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Recalls affecting New Mexico

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

16,391 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary 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 AliveMoringa 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. Braun0.9% 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 ValueOrganic 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 TemptationsChocolatey 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

LipofitLipofit 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

KofinasGarlic 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 SproutsRobust 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

MartinaMangoes

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 4, 2025

Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201

Inflation device handle may detach from the syringe during procedure.

ALL 50 STATES
Full report

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

Recall #:
98139
Lot/product code:
Reference Number/UDI/Lot Number: K05-00761F: 00884450294918 H2801768 00884450294918 H2872045 K05-01717B: 00884450139325 H2613573 00884450139325 H2650871 00884450139325 H2697189 00884450139325 H2736533 00884450139325 H2767978 00884450139325 H2787955 00884450139325 H2823896 00884450139325 H2844892 00884450139325 H2849102 00884450139325 H2854783 00884450139325 H2864807 00884450139325 H2869821 00884450139325 H2911094 00884450139325 H2920493 00884450139325 H2937574 00884450139325 H2980776 00884450139325 H3006229 00884450139325 H3030118 00884450139325 H3041746 00884450139325 H3068295 00884450139325 H3077898 00884450139325 H3096168 00884450139325 H3115553 00884450139325 H3125118 00884450139325 H3136596 00884450139325 H3147935 00884450139325 H3179116 00884450139325 H3191157 00884450139325 H3215391 00884450139325 H3227692 00884450139325 H3266089 00884450139325 H3324827 K05-02080D: 00884450141663 H3248072 K05-02090C: 00884450141687 H3079962 K05-02221: 00884450141878 H2867356 00884450141878 H3183526 K05-02338: 00884450139950 H2994406 K05-02470: 00884450140406 H3183534 K05-02954: 00884450298350 H2725969 K05-03094A: 00884450756102 I2725535 00884450756102 I3254468 K05T-00380C: 00884450286999 T2636525 00884450286999 T2697344 00884450286999 T2730359 00884450286999 T2745227 00884450286999 T2779731 00884450286999 T2792255 00884450286999 T2805457 00884450286999 T2842259 00884450286999 T2865498 00884450286999 T2916415 00884450286999 T2981465 00884450286999 T2985902 00884450286999 T3039943 00884450286999 T3054879 00884450286999 T3071602 00884450286999 T3105835 00884450286999 T3128753 00884450286999 T3185484 00884450286999 T3223241 00884450286999 T3229633 00884450286999 T3276968 00884450286999 T3328128 00884450286999 T3356293 K05T-01674B: 00884450140796 T2774647 00884450140796 T2800974 00884450140796 T2823388 00884450140796 T2853488 00884450140796 T2899143 00884450140796 T2981467 00884450140796 T2987762 00884450140796 T3022097 00884450140796 T3022100 00884450140796 T3058385 00884450140796 T3083003 00884450140796 T3121582 00884450140796 T3174127 00884450140796 T3214493 00884450140796 T3229456 00884450140796 T3297510 00884450140796 T3324542 K05T-01863: 00884450315347 T2625813 00884450315347 T2718633 00884450315347 T2762715 00884450315347 T2805459 00884450315347 T2823390 00884450315347 T2863782 00884450315347 T2910718 00884450315347 T2981470 00884450315347 T2997667 00884450315347 T3036044 00884450315347 T3070773 00884450315347 T3108821 00884450315347 T3149886S 00884450315347 T3185539 00884450315347 T3214494 00884450315347 T3216705 00884450315347 T3276914 00884450315347 T3296092 00884450315347 T3328139 K05T-01915: 00884450142882 T2643556 00884450142882 T2675575 00884450142882 T2752946 00884450142882 T2842262 00884450142882 T2893876 00884450142882 T2906056 00884450142882 T2981474 00884450142882 T2987764 00884450142882 T3070812 00884450142882 T3146178 00884450142882 T3216084 00884450142882 T3269009 00884450142882 T3322767 00884450142882 T3356295 K05T-01920F: 00884450260166 T3093916 00884450260166 T3148674 00884450260166 T3204048 00884450260166 T3322760 K05T-01955: 00884450140826 T2643557 00884450140826 T2719601 00884450140826 T2765333 00884450140826 T2823391 00884450140826 T2861459 00884450140826 T2909930 00884450140826 T2945617 00884450140826 T2985905 00884450140826 T3070951 00884450140826 T3111451 00884450140826 T3190818 00884450140826 T3214495 00884450140826 T3278749 00884450140826 T3322843 K05T-02138: 00884450140833 T2716870 00884450140833 T2726918 00884450140833 T2745251 00884450140833 T2983353 00884450140833 T3216028 K05T-02138A: 00884450095607 T3232335 00884450095607 T3271452 00884450095607 T3306685 K05T-02272G: 00884450684023 T2675577 00884450684023 T2726919 00884450684023 T2759596 00884450684023 T2774653 00884450684023 T2800975 00884450684023 T2810448 00884450684023 T2843256 K05T-02272H: 00884450814710 T2871522 00884450814710 T2898650 00884450814710 T2932783 00884450814710 T2985976 00884450814710 T2987768 00884450814710 T3043834 00884450814710 T3071604 00884450814710 T3105836 00884450814710 T3126557 00884450814710 T3185542 00884450814710 T3214496 00884450814710 T3229459 00884450814710 T3276962 00884450814710 T3309860 00884450814710 T3339469 K05T-02533: 00884450255803 T2718634 00884450255803 T2809725 00884450255803 T2849216 00884450255803 T2876922 00884450255803 T2899055 00884450255803 T2909932 00884450255803 T2981490 00884450255803 T3042476 00884450255803 T3071605 00884450255803 T3123415 00884450255803 T3181209 00884450255803 T3185434 00884450255803 T3293210 00884450255803 T3315474 00884450255803 T3336070 K05T-03153: 00884450463796 T2816275 00884450463796 T2850760 00884450463796 T2939991 00884450463796 T2985985 00884450463796 T3033317 00884450463796 T3202468 K05T-03201: 00884450547915 T2656028 00884450547915 T2690357 00884450547915 T2718635 00884450547915 T28233… (truncated, 5202 characters total — see the official FDA record for the full value)
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B

