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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 7, 2025

Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

Full report

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

Recall #:
97994
Lot/product code:
Model/Catalog Number: R54544-18-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496899, 500956, 497076, 501169, 497584, 501188, 499227, 502430, 499417, 502951, 499461, 503306, 499897, 503430, 499898, 503529, 499899, 504180, 499908, 504543, 500407, 504823, 500477;
Recalling firm:
Rocket Medical Plc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2025

Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

Full report

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

Recall #:
97994
Lot/product code:
Model/Catalog Number: R54549-20-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496455, 499910, 496811, 500480, 496919, 501734, 497516, 503706, 499083, 504152;
Recalling firm:
Rocket Medical Plc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2025

Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

Full report

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

Recall #:
97994
Lot/product code:
Model/Catalog Number: R54544-18-SG; UDI-DI: 050552709TF06DXY; Lot Code: 496809, 501616, 497346, 501710, 497665, 502431, 498972, 503735, 499909, 503937, 500782, 504573, 501256, 504824;
Recalling firm:
Rocket Medical Plc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2025

Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

Full report

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

Recall #:
97994
Lot/product code:
Model/Catalog Number: R54544-12-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496708, 501186, 496903, 501548, 497147, 502122, 497292, 502317, 497344, 502534, 497664, 502949, 499226, 503201, 499276, 503429, 499415, 503732, 499462, 503899, 499806, 503935, 499902, 504283, 500404, 504581, 500474, 504637, 500757, 504821, 500955, 505025;
Recalling firm:
Rocket Medical Plc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

ALL 50 STATES
Full report

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

Recall #:
97985
Lot/product code:
Lot# NGJU4328/UDI: (01)00801741015922
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

ALL 50 STATES
Full report

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

Recall #:
97985
Lot/product code:
Lot# NGJU4327/UDI:(01)00801741015786
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,

Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.

ALL 50 STATES
Full report

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

Recall #:
97864
Lot/product code:
UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.

Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network

ALL 50 STATES
Full report

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

Recall #:
97871
Lot/product code:
Catalog Number: 8100 Material Number: 8100BDBDXEN1212 UDI-DI code: 10885403810046 Equipment/Software Version: 8100BD PUMP MODULE V12.1.2 DOM V12.1.2 Serial Numbers: 17377484 17377907 17377935 17377939 17377942 17377946 17377948 17377952 17377959 17377961 17377965 17377970 17377972 17377973 17377976 17377978 17377980 17377987 17377992 17377993 17378071 17378072 17378073 17378074 17378075 17378079 17378081 17378082 17378084 17378085 17378086 17378087 17378088 17378089 17378090 17378091 17378092 17378093 17378094 17378095 17378096 17378098 17378099 17378101 17378102 17378103 17378124 17378125 17378126 17378127 17378145 17378147 17378149 17378153 17378154 17378156 17378157 17378158 17378163 17378164 17378166 17378167 17378168 17378170 17378172 17378176 17378178 17378179 17378180 17378181 17378182 17378183 17378184 17378185 17378186 17378187 17378188 17378189 17378190 17378193 17378194 17378196 17378198 17378199 17378201 17378203 17378205 17378207 17378209 17378221 17378222 17378223 17378224 17378225 17378226 17378227 17378236 17378239 17378240 17378241 17378242 17378243 17378244 17378245 17378246 17378247 17378248 17378249 17378267 17378268 17378269 17378270 17378271 17378272 17378279 17378281 17378282 17378286 17378287 17378288 17378289 17378290 17378293 17378296 17378298 17378303 17378305 17378309 17378310 17378312 17378314 17378315 17378316 17378317 17378318 17378319 17378320 17378321 17378333 17378334 17378335 17378336 17378337 17378338 17378339 17378347 17378349 17378363 17378364 17378365 17378366 17378367 17378369 17378370 17378371 17378375 17378377 17378395 17378396 17378401 17378402 17378403 17378405 17378408 17378424 17378433 17378434 17378435 17378444 17378445 17378447 17378449 17378452 17378454 17378455 17378465 17378466 17378467 17378481 17378482 17378483 17378484 17378485 17378497 17378499 17378502 17378503 17378505 17378506
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

