT-3010/A5 MEXL-3010/A5 A5C1262013 356865 MRT-3010/A5 MEXL-3010/A5 A5C1292015 378015 MRT-3010/A5 MEXL-3010/A5 A5C1412028 383946 MRT-3010/A5 MEXL-3010/A5 A5E1522033 389630 MRT-3010/A5 MEXL-3010/A5 A5D1362021 390397
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

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

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.

ALL 50 STATES
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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 18, 2025

Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. 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. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds.

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: K320. ID Codes: K32020130515AA, K32020130603AA, K32020130606AA, K32020130607AB, K32020130610AA, K32020130612AA, K32020130617AA, K32020130617AB, K32020130618AA, K32020130709AA, K32020130713AA, K32020130713AB, K32020130717AB, K32020130802AA, K32020130805AA, K32020130807AA, K32020130808AA, K32020130808AB, K32020130812AA, K32020130812AB, K32020130812AC, K32020130812AD, K32020130813AA, K32020130814AA, K32020130820AA, K32020130822AA, K32020130823AA, K32020130824AA, K32020130827AA, K32020130827AB, K32020130828AA, K32020130830AA, K32020130907AA, K32020130909AB, K32020130909AC, K32020130909AD, K32020130909AE, K32020130919AA, K32020130920AA, K32020130924AA, K32020131007AA, K32020131007AB, K32020131009AA, K32020131017AB, K32020131021AA, K32020131022AB, K32020131022AC, K32020131022AD, K32020131024AA, K32020131025AA, K32020131029AA, K32020131031AA, K32020131101AA, K32020131102AA, K32020131107AA, K32020131115AD, K32020131119AA, K32020131120AD, K32020131205AA, K32020131210AA, K32020131217AD, K32020140103AA, K32020140113AA, K32020140115AA, K32020140117AA, K32020140121AA, K32020140122AA, K32020140122AB, K32020140125AA, K32020140130AB, K32020140210AA, K32020140218AA, K32020140218AB, K32020140220AA, K32020140221AA, K32020140224AA, K32020140304AA, K32020140305AB, K32020140312AA, K32020140315AA, K32020140327AA, K32020140327AC, K32020140401AA, K32020140407AA, K32020140407AB, K32020140408AA, K32020140412AA, K32020140415AA, K32020140417AA, K32020140422AA, K32020140423AA, K32020140426AA, K32020140429AA, K32020140514AB, K32020140516AA, K32020140516AB, K32020140519AA, K32020140519AB, K32020140520AA, K32020140520AB, K32020140523AA, K32020140528AA, K32020140528AB, K32020140530AA, K32020140530AB, K32020140530AC, K32020140604AA, K32020140607AA, K32020140619AA, K32020140619AB, K32020140620AB, K32020140624AB, K32020140626AA, K32020140711AB, K32020140712AA, K32020140719AA, K32020140721AA, K32020140722AA, K32020140722AB, K32020140725AA, K32020140728AA, K32020140730AC, K32020140802AA, K32020140805AA, K32020140812AA, K32020140812AB, K32020140815AA, K32020140827AA, K32020140902AA, K32020140906AA, K32020140913AB, K32020140915AB, K32020140917AA, K32020140918AA, K32020140923AA, K32020140923AB, K32020