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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 November 22, 2025

Vivoo Vaginal pH Test

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): Vivoo Vaginal pH Test/2024032219(03/21/2026)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2025

The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.

ALL 50 STATES
Full report

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

Recall #:
98103
Lot/product code:
08496633190 lot 840183 exp. 02/26 08496633190 lot 874011 exp. 10/26 08496609190 lot 840177 exp. 05/26
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2025

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

Emphasizing instructions for LVP duration programming located in the IFU.

ALL 50 STATES
Full report

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

Recall #:
98106
Lot/product code:
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2025

Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC

Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.

ALL 50 STATES
Full report

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

Recall #:
98125
Lot/product code:
UDI: 1041CE 00888277446727 (ea) 40888277446725 (case); HUD1035 10197344011575 (ea) 20197344011572 (case); HUD1042 10197344011544 (ea) 20197344011541 (case); HUD1930 10197344009626 (ea) 20197344009623 (case); HUDRHO41U 10197344010646 (ea) 20197344010643 (case) Lots: 24DOA701 25EOA321 25EOA589 25EOA724 25EOA730 25EOA781 25EOA857 25FOA151 25FOA152 25FOA153 25FOA206 25FOA218 25FOA219 25FOA220 25FOA221 25FOA275 25FOA287 25FOA288 25FOA418 25FOA419 25FOA420 25FOA421 25FOA422 25FOA514 25FOA515 25FOA524 25FOA525 25FOA551 25FOA552 25FOA553 25FOA556 25FOA557 25FOA642 25FOA643 25FOA647 25FOA648 25FOA649 25FOA650 25FOA722 25FOA740 25FOA864 25FOA865 25FOA866 25GOA055 25GOA065 25GOA066 25GOA077 25GOA078 25GOA096 25GOA098 25GOA190 25GOA210 25GOA211 25GOA328 25GOA363 25GOA364 25GOA365 25GOA366 25GOA367 25GOA437 25GOA445 25GOA446 25GOA561 25GOA562 25GOA563 25GOA564 25GOA565 25GOA640 25GOA641 25GOA648 25GOA655 25GOA735 25GOA736 25GOA756 25GOA757 25GOA758 25GOA759 25GOA760 25GOA761 25GOA766 25GOA830 25GOA994 25GOA998 25HOA009 25HOA011 25HOA017 25HOA018 25HOA019 25HOA020 25HOA021 25HOA022 25HOA060 25HOA061 25HOA071 25HOA247 25HOA249 25HOA252 25HOA253 25HOA254 25HOA255 25HOA256 25HOA316 25HOA335 25HOA372 25HOA373 25HOA452 25HOA455 25HOA456 25HOA457 25HOA458 25HOA459 25HOA460 25HOA462 25HOA469 25HOA474 25HOA478 25HOA532 25HOA533 25HOA538 25HOA629 25HOA630 25HOA631 25HOA632 25HOA633 25HOA639 25HOA644 25HOA723 25HOA724 25HOA734 25HOA829 25HOA830 25HOA831 25HOA832 25HOA833 25HOA853 25IOA020 25IOA021 25IOA090 25IOA097 25IOA163 25IOA164 25IOA165 25IOA166 25IOA244 25IOA246 25IOA247 25IOA253 25IOA363 25IOA364 25IOA365 25IOA366 25IOA367 25IOA368 25IOA369 25IOA410 25IOA438 25IOA439 25IOA520 25IOA521 25IOA522 25IOA523 25IOA524 25IOA525 25IOA526 25IOA527 25IOA637 25IOA638 25IOA668 25IOA682 25IOA683 25IOA684 25IOA685 25IOA686 25IOA687 25IOA688 25IOA743 25IOA787 25JOA027 25JOA032 25JOA047 25JOA048 25JOA049 25JOA050 25JOA051 25JOA052 25JOA053 25JOA179 25JOA213 25JOA215 25JOA243 25JOA246 25JOA247 25JOA248 25JOA249 25JOA250 25JOA251 25JOA252 25JOA253 25JOA386 25JOA430 25JOA467 25JOA561 25JOA562 25JOA563 25JOA564 25JOA579 25JOA670 25JOA675 25JOA757 25JOA758 25JOA760 25JOA762 25JOA763 25JOA778 25JOA779 25JOA780 25JOA832 25JOA835 25JOA856 25JOA940 25JOA941 25JOA942 25KOA050 25KOA051
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 21, 2025

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0199-2026
Lot/product code:
Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 20, 2025

Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

ALL 50 STATES
Full report

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

Recall #:
98028
Lot/product code:
CP App: UDI-DI 00763000273668 all software versions prior to v.1.0.4489 are affected The implanted devices are not affected.
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 20, 2025

BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main, REF: 1155-00, BD Pyxis CII Safe ES, REF: 1116-00

Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.