Inflation device handle may detach from the syringe during procedure.

ALL 50 STATES
Full report

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

Recall #:
98139
Lot/product code:
Reference Number/UDI Number/Lot Number(s) K12T-04270A: UDI: 00884450389683/ Lot: T2643938 T2728112 T2783917 T2806210 T2811252 K12T-07956: UDI: 00884450264003/ Lot: K2618155 K2618156 K12T-10922B: UDI: 00884450481660/Lot: T2851185 T2876341 T2990792 T3063197 T3070788 T3165727 T3223759 T3312055
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Allwell Inflation Device, for angiographic use REF: IS-30-A

Inflation device handle may detach from the syringe during procedure.

ALL 50 STATES
Full report

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

Recall #:
98139
Lot/product code:
UDI: 00884450653500 /Lot: I2559701 I2563344 I2567488 I2578111 I2593681 I2593683 I2603907 I2617788 I2622059 I2628990 I2653159 I2657407 I2853633 I2887859 I2887860 I2892046 I2917191 I2921522 I2927924 I2933535 I2989185 I2989187 I3027377 I3027378 I3037369 I3085686 I3085687 I3103552 I3118248 I3118249 I3154769 I3186052 I3186054 I3186058 I3214004 I3245239 I3245240 I3248078 I3282794
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

Full report

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

Recall #:
98215
Lot/product code:
Lot Code: UDI: 00886874119594 GTIN: 0886874119594 FDA Medical Device Listing Number: D414014 Part Number: 490127-01 Batch Numbers: DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 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(truncated, 94459 characters total — see the official FDA record for the full value)
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodChemicalRecalled December 4, 2025

Jumbo RAW SHRIMP, All Natural, Chemical Free, No artificial ingredients, NET WT. 32 OZ (2 LB) 907g UPC: 1 93968 00697 6

Elevated levels of chloramphenicol in frozen shrimp

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 #:
H-0401-2026
Lot/product code:
Product Codes: 231874 4D20 & 231874 4D21 Best By: 4/19/2026 & 4/20/2026
Recalling firm:
AZ Gems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Philips Incisive CT

Potential for incomplete scan due to unstable connection inside of floating sensor.

