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Recalls affecting Montana

Data last updated: September 10, 2026 at 1:16 PM UTC

16,379 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 January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 333150 338842 341492 347125 351529 351530 358480 359845 364533 367814 369363 370406 377839 380043 380044 381527 381528 382443 382444 382445
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2021

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

ALL 50 STATES
Full report

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

Recall #:
87221
Lot/product code:
Outer box GTIN: 08714729019251 Inner pouch GTIN: 08714729747680 Lot/Batch#: 24725319, 24782695,   Outer box GTIN: 08714729019312 Inner pouch GTIN: 08714729747833 Lot/Batch#: 24842597, 24812577,   Outer box GTIN: 08714729019336 Inner pouch GTIN: 08714729747857 Lot/Batch#: 24889757, 24719202, 24709536, 24773287,   Outer box GTIN: 08714729019350 Inner pouch GTIN: 08714729747871 Lot/Batch#: 24782693, 24732964, 24889755, 24780939,   Outer box GTIN: 08714729071068 Inner pouch GTIN: 08714729747970 Lot/Batch#: 24882357, 24782689, 24782687, 24729758,   Outer box GTIN: 08714729019411 Inner pouch GTIN:08714729747932 Lot/Batch#: 24961643  Outer box GTIN:08714729501640 Inner pouch GTIN: 08714729747932 Lot/Batch#: 24961645, 24989260, 24844193,   Outer box GTIN:08714729501657 Inner pouch GTIN:08714729747956 Lot/Batch#: 25010054,   Outer box GTIN:08714729019459 Inner pouch GTIN:08714729747994 Lot/Batch#: 25016793.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2021

Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

ALL 50 STATES
Full report

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

Recall #:
87221
Lot/product code:
Outer box GTIN: 08714729855934 Inner pouch GTIN: 08714729861263 Lot/Batch#: 25053639  Outer box GTIN: 08714729855903 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24948407, 24670592, 24679619, 24676929, 24939628  Outer box GTIN: 08714729861300 Inner pouch GTIN: 087147298 61294 Lot/Batch#: 24770325, 24952552, 24665104  Outer box GTIN: 08714729861317 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24679614, 25054403  Outer box GTIN: 08714729861348 Inner pouch GTIN: 08714729861324 Lot/Batch#: 24772995
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2021

Enteral Infusion Pump

The potential for air appearing in the enteral feed pumping set tubing during set-up.

ALL 50 STATES
Full report

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

Recall #:
87281
Lot/product code:
Catalog Number: 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2021

Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers C6387 See updated product list attached for details.

Non-sterile product was shipped to customers labelled as sterile.

ALL 50 STATES
Full report

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

Recall #:
87258
Lot/product code:
Lot Number L-008926-16037 Lot numbers L-008918-16048, and L-008918-16045  Lot numbers L-008936-16275, and L-008933-16078
Recalling firm:
ReNovo, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2021

Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures.

Product was distributed without receiving regulatory clearance.

ALL 50 STATES
Full report

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

Recall #:
87434
Lot/product code:
Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2021

Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

ALL 50 STATES
Full report

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

Recall #:
87221
Lot/product code:
Outer box GTIN: 08714729283904 Inner pouch GTIN: 08714729747598 Lot/Batch#: 24818278, 24906823, 25042455  Outer box GTIN: 08714729283928 Inner pouch GTIN: 08714729747611 Lot/Batch#: 24685766, 24817145, 24899710, 24739786, 25006735, 24861901  Outer box GTIN: 08714729158110 Inner pouch GTIN: 08714729748069 Lot/Batch#: 24685764, 24890051, 24824132  Outer box GTIN: 08714729268802 Inner pouch GTIN: 08714729748069 Lot/Batch#: 25023345  Outer box GTIN: 08714729158141 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24699718, 24939626, 24861739  Outer box GTIN: 08714729268819 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24824134, 25006729, 24709534  Outer box GTIN: 08714729501664 Inner pouch GTIN: 08714729748083 Lot/Batch#: 25023203, 24697822, 24739587, 24942292, 24909214, 24824136  Outer box GTIN: 08714729158158 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24856636, 24927642, 24699218  Outer box GTIN: 08714729268826 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24835709, 24818605, 25023343  Outer box GTIN: 08714729501671 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24909216, 24758832, 24872119, 24994171, 25048397, 2475126, 24929431, 24995438
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 25, 2021

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0249-2021
Lot/product code:
Lot MET200601, 07/2022
Recalling firm:
Nostrum Laboratories Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 27, 2021

Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.

