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Recalls affecting Kansas

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

16,768 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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UnclassifiedAnnounced August 31, 2026

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

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

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

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

*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

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.

ALL 50 STATES
▸Full report

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

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.

ALL 50 STATES
▸Full report

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

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.

ALL 50 STATES
▸Full report

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

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

Product not cleared by the FDA.

ALL 50 STATES
▸Full report

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

*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
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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

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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▸Full report

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

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

ALL 50 STATES
▸Full report

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

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

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

ALL 50 STATES
▸Full report

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: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE

Due to products not having FDA Premarket authorization to be distributed within the United States.

CACOFLGAILKSMDMIMOTNTXWAWI
▸Full report

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

Recall #:
98220
Lot/product code:
Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361
Recalling firm:
MicroPort Orthopedics Inc.
View official FDA record (opens in a new tab)
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.

ALL 50 STATES
▸Full report

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
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)
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.

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-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

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)
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)
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.

ALL 50 STATES
▸Full report

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

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)
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)