ALL 50 STATES
Full report

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

Recall #:
98238
Lot/product code:
N/A
Recalling firm:
Philips Healthcare (Suzhou) Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781342; UDI-DI: 00884838055339; Serial Numbers: 71607, 85216, 71087, 71619, 71462, 71002, 71885, 71841, 71378, 71269, 85126, 71279, 71088, 71185, 71532, 71344, 71756, 71336, 71459. (2) Product Code (REF): 781377; UDI-DI: 00884838009813; Serial Numbers: 42305, 42299, 42036, 42376, 42321.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. Product Code (REF): 782108. UDI-DI: 00884838098343. Serial Numbers: 48669.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781341; UDI-DI: 00884838055322; Serial Numbers: 70311, 84560, 84403, 84467, 84462, 70042, 84433. (2) Product Code (REF): 781396; UDI-DI: 00884838009820; Serial Numbers: 41356, 41354, 41370.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 782148. UDI-DI: 00884838108714. Serial Numbers: 70769, 70983. (2) Product Code (REF): 782116. UDI-DI: 00884838099722. Serial Number: 84741.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. Product Code (REF): 782143. UDI-DI: 00884838108660. Serial Numbers: 42225.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. Product Code (REF): 782145. UDI-DI: 00884838108684. Serial Numbers: 17385.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. Product Code (REF): 781271. UDI-DI: 00884838068452. Serial Numbers: 78017, 78112, 78217, 78123, 78260, 78239.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781356; UDI-DI: 00884838090040; Serial Numbers: 47206, 47038, 47068, 47260, 47294, 47029, 47189. (2) Product Code (REF): 782109; UDI-DI: 00884838098350; Serial Numbers: 47849, 47634, 47534, 47726, 47760, 47706, 47789, 47642, 47681, 47761, 47771, 47767, 47862. (3) Product Code (REF): 782138; UDI-DI: 00884838108622; Serial Numbers: 49057.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781357; UDI-DI: 00884838088108; Serial Numbers: 46002. (2) Product Code (REF): 782106; UDI-DI: 00884838098329; Serial Numbers: 46243, 46292. (3) Product Code (REF): 782137; UDI-DI: 00884838108615; Serial Numbers: 64034, 64045.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781358; UDI-DI: 00884838088115; Serial Numbers: 45414, 45245, 45090, 45049, 45034, 45250, 45075, 45290, 45320, 45011, 45191, 45277, 45278, 45028, 45147. (2) Product Code (REF): 782107; UDI-DI: 00884838098336; Serial Numbers: 62031, 45533, 62051, 62182, 62024, 62047, 62048, 62052, 45519, 62181, 62081, 62153, 62088, 45589, 62073. (3) Product Code (REF): 782136; UDI-DI: 00884838108608; Serial Numbers: 28503.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 782120; UDI-DI: 00884838104112; Serial Numbers: 65019, 65060, 65066, 65065, 65051, 65038, 65005. (2) Product Code (REF): 782153; UDI-DI: 00884838112858; Serial Numbers: 68010, 68017.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. Product Code (REF): 782130. UDI-DI: 00884838104402. Serial Numbers: 42030, 85644, 42163, 42151, 45236, 85643.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. Product Code (REF): 781270. UDI-DI: 00884838095083. Serial Numbers: 24066, 38113, 17356.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).

Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.

ALL 50 STATES
Full report

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

Recall #:
98097
Lot/product code:
version 2.0.2465 and 2.0.2683 UDI-DI (GTIN) 00763000520083 Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal

Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.

ALL 50 STATES
Full report

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

Recall #:
98149
Lot/product code:
1) GTIN 08714729796527, Batch Number 37370117, exp. 3-Sept-28; 2) GTIN 08714729796756, Batch Number 37416646, exp. 9-Sept-28
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

ALL 50 STATES
Full report

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

Recall #:
97546
Lot/product code:
Catalog Number: 1115-00 Software Versions: UDI-DI code for Hardware: 10885403518348 UDI-DI code for Software: 10885403520341 System Versions 1.6.1 - 1.11.0 Server Application Versions ES 4.13 - 5.8.X
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815609320 ; UDI-DI (01)00887868144479(17)340826(10)66717601 ; Lot Number 66717601 Model No 815609320 ; UDI-DI (01)00887868144479(17)340820(10)66892900 ; Lot Number 66892900
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceBacteria/virusCampylobacterRecalled December 2, 2025

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

ALL 50 STATES
Full report

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

Recall #:
98079
Lot/product code:
UDI-DI: 20845357006459; Lot Numbers: 325-120-3, 325-120-7, Additional Lots added 12/22/25: 325-119-1, 325-119-5
Recalling firm:
Microbiologics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815609380 ; UDI-DI (01)00887868144509(17)340826(10)66717604 ; Lot Number 66717604 Model No 815609380 ; UDI-DI (01)00887868144509(17)340820(10)66892903 ; Lot Number 66892903
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)