140924AA, K32020140929AA, K32020140930AA, K32020141006AA, K32020141006AB, K32020141006AC, K32020141008AA, K32020141014AA, K32020141021AA, K32020141028AA, K32020141030AA, K32020141031AA, K32020141101AB, K32020141107AA, K32020141107AB, K32020141113AA, K32020141113AB, K32020141118AD, K32020141120AA, K32020141121AA, K32020141121AB, K32020141124AA, K32020141128AA, K32020141203AA, K32020141209AA, K32020141209AC, K32020141213AA, K32020141215AA, K32020141215AB, K32020141215AC, K32020141215AD, K32020141229AA, K32020141229AB, K32020141229AC, K32020150102AA, K32020150112AA, K32020150123AA, K32020150128AA, K32020150128AB, K32020150128AC, K32020150129AA, K32020150130AA, K32020150130AB, K32020150130AC, K32020150202AA, K32020150203AA, K32020150207AB, K32020150207AC, K32020150211AA, K32020150211AC, K32020150221AA, K32020150226AB, K32020150227AA, K32020150302AA, K32020150303AA, K32020150304AA, K32020150304AB, K32020150309AA, K32020150312AA, K32020150312AB, K32020150319AA, K32020150323AA, K32020150323AB, K32020150325AA, K32020150325AB, K32020150330AA, K32020150331AA, K32020150331AB, K32020150331AC, K32020150331AD, K32020150415AA, K32020150415AB, K32020150415AC, K32020150415AD, K32020150416AA, K32020150416AB, K32020150417AA, K32020150418AB, K32020150421AA, K32020150421AB, K32020150421AC, K32020150421AD, K32020150423AA, K32020150427AB, K32020150430AA, K32020150430AB, K32020150506AA, K32020150506AC, K32020150508AA, K32020150518AB, K32020150519AA, K32020150519AB, K32020150519AC, K32020150521AA, K32020150601AA, K32020150602AA, K32020150602AB, K32020150609AA, K32020150609AB, K32020150609AC, K32020150610AA, K32020150612AA, K32020150615AA, K32020150619AB, K32020150620AA, K32020150622AA, K32020150622AB, K32020150626AB, K32020150629AB, K32020150701AA, K32020150704AA, K32020150709AA, K32020150710AA, K32020150711AA, K32020150714AA, K32020150715AA, K32020150717AA, K32020150720AA, K32020150721AA, K32020150723AA, K32020150724AB, K32020150727AA, K32020150801AA, K32020150803AA, K32020150805AB, K32020150806AA, K32020150807AA, K32020150811AB, K32020150818AA, K32020150818AB, K32020150818AC, K32020150819AA, K32020150819AC, K32020150822AA, K32020150824AA, K32020150824AB, K32020150825AA, K32020150826AA, K32020150831AA, K32020150901AA, K32020150901AC, K32020150901AD, K32020150909AA, K32020150911AA, K32020150915AA, K32020150915AB, K32020150922AA, K32020150922AB, K32020150922AC, K32020150922AD, K32020150925AA, K32020150925AB, K32020151001AA, K32020151003AB, K32020151003AC, K32020151009AA, K32020151010AA, K32020151012AA, K32020151012AC, K32020151023AA, K32020151027AA, K32020151027AB, K32020151031AA, K32020151102AA, K32020151102AB, K32020151104AA, K32020151107AA, K32020151109AA, K32020151112AA, K32020151112AB, K32020151116AA, K32020151120AA, K32020151123AA, K32020151124AA, K3… (truncated, 17749 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)
UnclassifiedRisk not yet known
Medical deviceRecalled December 18, 2025

Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E. Gelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E,

Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.

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▸Full report

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

Recall #:
98338
Lot/product code:
All Gelsoft Plus devices (any item number ending 'E-B' e.g. 631206PE-B); REF, Item Number, UDI-DI(GTIN): 635024PE, 635024PE-B, 5037881166636; 631514PE, 631514PE-B, 5037881166858; 631222PE, 631222PE-B, 5037881166896; 633008PE, 633008PE-B, 5037881166698; 633010PE, 633010PE-B, 5037881166711; 633007PE, 633007PE-B, 5037881166681; 636010PE, 636010PE-B, 5037881166520; 632522PE, 632522PE-B, 5037881166780; 633012PE, 633012PE-B, 5037881166728; 635018PE, 635018PE-B, 5037881166605; 631516PE, 631516PE-B, 5037881166865; 636016PE, 636016PE-B, 5037881166551; 631220PE, 631220PE-B, 5037881166889; 631608PE, 631608PE-B, 5037881166933; 631206PE, 631206PE-B, 5037881166919; 631407P50E, 631407P50E-B, 5037881167008; 631508PE, 631508PE-B, 5037881166827; 636008PE, 636008PE-B, 5037881166513; 636006PE, 636006PE-B, 5037881166063; 632518PE, 632518PE-B, 5037881166759; 634008PE, 634008PE-B, 5037881166667; 634006PE, 634006PE-B, 5037881166643; 631218PE, 631218PE-B, 5037881166872; 632211PE, 632211PE-B, 5037881166971; 634007PE, 634007PE-B, 5037881166650; 633006PE, 633006PE-B, 5037881166674; 631506PE, 631506PE-B, 5037881166803; 632524PE, 632524PE-B, 5037881166797; 636007PE, 636007PE-B, 5037881166506; 631512PE,631512PE-B, 5037881166841; 636012PE, 636012PE-B, 5037881166537; 636014PE, 636014PE-B, 5037881166544; 632211P50E, 632211P50E-B, 5037881167046; 633016PE, 633016PE-B, 5037881166742; 631407PE, 631407PE-B, 5037881166926; 631809PE, 631809PE-B, 5037881166940; 632010PE, 632010PE-B, 5037881166964; 631608P50E, 631608P50E-B, 5037881167015; 632520PE, 632520PE-B, 5037881166773; 632412PE, 632412PE-B, 5037881166988; 631510PE, 631510PE-B, 5037881166834; 635022PE, 635022PE-B, 5037881166629; 631224PE, 631224PE-B, 5037881166902; 632412P50E, 632412P50E-B, 5037881167053; 631507PE, 631507PE-B, 5037881166810; 633014PE, 633014PE-B, 5037881166735; 632010P50E, 632010P50E-B, 5037881167039; 635020PE, 635020PE-B, 5037881166612; 631809P50E, 631809P50E-B, 5037881167022. All Gelweave devices (any item number ending E-B e.g. 7320128/10RMEE-B); REF, Item Number, UDI-DI(GTIN): 736038E, 736038E-B, 5037881169415; 736036E, 736036E-B, 5037881169408; 736034E, 736034E-B, 5037881169392; 736032ST/10DE, 736032ST/10DE-B, 5037881172620; 736032E, 736032E-B, 5037881169385; 736030ST/10DE, 736030ST/10DE-B, 5037881172637; 736030E , 736030E-B, 5037881169378; 736028ST/10DE, 736028ST/10DE-B, 5037881172644; 736028E, 736028E-B, 5037881169361; 736026ST/10DE, 736026ST/10DE-B, 