ALL 50 STATES
Full report

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

Recall #:
97712
Lot/product code:
Firmware Version: 1.48. REF/UDI-DI: 323/10885403512667, 324/10885403512681, 352/10885403512674, 1149-00/10885403517822, 1152-00/10885403517839, 1155-00/10885403521300, 1116-00/10885403512605
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2025

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01

Incorrect Product Formulation

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-0221-2026
Lot/product code:
Lot#: C274-000047958; Exp. December 19, 2025
Recalling firm:
Fagron Compounding Services
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2025

Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;

Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

ALL 50 STATES
Full report

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

Recall #:
98032
Lot/product code:
UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2025

AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

ALL 50 STATES
Full report

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

Recall #:
97986
Lot/product code:
Lot Code: UDI:00724995176587, 00724995176594, 00724995176570 Serial number of distributed units: 3619625011, 3621625009, 3621625012, 3621925006, 3621925009, 3622425006, 3622725007, 3623425005, 3623825002, 3624525002
Recalling firm:
Steris Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2025

AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

ALL 50 STATES
Full report

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

Recall #:
97986
Lot/product code:
Lot Code: UDI: 00724995176662, 00724995176679, 00724995176655 Serial numbers of distributed units: 3619725008, 3619725011, 3619725013, 3621625010, 3621625011, 3621625013, 3621625014, 3621625015, 3621925001, 3621925002, 3621925005, 3621925010, 3622425005, 3622725005, 3622725011, 3622725012, 3623125006, 3623425016, 3623825008, 3624025002, 3624025008, 3624525007
Recalling firm:
Steris Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2025

Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.

ALL 50 STATES
Full report

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

Recall #:
98101
Lot/product code:
N/A
Recalling firm:
AGFA Healthcare Corp.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 18, 2025

Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.

Cross Contamination with Other Products

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0222-2026
Lot/product code:
Lot# 17240988; Exp. 05/31/2026
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2025

Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)

When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.

ALL 50 STATES
Full report

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

Recall #:
97969
Lot/product code:
Audio Driver Version: 6.0.9484.1. UDI-DI: 06936415972417. HP Pro Mini 400 G9 Desktop PC. Realtek HD Audio Driver Released by HP. 1. WS host package (mini PC). Part Number 115-050935-00. Quantity 902 2. Exch, Benevision Mini PC Workstation. Part Number E115-050935-00. Quantity 4
Recalling firm:
Mindray DS USA, Inc. dba Mindray North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2025

Intelerad InteleShare software, with ProViewer component

Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.

Full report

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

Recall #:
97993
Lot/product code:
Software versions 3.24.3 - 3.25.2. Date of First Distribution: 2024-08-28. UDI-DI: B228INTELESHARE0
Recalling firm:
DICOM Grid, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2025

Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.

A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.

ALL 50 STATES
Full report

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

Recall #:
98087
Lot/product code:
(1) Model/Catalog Number: 1530101; UDI-DI: TBD; (2) Model/Catalog Number: 1530102; UDI-DI: TBD;
Recalling firm:
ETAC A/S
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2025

Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

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-0239-2026
Lot/product code:
Lot: J1325J, I1725P, EXP Date: 4/30/2027.
Recalling firm:
Preferred Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2025

Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;

A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.

ALL 50 STATES
Full report

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

Recall #:
98087
Lot/product code:
(1) Model/Catalog Number: M14000; UDI-DI: 05707995032270; Serial Numbers: 616606, 616604, 591003, 591002, 590906, 590901, 590904, 590903, 590902, 591001, 604101, 604005, 591703, 591007, 591006, 591005, 591004, 615105, 615104, 615103, 615102, 615101, 604004, 604003, 604002, 604001, 614202, 614201, 591702, 591701, 616603, 615106, 590905; (2) Model/Catalog Number: M1401; UDI-DI: 05707995032270; Serial Numbers: 593302, 593301, 593303, 612507, 612506, 612508, 612505, 612503, 620702, 612504, 612502, 612501, 593304, 593305, 620703, 620701; (3) Model/Catalog Number: M1402; UDI-DI: 05707995032270; Serial Numbers: 612601; (4) Model/Catalog Number: M14050; UDI-DI: 05707995032270; Serial Numbers: 590801, 596701, 585701, 584501, 591801, 604405, 604406, 604402, 604404, 604403, 604401, 604303, 604302, 604301; (5) Model/Catalog Number: M14150; UDI-DI: 05707995032270; Serial Numbers: 585811, 585810, 585809, 585808, 585806, 585805, 585804, 585803, 585801, 596604, 596603, 596602, 596601, 596611, 596610, 596609, 596608, 596607, 596606, 596605, 585807, 585802; (6) Model/Catalog Number: M1402-01; UDI-DI: 05707995032270; Serial Numbers: 612701, 612703, 612702; (7) Model/Catalog Number: M14050-00; UDI-DI: 05707995032270; Serial Numbers: 584307; (8) Model/Catalog Number: M14001; UDI-DI: 05707995032270; Serial Numbers: 603501, 599801, 599802, 604202, 604201;
Recalling firm:
ETAC A/S
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2025

Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover.

