BIGNOPE
Ko-fi

Recalls affecting Delaware

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

16,355 recalls found
NewOld
High RiskLow Risk
AllClear

Just announced

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

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

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

ALL 50 STATES
▸Full report

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

Recall #:
98277
Lot/product code:
UDI-DI (case) 20197344019554¿ (ea) 10197344019557 Lots EP250324 EP250416 EP250512 EP250521 EP250609 EP250630 EP250710 EP250724
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

ALL 50 STATES
▸Full report

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

Recall #:
98277
Lot/product code:
401582RH UDI-DI (case) 20888277407517¿ (ea) 10888277407510 Lots EP250618 EP250630; 401940RH UDI-DI 10888277407480 Lot EP250618; 401904RH UDI-DI (case) 20888277407609¿ (ea) 10888277407602 Lots EP250618 EP250630; 401914RH UDI-DI (case) 20888277407524¿ (ea) 10888277407527 Lot EP250618; 401932RH UDI-DI (case) 20888277407678¿ (ea) 10888277407671 Lots EP250618 EP250630; 401652RH UDI-DI 10888277407572 Lots EP250618 EP250630
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

ALL 50 STATES
▸Full report

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

Recall #:
98277
Lot/product code:
401211RH UDI-DI 10197344043736 Lot EP250317; 401222RH UDI-DI 10197344043712 Lot EP250317; 401223RH UDI-DI 10197344043705 Lot EP250317; 401226RH UDI-DI 10197344043699 Lot EP250307 EP250317; 401227RH UDI-DI 10197344043682 Lots EP250307 EP250317; 401260RH UDI-DI 10197344043668 Lot EP250317; 401261RH UDI-DI 10197344043651 Lot EP250317; 401306RH UDI-DI 10197344043620¿ Lot EP250317; 401309RH UDI-DI 10197344043613 Lot EP250317; 401312RH UDI-DI 10197344043583¿ Lot EP250307; 401430RH UDI-DI 10197344043491 Lots EP250307 EP250317; 401433RH UDI-DI 10197344043484 Lots EP250307 EP250317; 401435RH UDI-DI 10197344043460 Lots EP250307 EP250317; 401441RH UDI-DI 10197344043439 Lots EP250307 EP250317; 401442RH UDI-DI 10197344044245 Lot EP250307; 401443RH UDI-DI 10197344044252 Lots EP250307 EP250317; 401448RH UDI-DI 10197344044283 Lot EP250307; 401449RH UDI-DI 10197344044290 Lot EP250307; 401450RH UDI-DI 10197344044306 Lots EP250307 EP250317; 401451RH UDI-DI 10197344044313 EP250307 EP250317; 401474RH UDI-DI 10197344044351 Lot EP250307; 401860RH UDI-DI 10197344044382 Lots EP250307 EP250317; 401877RH UDI-DI 10197344044436 Lots EP250307 EP250317; 401878RH UDI-DI 10197344044443 Lot EP250307; 401890RH UDI-DI 10197344044450 Lots EP250307 EP250317; 401891RH UDI-DI 10197344044467 Lot EP250307; 401994RH UDI-DI 10197344044542 Lot EP250317; 402012RH UDI-DI 10197344043835 Lots EP250307 EP250317; 402004RH UDI-DI 10197344044566 Lots EP250307 EP250317; 402010RH UDI-DI 10197344044597 Lots EP250307 EP250317; 402008RH UDI-DI 10197344044573 Lot EP250317; 402009RH UDI-DI 10197344044580 Lots EP250307 EP250317 ***Updated 5/18/26*** LOT EP250203 added to the scope of action for the following SKUs 401222RH 401223RH 401226RH 401227RH 401261RH 401430RH 401433RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401860RH 401891RH 402004RH 402010RH 402012RH
Recalling firm:
Medline Industries, LP
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
▸Full report

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

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.

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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.

ALL 50 STATES
▸Full report

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

Recall #:
98237
Lot/product code:
Material Number (UPN): M00553680; UDI-DI: 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

*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

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

ALL 50 STATES
▸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

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

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.

ALL 50 STATES
▸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

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

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

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. 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

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

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

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-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

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

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

ALL 50 STATES
▸Full report

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

Recall #:
98206
Lot/product code:
Material Number: 11549431; UDI-DI: 04056869978741; Serial Numbers: 183047, 183051, 183048, 183050, 183046;
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

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

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

ALL 50 STATES
▸Full report

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

Recall #:
98123
Lot/product code:
Lot AZ4824290
Recalling firm:
Tornier, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

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

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

ALL 50 STATES
▸Full report

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

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

Portex Spinal Tray, Item No. A3729-24 A3595

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

ALL 50 STATES
▸Full report

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

Recall #:
98168
Lot/product code:
1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
Recalling firm:
ICU Medical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