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-0304-2021
Lot/product code:
Lot #: 148992, Exp 5/31/2022
Recalling firm:
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled January 27, 2021

Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.

ALL 50 STATES
Full report

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

Recall #:
D-0303-2021
Lot/product code:
a) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022
Recalling firm:
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 29, 2021

S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD

The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use.

ALL 50 STATES
Full report

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

Recall #:
87331
Lot/product code:
Serial Numbers: 2258046 2863490
Recalling firm:
Stryker Communications
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 1, 2021

Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

ALL 50 STATES
Full report

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

Recall #:
87274
Lot/product code:
Catalog Numbers 7201 (lots 0217H, 0317J, 0417B, 0417F, 0417H, 0618K, 0718B, 0718D, 0718F, 0419J, 0519J, 0120F, 0420B, 0720K, 0720M, 0820L, 0117D, 0117F, 1020L); 7205 (lots 0217B, 0317L); 7206 (lots 0217B, 0317L); 7201-01 (lots 0920B, 0920D, 0920H); 7203 (0217F, 0317B, 0317L, 0417H).
Recalling firm:
Bovie Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 1, 2021

HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

ALL 50 STATES
Full report

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

Recall #:
87274
Lot/product code:
Catalog Numbers HNM-31-150365 (lots 1017G, 1117B, 1217B, 0418C, 0518D, 0518H, 0618B, 0618D, 0818E, 1018J, 1018M, 1118J, 1218B, 1119B, 0420H, 0820H); HNM-31-150367 (lot 1117D); HNM-31-150368 (lot 1117D).
Recalling firm:
Bovie Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 1, 2021

ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

ALL 50 STATES
Full report

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

Recall #:
87274
Lot/product code:
Catalog Numbers C3390A (lots 0317F, 0417B, 0517B, 0517D, 0517J, 0617D, 0617F, 0617H, 0617K, 0717A, 0717G, 0817B, 0917G, 0917J, 1017C, 1017E, 1017J, 1117B, 0418C); C3350A (lots 0317F, 0417B, 0517B, 0517G, 0717C, 0817D, 0917C, 0917E); C3350NA (lots 0317F, 0517G, 0817F); C2455NA (lots 0317F, 0517B, 0717E, 1017C, 1017E); C1860NA (lots 0317F, 0517B, 0717E, 0817F, 1017G, 0418E); C3390NA (lots 0317F, 0517G, 0817H, 1017J, 0418E, 0518F, 1218C).
Recalling firm:
Bovie Medical Corporation
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled February 2, 2021

Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0796-4 UPC 360505079543 (carton) NDC 60505-0796-0 UPC (01)10360505079602 (label)

Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)

ALL 50 STATES
Full report

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

Recall #:
D-0262-2021
Lot/product code:
Batch: CT003 Exp. 05/2022
Recalling firm:
Apotex Corp.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled February 2, 2021

Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label)

Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)

ALL 50 STATES
Full report

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

Recall #:
D-0261-2021
Lot/product code:
Batch: CS008 Exp. 04/2022
Recalling firm:
Apotex Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 3, 2021

Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide cardiac resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