A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.

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

Recall #:
98087
Lot/product code:
(1) Model/Catalog Number: M1501; UDI-DI: TBD; Serial Numbers: 601005, 601002, 611506, 621101, 621106, 621104, 621105, 621102, 611505, 611504, 611503, 611502, 611501, 601008, 611507, 601007, 601006, 601001, 621103, 601003, 601004; (2) Model/Catalog Number: M1502; UDI-DI: TBD; Serial Numbers: 611409, 611408, 611407, 611406, 611405, 611404, 611403, 611402, 611401, 611412, 611411, 611410; (3) Model/Catalog Number: M1504; UDI-DI: TBD; Serial Numbers: 600902, 600901, 611303, 611302, 611301; (4) Model/Catalog Number: M15050; UDI-DI: TBD; Serial Numbers: 586003, 586001, 585905, 585903, 585902, 585901, 598605, 586101, 585904, 603602, 591401, 586002, 586006, 586005, 586004, 598608, 598607, 585906, 591601, 598606, 598604, 598602, 598601, 596501, 603601, 598609, 598603; (5) Model/Catalog Number: M15151; UDI-DI: TBD; Serial Numbers: 599703, 599702, 599701; (6) Model/Catalog Number: M15001; UDI-DI: TBD; Serial Numbers: 584401; (7) Model/Catalog Number: M15002; UDI-DI: TBD; Serial Numbers: 591501, 591502;
Recalling firm:
ETAC A/S
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UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2025

Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.

A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.

ALL 50 STATES
Full report

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

Recall #:
98087
Lot/product code:
(1) Model/Catalog Number: 1430116; UDI-DI: TBD; (2) Model/Catalog Number: 1430117; UDI-DI: TBD; (3) Model/Catalog Number: 1430115; UDI-DI: TBD;
Recalling firm:
ETAC A/S
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UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2025

The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

Customer complaints of Pressio monitor rebooting.

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

Recall #:
98073
Lot/product code:
UDI/DI 03760124132076, All monitors
Recalling firm:
Sophysa
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UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2025

Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,

Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.

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

Recall #:
98068
Lot/product code:
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
Recalling firm:
Sheathing Technologies Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2025

GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S

Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

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Full report

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

Recall #:
98064
Lot/product code:
FRU 2076139-001-S, distributed between June 2, 2025 and October 21, 2025
Recalling firm:
GE Medical Systems China Co., Ltd.
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UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2025

GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543

Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

ALL 50 STATES
Full report

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

Recall #:
98064
Lot/product code:
REF 1012-9620-222: GTIN 00195278626301; REF 1012-9620-000: GTIN 00840682103985; REF 1012-9620-200: GTIN 00195278439536; REF 1012-9620-202: GTIN 00195278626158; REF 1012-9620-212: GTIN 00195278626561; REF 1012-9650-222: GTIN 00195278626592; REF 1012-9650-000: GTIN 00840682103947; REF 1012-9650-200: GTIN 00195278439529; REF 1012-9650-202: GTIN 00195278626585; REF 1012-9650-212: GTIN 00195278625687; REF 1012-9655-202: GTIN 00195278625953; REF 1012-9620-002: GTIN 00840682124546; REF 1012-9620-012: GTIN 00195278569677; REF 1012-9650-002: GTIN 00840682124560; REF 1012-9650-012: GTIN 00195278569684; REF 1012-9655-000: GTIN 00840682103954; REF 1012-9655-002: GTIN 00840682124539; REF 1012-9655-200: GTIN 00195278439543.
Recalling firm:
GE Medical Systems China Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2025

GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002

Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

ALL 50 STATES
Full report

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

Recall #:
98064
Lot/product code:
REF 1012-9750-000: GTIN 00840682145596; REF 1012-9750-002: GTIN 00840682146470; REF 1012-9755-000: GTIN 00840682146425; REF 1012-9755-002: GTIN 00840682146463.
Recalling firm:
GE Medical Systems China Co., Ltd.
View official FDA record (opens in a new tab)