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

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

ALL 50 STATES
▸Full report

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

Recall #:
98237
Lot/product code:
Material Number (UPN): M00553680; UDI-DI: 8714729951179; Lot Numbers: 35961006 35961007 35962524 35967379 35968520, 35968521, 35968597, 35968598, 35971077, 35971078, 35971079, 35972100, 35982272, 35982273, 35982274, 35982275, 35982276, 35982277, 35982278, 35982279, 35982420, 35982424, 35982425, 35985313, 35985314, 35993619, 35993720, 35993721, 36109761, 36109763, 36109764, 36109765, 36109766, 36111314, 36111315, 36118993, 36118994, 36122066, 36122067, 36122075, 36132801, 36132802, 36132803, 36132804, 36134972, 36144058, 36144059, 36144120, 36144121, 36174475, 36174476, 36178005, 36187588, 36187589, 36187687, 36187688, 36188887, 36188888, 36188889, 36194446, 36194447, 36197239, 36198580, 36217768, 36217769, 36217770, 36227341, 36227342, 36227343, 36228603, 36228604, 36228605, 36235934, 36236151, 36240589, 36240590, 36241715, 36241716, 36241717, 36251363, 36251364, 36253000, 36253008, 36253041, 36260860, 36260861, 36260862, 36261599, 36261780, 36261781, 36261834, 36261835, 36280395, 36280396, 36280397, 36281912, 36281913, 36281914, 36283860, 36292682, 36292683, 36292684, 36292689, 36292690, 36292691, 36294495, 36301621, 36301622, 36301623, 36301624, 36302290, 36302291, 36302292, 36319024, 36319025, 36319026, 36320016, 36320017, 36323789, 36323790, 36324720, 36325159, 36325560, 36325568, 36325569, 36332101, 36332102, 36341577, 36342114, 36342418, 36352008, 36352009, 36355049, 36355050, 36355752, 36359567, 36362263, 36362264, 36362265, 36363150 36363151 36364647 36372361 36372362, 36377757, 36378548, 36380549, 36388531, 36390612, 36396985, 36399492, 36403441, 36408983, 36408984, 36417820, 36417821, 36418721, 36418722, 36424650, 36424651, 36424652, 36425889, 36425890, 36425891, 36425892, 36462323, 36462324, 36469427, 36469428, 36469812, 36472250, 36472253, 36472254, 36475370, 36478478, 36478479, 36572740, 36572741, 36573582, 36573583, 36573587, 36573588, 36573589, 36573590, 36591073, 36591074, 36591075, 36603384, 36603385, 36603386, 36604188, 36604189, 36604190, 36604191, 36604748, 36604749, 36607249, 36607250, 36607251, 36607252, 36607253, 36610818, 36610819, 36611060, 36615703, 36615704, 36621589, 36621590, 36623324, 36623325, 36623326, 36693849, 36693850, 36693851, 36693852, 36694699, 36695020, 36695021, 36695023, 36698247, 36698249, 36698251, 36698527, 36698528, 36698529, 36698530, 36698531, 36698532, 36706712, 36706713, 36706714, 36706715, 36709766, 36709767, 36709768, 36709769, 36713255, 36713256, 36713257, 36713258, 36717717, 36717718, 36717719, 36717800, 36717801, 36717802, 36718966, 36718967, 36723909, 36723910, 36728154, 36764237, 36764238, 36767449, 36767450, 36771884, 36771885, 36771886, 36785593, 36788793, 36788794, 36788795, 36795369, 36795370, 36796430, 36796431, 36804013, 36804375, 36839665, 36895362, 36895363, 36895364, 36958216, 36958217, 36962750, 36970218, 36970219, 36980309, 36980310 36981855 36981856 36982694 36983909, 36985933, 36988630, 36988631, 36988632, 36990382, 36990383, 36991168, 36991170, 36991683, 36992721, 37014102, 37014103, 37014104, 37027339, 37028180, 37028181, 37030756, 37032104, 37036344, 37036345, 37037505, 37037506, 37040169, 37041012, 37041435, 37041436, 37046449, 37046450, 37046928, 37046929, 37048665, 37049464, 37049465, 37049874, 37050321, 37050322, 37050323, 37055465, 37055466, 37055467, 37056013, 37056014, 37057032, 37059006, 37059010, 37094844, 37106164, 37106583, 37131143, 37131144, 37131145, 37131146, 37177253, 37177271, 37177272, 37179955, 37179956, 37180902, 37180903, 37182323, 37183490, 37188257, 37188258, 37197563, 37197578, 37198908, 37199019, 37199360, 37199361, 37199972, 37199973, 37209169, 37209170, 37209171, 37211282, 37211285, 37212243, 37212244, 37212245, 37212246, 37213246, 37213247, 37213248, 37213249, 37240012, 37240013, 37240236, 37240237, 37240249, 37240250, 37240252, 37240254, 37242247, 37242248, 37242249, 37243754, 37243755, 37243756, 37247304, 37247305, 37247306, 37283604, 37283605, 37291851, 37291852, 37292951, 37292952, 37296017, 37296018, 37296019, 37297941, 37300544, 37300545, 37300546, 37302814, 37308038, 37308039, 37325355, 37328835, 37328836, 37328838, 37331112, 37332012, 37333358, 37333362, 37337364, 37340128, 37340129, 37340130, 37340131, 37340270, 37340271, 37341078, 37341079, 37344296 37344297 37346443 37346445 37348330, 37348331, 37352140, 37352141, 37354943, 37354944, 37357958, 37357959, 37358120, 37359884, 37359885, 37365502, 37365503, 37365504, 37365505, 37375861, 37388591, 37388592, 37388593, 37400608, 37402464, 37402466, 37410374, 37411886, 37411887, 37415923, 37415924, 37415925, 37427250, 37429329, 37429330, 37438134, 37438135, 37439609, 37439610, 37439611, 37451308, 37451309, 37454250, 37454251, 37456595, 37456596, 37459573, 37567407, 37573089, 37573090, 37573091, 37575640, 37578876, 37578877, 37578879, 37579368, 37579369, 37579370, 37582027, 37585524, 37588798, 37588799, 37589260, 37592382, 37592383, 37592384, 37596205, 37596206, 37596207, 37596208, 37601263, 37602176, 37602177, 37602178, 3760… (truncated, 5655 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
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

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.

ALL 50 STATES
▸Full report

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)