ALL 50 STATES
Full report

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

Recall #:
97985
Lot/product code:
Lot# NGJU4163/UDI: (01)00801741015403
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

ALL 50 STATES
Full report

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

Recall #:
97985
Lot/product code:
Lot# NGJU4181/UDI: (01)00801741015687
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled November 6, 2025

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0182-2026
Lot/product code:
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 5, 2025

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

Defective container - seal not adhering to bottles

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-0227-2026
Lot/product code:
Lot # QB00865, exp. date Feb 2028
Recalling firm:
Lupin Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Safety and efficacy of dialysis acid concentrate cannot be assured

ALL 50 STATES
Full report

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

Recall #:
97989
Lot/product code:
UDI: None/Lot Code: PHV08042
Recalling firm:
Diasol, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled November 5, 2025

Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

ALL 50 STATES
Full report

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

Recall #:
97942
Lot/product code:
UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
Recalling firm:
Accriva Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Safety and efficacy of dialysis acid concentrate cannot be assured

ALL 50 STATES
Full report

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

Recall #:
97989
Lot/product code:
UDI: None/Lot Code: PHV08112,PHV10082
Recalling firm:
Diasol, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Safety and efficacy of dialysis acid concentrate cannot be assured

ALL 50 STATES
Full report

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

Recall #:
97989
Lot/product code:
UDI: None/Lot Code: PHV08081,PHV09042
Recalling firm:
Diasol, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Safety and efficacy of dialysis acid concentrate cannot be assured

ALL 50 STATES
Full report

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

Recall #:
97989
Lot/product code:
UDI: None/Lot Code: PHV07221 PHV07241 PHV07291 PHV08182 PHV08201 PHV08221 PHV08271 PHV09031 PHV09051 PHV09101 PHV09111 PHV09152 PHV09171 PHV09241 PHV09251 PHV09261 PHV10071
Recalling firm:
Diasol, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Safety and efficacy of dialysis acid concentrate cannot be assured

ALL 50 STATES
Full report

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

Recall #:
97989
Lot/product code:
UDI: None/Lot Code: PHV07222,PHV09082
Recalling firm:
Diasol, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Safety and efficacy of dialysis acid concentrate cannot be assured

ALL 50 STATES
Full report

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

Recall #:
97989
Lot/product code:
UDI: None; Lot Code: PHV07181 PHV07211 PHV07231 PHV07251 PHV07281 PHV07282 PHV07301 PHV07302 PHV07311 PHV08011 PHV08041 PHV08051 PHV08061 PHV08071 PHV08111 PHV08121 PHV08131 PHV08132 PHV08141 PHV08151 PHV08181 PHV08251 PHV08252 PHV09021 PHV09041 PHV09081 PHV09091 PHV09121 PHV09151 PHV09161 PHV09181 PHV09191 PHV09221 PHV09231 PHV09291 PHV10031 PHV10061 PHV10081 PHV10091 PHV10131
Recalling firm:
Diasol, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

Product testing did not meet expected stability criteria.

ALL 50 STATES
Full report

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

Recall #:
97911
Lot/product code:
Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
Recalling firm:
Cepheid
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2025

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

ALL 50 STATES
Full report

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

Recall #:
97946
Lot/product code:
Model No. (UDI): 0998-00-0800-83 (10607567108407); ALL SERIAL NO.
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2025

Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

ALL 50 STATES
Full report

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

Recall #:
97946
Lot/product code:
Model No. (UDI): D998-00-0800-31 (10607567109053), D998-00-0800-32 (10607567111117), D998-00-0800-33 (10607567109008), D998-00-0800-35 (10607567109107), D998-00-0800-36 (10607567114187), D998-00-0800-45 (10607567108421), D998-00-0800-52 (10607567108438), D998-00-0800-53 (10607567108391), D998-00-0800-55 (10607567108414), D998-00-0800-65 (10607567113432), D998-UC-0800-31 (10607567109053), D998-UC-0800-33 (10607567109008), D998-UC-0800-52 (10607567108438), D998-UC-0800-53 (10607567108391), D998-UC-0800-55 (10607567108414); ALL SERIAL NO.
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Blood Type Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221708136; SKU: A-BG; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Pet Allergy Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785695; SKU: TI; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Neurotransmitters Plus

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612786449; SKU: F510; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)