5037881172651; 736026E, 736026E-B, 5037881169354; 736024ST/10DE, 736024ST/10DE-B, 5037881172668; 736024E, 736024E-B, 5037881169347; 736022ST/10DE, 736022ST/10DE-B, 5037881172675; 736022E, 736022E-B, 5037881169330; 736020E, 736020E-B, 5037881169323; 736018E, 736018E-B, 5037881169316; 736016E, 736016E-B, 5037881114057; 736014E, 736014E-B, 5037881114040; 736012E, 736012E-B, 5037881168548; 736010E, 736010E-B, 5037881168517; 736008E, 736008E-B, 5037881168494; 736006E, 736006E-B, 5037881166056; 735034ST/8AE, 735034ST/8AE-B, 5037881173061; 735034/8RME, 735034/8RME-B, 5037881170039; 735034/10SEE, 735034/10SEE-B, 5037881171883; 735034/10RME, 735034/10RME-B, 5037881169958; 735032STE, 735032STE-B, 5037881175102; 735032ST/8AE, 735032ST/8AE-B, 5037881173078; 735032/8SE, 735032/8SE-B, 5037881172095; 735032/8RME, 735032/8RME-B, 5037881170046; 735032/10SEE, 735032/10SEE-B, 5037881171890; 735032/10RME, 735032/10RME-B, 5037881169965; 735030STE, 735030STE-B, 5037881175126; 735030ST/8AE, 735030ST/8AE-B, 5037881173085; 735030/8SE, 735030/8SE-B, 5037881172101; 735030/8RME, 735030/8RME-B, 5037881170053; 735030/10SEE, 735030/10SEE-B, 5037881171906; 735030/10RME, 735030/10RME-B, 5037881169972; 735028STE, 735028STE-B, 5037881175133; 735028ST/8AE, 735028ST/8AE-B, 5037881173092; 735028E, 735028E-B 5037881168876; 735028/8SE, 735028/8SE-B, 5037881172118; 735028/8RME, 735028/8RME-B, 5037881170060; 735028/10RME, 735028/10RME-B, 5037881169989; 735026STE, 735026STE-B, 5037881175140; 735026ST/8AE, 735026ST/8AE-B, 5037881173108; 735026E, 735026E-B, 5037881168869; 735026/8SE, 735026/8SE-B, 5037881172125; 735026/8RME, 735026/8RME-B, 5037881170077; 735026/10RME, 735026/10RME-B, 5037881169996; 735024STE, 735024STE-B, 5037881175164; 735024ST/8AE, 735024ST/8AE-B, 5037881173115; 735024E, 735024E-B, 5037881168845; 735024/8SE, 735024/8SE-B, 5037881172132; 735024/8RME, 735024/8RME-B, 5037881170084; 735024/10SEE, 735024/10SEE-B, 5037881171937; 735024/10RME, 735024/10RME-B, 5037881170008; 735022STE, 735022STE-B, 5037881175188; 735022E, 735022E-B, 5037881168838; 735022/8SE, 735022/8SE-B, 5037881172149; 735022/8RME, 735022/8RME-B, 5037881170091; 735020E, 735020E-B, 5037881168821; 735020/8RME, 735020/8RME-B, 5037881170107; 735018E, 735018E-B, 5037881168814; 734038E, 734038E-B, 5037881169309; 734036E, 734036E-B, 5037881169293; 734034E, 734034E-B, 5037881169286; 734034CX4RMSE, 734034CX4RMSE-B, 5037881170794; 734034/8E, 734034/8E-B, 5037881172460; 734034/10E, 734034/10E-B, 5037881172224; 734032E, 734032E-B, 5037881169279; 734032CX4RMSE, 734032CX4RMSE-B, 5037881170800; 734032… (truncated, 14600 characters total — see the official FDA record for the full value)
Recalling firm:
Vascutek, Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 18, 2025

Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion.

Potential for fraying on the body support strap.

ALL 50 STATES
▸Full report

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

Recall #:
98140
Lot/product code:
Model/Catalog Number: K660. ID Codes: K66020170425AA, K66020170612AA, K66020170621AA, K66020170622AA, K66020170626AA, K66020170626AB, K66020170626AC, K66020170627AC, K66020170627AD, K66020170628AA, K66020170629AA, K66020170703AA, K66020170705AA, K66020170711AA, K66020170712AA, K66020170712AC, K66020170713AB, K66020170716AA, K66020170717AA, K66020170717AB, K66020170804AA, K66020170805AA, K66020170807AA, K66020170810AA, K66020170810AB, K66020170811AA, K66020170811AC, K66020170815AA, K66020170817AC, K66020170818AC, K66020170831AA, K66020170831AB, K66020170906AA, K66020170906AB, K66020170911AA, K66020170911AB, K66020170911AC, K66020170913AA, K66020170914AA, K66020170915AA, K66020170921AA, K66020170923AA, K66020170926AA, K66020170927AA, K66020170928AA, K66020171004AA, K66020171006AA, K66020171006AB, K66020171007AA, K66020171010AA, K66020171010AB, K66020171019AA, K66020171020AA, K66020171024AA, K66020171026AA, K66020171026AB, K66020171026AC, K66020171028AA, K66020171030AA, K66020171101AA, K66020171101AB, K66020171103AC, K66020171107AA, K66020171107AB, K66020171116AA, K66020171121AA, K66020171127AA, K66020171128AA, K66020171128AB, K66020171206AA, K66020171207AA, K66020171214AA, K66020171216AA, K66020171219AA, K66020171227AA, K66020171227AC, K66020180102AA, K66020180104AA, K66020180109AA, K66020180109AB, K66020180113AA, K66020180113AB, K66020180117AA, K66020180118AA, K66020180120AA, K66020180124AA, K66020180126AA, K66020180130AA, K66020180130AB, K66020180131AA, K66020180131AC, K66020180203AA, K66020180206AA, K66020180206AB, K66020180208AB, K66020180209AA, K66020180213AA, K66020180216AA, K66020180220AA, K66020180220AB, K66020180220AC, K66020180221AA, K66020180226AA, K66020180227AA, K66020180227AB, K66020180306AA, K66020180309AA, K66020180312AA, K66020180322AA, K66020180326AB, K66020180403AA, K66020180405AA, K66020190306AA, K66020190306AB, K66020190322AA, K66020190325AA, K66020190325AB, K66020190401AA, K66020190401AB, K66020190401AC, K66020190402AA, K66020190406AA, K66020190406AB, K66020190408AA, K66020190408AB, K66020190410AA, K66020190415AA, K66020190416AA, K66020190416AB, K66020190417AA, K66020190418AA, K66020190418AB, K66020190418AC, K66020190422AA, K66020190423AA, K66020190424AA, K66020190429AA, K66020190501AA, K66020190501AB, K66020190501AC, K66020190501AD, K66020190501AE, K66020190502AA, K66020190508AA, K66020190508AB, K66020190509AA, K66020190514AA, K66020190520AB, K66020190520AD, K66020190521AB, K66020190522AA, K66020190523AB, K66020190527AA, K66020190528AA, K66020190528AB, K66020190528AC, K66020190604AA, K66020190605AA, K66020190606AB, K66020190611AA, K66020190612AA, K66020190614AA, K66020190617AB, K66020190617AC, K66020190618AA, K66020190618AB, K66020190618AC, K66020190620AA, K66020190624AA, K66020190624AB, K66020190625AA, K66020190702AA, K66020190705AA, K66020190705AB, K66020190708AA, K66020190709AA, K66020190709AB, K66020190710AA, K66020190710AB, K66020190716AA, K66020190717AA, K66020190722AB, K66020190722AC, K66020190724AB, K66020190726AA, K66020190730AA, K66020190731AA, K66020190801AA, K66020190806AA, K66020190806AB, K66020190806AC, K66020190812AA, K66020190814AA, K66020190815AA, K66020190815AB, K66020190819AA, K66020190820AA, K66020190822AA, K66020190822AB, K66020190822AC, K66020190824AA, K66020190830AA, K66020190831AA, K66020190904AA, K66020190906AA, K66020190913AA, K66020190916AA, K66020190919AA, K66020190919AB, K66020190919AC, K66020190926AA, K66020190930AD, K66020191001AA, K66020191001AB, K66020191003AA, K66020191003AC, K66020191003AD, K66020191005AA, K66020191005AB, K66020191005AC, K66020191007AA, K66020191008AA, K66020191009AA, K66020191015AA, K66020191016AA, K66020191017AA, K66020191018AA, K66020191022AA, K66020191025AB, K66020191025AC, K66020191025AD, K66020191029AA, K66020191030AB, K66020191114AA, K66020191119AA, K66020191121AA, K66020191122AA, K66020191126AA, K66020191126AB, K66020191128AA, K66020191205AA, K66020191206AA, K66020191206AC, K66020191207AA, K66020191210AA, K66020191217AA, K66020191217AB, K66020191220AA, K66020191224AA, K66020191224AB, K66020191227AA, K66020191228AA, K66020200103AA, K66020200103AB, K66020200107AA, K66020200116AA, K66020200116AB, K66020200120AA, K66020200120AB, K66020200121AA, K66020200121AB, K66020200122AA, K66020200127AA, K66020200127AB, K66020200127AC, K66020200129AA, K66020200129AB, K66020200129AC, K66020200131AA, K66020200204AA, K66020200205AA, K66020200207AA, K66020200210AA, K66020200210AB, K66020200211AA, K66020200212AA, K66020200212AB, K66020200213AA, K66020200214AA, K66020200215AA, K66020200217AA, K66020200217AB, K66020200220AA, K66020200227AA, K66020200229AA, K66020200302AA, K66020200302AB, K66020200303AA, K66020200304AA, K66020200304AB, K66020200309AA, K66020200309AB, K66020200310AA, K66020200312AA, K66020200320AC, K66020200320AD, K66020200325AA, K66020200326AA, K66020200328AA, K66020200403AA, K66020200428AA, K66020200430AA, K66020200505AA, K66020200505AB, K66020200505AC, K66020200505AD, K66020200508AA, K66020200514AA, K66020200520AA, K66020200521AA, K6… (truncated, 7685 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)
Class IIModerate risk
DrugRecalled December 18, 2025

Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.

Presence of particulate matter - Glass like particles.

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

Recall #:
D-0250-2026
Lot/product code:
Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.
Recalling firm:
Imprimis NJOF, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 18, 2025

Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.

Presence of particulate matter - Glass like particles.

ALL 50 STATES
▸Full report

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

Recall #:
D-0251-2026
Lot/product code:
Lot: 25JAN033A, 25JAN033B, Expires: 02/12/2026.
Recalling firm:
Imprimis NJOF, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 18, 2025

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

Presence of particulate matter - Glass like particles.

ALL 50 STATES
▸Full report

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

Recall #:
D-0249-2026
Lot/product code:
Lot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026
Recalling firm:
Imprimis NJOF, LLC
View official FDA record (opens in a new tab)
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.

ALL 50 STATES
▸Full report

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)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Genesis Screw-In Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

ALL 50 STATES
▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 10B45003, 10B55003, 10B65003; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

AlternatiV+ Max Knotless Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

ALL 50 STATES
▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 20KPN4751, 20KPN5501; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Genesis Dual Thread Screw-In Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

ALL 50 STATES
▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 10N47502, 10N55002; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

AlternatiV+ Screw-In Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

ALL 50 STATES
▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 20BN4753, 20BN5503; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Genesis Knotless Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

ALL 50 STATES
▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 10KPN4751, 10KPN5501; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Fixone Biocomposite Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

ALL 50 STATES
▸Full report

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

Recall #:
98312
Lot/product code:
Model No. BAB-55003ch, BAN-55003b, SAB-30002e; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Fixone Hybrid Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

ALL 50 STATES
▸Full report

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

Recall #:
98312
Lot/product code:
Model No. KAPN-47501nc, KAPN-55001c, KAPN-55001na, KAPN-55001nc; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2025

BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29

Lack of Assurance of Sterlity

ALL 50 STATES
▸Full report

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

Recall #:
D-0243-2026
Lot/product code:
Lot #: 5086623, Exp. Date 03/31/2028
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Genesis Push-In Suture Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

ALL 50 STATES
▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 10S30002; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
1. 25GA Convenience Kit - FNX Pouch UDI 810123482917 Box UDI 810123482924 Lot 2410055 2. 25GA Convenience Kit - FXX Pouch UDI 810123482429 Box UDI 810123482443 Lot 2411028 3. 25GA Convenience Kit - XES Pouch UDI 810123482412 Box UDI 810123482436 Lot 2410057
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
1. 23G Laser Probe OS4 Flex-Tip Pouch UDI 810123483716 Box UDI 810123483792 Lot 2410031 2. 23G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483730 Box UDI 810123483815 Lot 2410034 3. 23G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483761 Box UDI 810123483846 Lot 2410033 4. 25G Laser Probe OS4 Flex-Tip Pouch UDI 810123483723 Box UDI 810123483808 Lot 2410032 2410058 2411022; 5. 25G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483747 Box UDI 810123483822 Lot 2410035 6. 25G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483778 Box UDI 810123483853 Lot 2412025 7. 27G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483785 Box UDI 810123483860 Lot 2411021
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

ALL 50 STATES
▸Full report

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

Recall #:
98197
Lot/product code:
REF CDS980754T: UDI/DI 10198459121814 (EA) 40198459121815 (CS), Lot Number 25EMD795; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBR237; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBP591; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25DBM353; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25CBL184; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25BBL633; REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25FBK918; REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25CBJ496; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25FBF371; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25EBK493; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25DBH895; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25DBC272; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBU642; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBJ298; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25BBU206; REF DYNJ901281I: UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25FBA261; REF DYNJ901281I: UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25CBN230; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25FDB398; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25DDA191; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25BDB095; REF DYNJ902030J: UDI/DI 10195327391249 (EA) 40195327391240 (CS), Lot Number 25DBJ371; REF DYNJ905274D: UDI/DI 10195327393014 (EA) 40195327393015 (CS), Lot Number 25BBS130; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25FBJ689; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25EBP700; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25DBG283; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBJ430; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBC561; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBK650; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBE453; REF DYNJ910634: UDI/DI 10198459050398 (EA) 40198459050399 (CS), Lot Number 25CBS527; REF DYNJ910927: UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25FMC511; REF DYNJ910927: UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25CMJ281.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)