ALL 50 STATES
Full report

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

Recall #:
87261
Lot/product code:
1) Viva family: MODEL NUMBER / NAME / GTIN: SERIAL NUMBERS BLF244376H, BLF243732H, BLF244567H, BLF243795H, BLF244186H, BLF244478H, BLF243894H, BLF243453H, BLF244610H, BLF244627H, BLF243514H, BLF242936H, BLF244189H, BLF243735H, BLF243429H, BLF244637H, BLF235234H, BLF242865H, BLF243129H, BLF243389H, BLF242685H, BLF243087H, BLF243671H, BLF243888H, BLF243897H, BLF244660H, BLF242664H, BLF242935H, BLF243975H, BLF243028H, BLF243445H, BLF243396H, BLF243947H, BLF243377H, BLF242659H, BLF244047H, BLF243393H, BLF243714H, BLF242861H, BLF243366H, BLF243378H, BLF242874H, BLF243382H, BLF243750H, BLF242082H, BLF242682H, BLF243363H, BLF243386H, BLF243413H, BLF243450H, BLF243452H, BLF243752H, BLF243513H, BLF243181H, BLF242551H, BLF243371H, BLF243772H, BLF241960H, BLF243455H, BLF243258H, BLF243391H, BLF243398H, BLF243401H, BLF243408H, BLF243055H, BLF244654H, BLF241810H, BLF242439H, BLF244207H, BLF243460H, BLF244390H, BLF241286H, BLF242713H, BLF242875H, BLF243142H, BLF243439H, BLF244165H, BLF242857H, BLF241855H, BLF243385H, BLF244651H, BLF242395H, BLF243179H, BLF242005H, BLF243442H, BLF244061H, BLF243397H, BLF242133H, BLF243010H, BLF243418H, BLF243435H, BLF243464H, BLF244080H, BLF240020H, BLF242060H, BLF242096H, BLF242674H, BLF242711H, BLF243068H, BLF243171H, BLF243430H, BLF243444H, BLF241170H, BLF244117H, BLF243086H, BLF243936H, BLF242691H, BLF243136H, BLF240023H, BLF242666H, BLF243941H, BLF243877H, BLF241596H, BLF242696H, BLF240265H, BLF241136H, BLF243474H, BLF240009H, BLF243059H, BLF243935H, BLF240016H, BLF241267H, BLF242876H, BLF241795H, BLF242444H, BLF243432H, BLF241869H, BLF243407H, BLF241846H, BLF242068H, BLF243808H, BLF243019H, BLF242260H, BLF243518H, BLF243506H, BLF244134H, BLF240017H, BLF242923H, BLF243089H, BLF240406H, BLF242391H, BLF242658H, BLF243096H, BLF240648H, BLF241838H, BLF241848H, BLF243495H, BLF240003H, BLF242405H, BLF242663H, BLF240032H, BLF241760H, BLF242324H, BLF242657H, BLF242707H, BLF244003H, BLF239398H, BLF240010H, BLF236242H, BLF240008H, BLF243030H, BLF243082H, BLF243479H, BLF243480H, BLF238259H, BLF238700H, BLF239843H, BLF242063H, BLF243447H, BLF240024H, BLF240547H, BLF242348H, BLF243056H, BLF243090H, BLF243105H, BLF239263H, BLF241473H, BLF242940H, BLF239773H, BLF240033H, BLF242708H, BLF243231H, BLF243667H, BLF238847H, BLF242209H, BLF240083H, BLF242680H, BLF242709H, BLF239264H, BLF242784H, BLF240503H, BLF243138H, BLF242471H, BLF243406H, BLF239866H, BLF241016H, BLF240879H, BLF241839H, BLF243034H, BLF243369H, BLF244112H, BLF243419H, BLF243708H, BLF241847H, BLF243405H, BLF243491H, BLF241851H, BLF242075H, BLF240794H, BLF241091H, BLF243424H, BLF239117H, BLF239889H, BLF242080H, BLF243976H, BLF244652H, BLF239615H, BLF242014H, BLF240857H, BLF243168H, BLF243791H, BLF240782H, BLF240830H, BLF242100H, BLF242779H, BLF243426H, BLF243449H, BLF243648H, BLF244128H, BLF244497H, BLF239864H, BLF242009H, BLF239244H, BLF239351H, BLF241853H, BLF241824H, BLF242007H, BLF242035H, BLF242204H, BLF242811H, BLF243511H, BLF233474H, BLF242026H, BLF242062H, BLF242910H, BLF243583H, BLF244009H, BLF238616H, BLF239587H, BLF240472H, BLF241836H, BLF241850H, BLF242024H, BLF242507H, BLF243373H, BLF243415H, BLF244508H, BLF239718H, BLF242021H, BLF242453H, BLF242808H, BLF243988H, BLF244500H, BLF242011H, BLF243955H, BLF244225H, BLF244573H, BLF240691H, BLF244431H, BLF242669H, BLF242817H, BLF244592H, BLF242008H, BLF238801H, BLF243255H, BLF235186H, BLF242114H, BLF242458H, BLF242877H, BLF238492H, BLF240026H, BLF239089H, BLF241043H, BLF241675H, BLF244655H, BLF243212H, BLF242249H, BLF243134H, BLF235187H, BLF236322H, BLF240612H, BLF239475H, BLF240856H, BLF241021H, BLF244471H, BLF244400H, BLF241010H, BLF243715H, BLF237913H, BLF238189H, BLF243062H, BLF244126H, BLF238047H, BLF243496H, BLF242066H, BLF239803H, BLF243857H, BLF244274H, BLF244562H, BLF236223H, BLF241307H, BLF242386H, BLF243473H, BLF243874H, BLF244381H, BLF244646H, BLF241843H, BLF244658H, BLF237433H, BLF238074H, BLF242735H, BLF235855H, BLF236051H, BLF242715H, BLF243294H, BLF243434H, BLF243274H, BLF241507H, BLF243198H, BLF243392H, BLF243505H, BLF243563H, BLF244312H, BLF241458H, BLF243451H, BLF243458H, BLF240776H, BLF244203H, BLF236843H, BLF236967H, BLF243061H, BLF237015H, BLF240254H, BLF240662H, BLF243612H, BLF241809H, BLF242334H, BLF242448H, BLF242812H, BLF244326H, BLF242901H, BLF243271H, BLF243652H, BLF244555H, BLF231669H, BLF235896H, BLF236939H, BLF238586H, BLF240895H, BLF243113H, BLF243762H, BLF241104H, BLF243525H, BLF243675H, BLF234586H, BLF238437H, BLF243388H, BLF243481H, BLF236549H, BLF239751H, BLF242896H, BLF243994H, BLF236965H, BLF243336H, BLF242639H, BLF235829H, BLF236571H, BLF241570H, BLF243423H, BLF244191H, BLF242221H, BLF244536H, BLF244159H, BLF238282H, BLF238845H, BLF238846H, BLF239749H, BLF234862H, BLF244276H, BLF235394H, BLF237489H, BLF243818H, BLF244071H, BLF235640H, BLF242889H, BLF243960H, BLF241297H, BLF239566H, BLF243687H, BLF244215H, BLF235675H, BLF240908H, BLF241314H, BLF241478H, BLF242645H, BLF243582H, BLF243906H, BLF241715H, BLF244467H, BLF233023H, BLF239304H, BLF2434… (truncated, 2884485 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 3, 2021

Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.

Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.

ALL 50 STATES
Full report

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

Recall #:
87319
Lot/product code:
Product: DV HDLC; Lot #: 20062BA; UDI Number: 0084276802043820062BA21030210464340840
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 3, 2021

Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.

A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

ALL 50 STATES
Full report

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

Recall #:
87261
Lot/product code:
1) Evera Family: MODEL NUMBER / NAME / GTIN: SERIAL NUMBERS: DDBB1D1 / ICD-DR DDBB1D1 EVERA XT US IS1/DF1 / 00643169018099: BWC231766H, BWC230184H, BWC230891H, BWC228489H, BWC232037H, BWC230770H, BWC231219H, BWC231215H, BWC231190H, BWC231202H, BWC231199H, BWC231780H, BWC231556H, BWC230255H, BWC230772H, BWC230906H, BWC231500H, BWC231572H, BWC231618H, BWC231655H, BWC231937H, BWC231942H, BWC230859H, BWC230949H, BWC231848H, BWC230918H, BWC231237H, BWC231580H, BWC230893H, BWC231576H, BWC230426H, BWC230475H, BWC230431H, BWC231494H, BWC230876H, BWC230776H, BWC228873H, BWC229321H, BWC230873H, BWC229698H, BWC230449H, BWC231452H, BWC230877H, BWC230720H, BWC231479H, BWC231482H, BWC231578H, BWC231498H, BWC229796H, BWC230863H, BWC230874H, BWC231239H, BWC230917H, BWC229337H, BWC230524H, BWC230887H, BWC231525H, BWC231240H, BWC230672H, BWC230769H, BWC232164H, BWC232196H, BWC230048H, BWC230520H, BWC231568H, BWC231671H, BWC231761H, BWC229598H, BWC230335H, BWC230889H, BWC231570H, BWC228859H, BWC230914H, BWC231346H, BWC230884H, BWC231501H, BWC229058H, BWC229697H, BWC228813H, BWC232165H, BWC230870H, BWC230901H, BWC231259H, BWC230872H, BWC231106H, BWC230195H, BWC230911H, BWC228448H, BWC229342H, BWC230535H, BWC230655H, BWC230919H, BWC231269H, BWC231480H, BWC231668H, BWC230044H, BWC228426H, BWC230910H, BWC227091H, BWC231456H, BWC229099H, BWC229101H, BWC231874H, BWC228336H, BWC230869H, BWC230730H, BWC230630H, BWC231872H, BWC231343H, BWC228800H, BWC228656H, BWC228666H, BWC229097H, BWC231944H, BWC226887H, BWC230885H, BWC231768H, BWC232133H, BWC227119H, BWC228318H, BWC229963H, BWC230899H, BWC228760H, BWC230159H, BWC230882H, BWC230381H, BWC228544H, BWC230098H, BWC231400H, BWC228205H, BWC228858H, BWC226830H, BWC230454H, BWC228816H, BWC230608H, BWC228988H, BWC227088H, BWC228586H, BWC226816H, BWC227609H, BWC228180H, BWC228449H, BWC229289H, BWC229600H, BWC230118H, BWC230732H, BWC232122H, BWC231241H, BWC228818H, BWC229317H, BWC229344H, BWC229118H, BWC230071H, BWC227808H, BWC232126H, BWC232191H, BWC232170H, BWC227125H, BWC227610H, BWC227114H, BWC230530H, BWC227067H, BWC227782H, BWC228871H, BWC228399H, BWC228427H, BWC231659H, BWC228044H, BWC228820H, BWC228206H, BWC229013H, BWC231037H, BWC231809H, BWC226906H, BWC229163H, BWC227324H, BWC228320H, BWC227017H, BWC227077H, BWC227034H, BWC227374H, BWC228469H, BWC231485H, BWC225637H, BWC227113H, BWC228867H, BWC231257H, BWC227047H, BWC227071H, BWC224560H, BWC226819H, BWC226824H, BWC226960H, BWC227129H, BWC228864H, BWC230020H, BWC231332H, BWC231458H, BWC226403H, BWC226833H, BWC227056H, BWC227062H, BWC227126H, BWC228869H, BWC226939H, BWC227326H, BWC230083H, BWC231865H, BWC229346H, BWC231669H, BWC227323H, BWC230503H, BWC231049H, BWC228832H, BWC229536H, BWC226805H, BWC226822H, BWC226914H, BWC231406H, BWC228248H, BWC225448H, BWC226799H, BWC227109H, BWC228132H, BWC229168H, BWC231459H, BWC231673H, BWC226801H, BWC226817H, BWC228812H, BWC231043H, BWC231192H, BWC229055H, BWC226987H, BWC231173H, BWC229988H, BWC226820H, BWC226831H, BWC230642H, BWC226798H, BWC229516H, BWC229886H, BWC231781H, BWC226832H, BWC225279H, BWC226809H, BWC226812H, BWC227130H, BWC228297H, BWC229806H, BWC226664H, BWC230704H, BWC231684H, BWC226998H, BWC230322H, BWC225786H, BWC226298H, BWC227032H, BWC230010H, BWC231324H, BWC224500H, BWC229757H, BWC230573H, BWC227008H, BWC230091H, BWC231550H, BWC225592H, BWC226988H, BWC227163H, BWC227322H, BWC224540H, BWC230309H, BWC232166H, BWC227025H, BWC230791H, BWC231036H, BWC227845H, BWC230784H, BWC232050H, BWC226416H, BWC226966H, BWC228943H, BWC228960H, BWC228978H, BWC231908H, BWC228014H, BWC228050H, BWC229537H, BWC226984H, BWC227330H, BWC231176H, BWC231412H, BWC229009H, BWC230481H, BWC226584H, BWC229898H, BWC225730H, BWC226415H, BWC226924H, BWC227316H, BWC227321H, BWC230411H, BWC226578H, BWC229981H, BWC230279H, BWC224159H, BWC225056H, BWC230137H, BWC229606H, BWC231774H, BWC225810H, BWC226471H, BWC227919H, BWC228962H, BWC229743H, BWC230565H, BWC228743H, BWC231660H, BWC225960H, BWC228522H, BWC232106H, BWC232113H, BWC225555H, BWC227536H, BWC228919H, BWC228974H, BWC208701H, BWC231047H, BWC226182H, BWC231976H, BWC226398H, BWC226639H, BWC229914H, BWC230318H, BWC230916H, BWC230937H, BWC231395H, BWC232174H, BWC226053H, BWC228270H, BWC225617H, BWC226923H, BWC228131H, BWC229142H, BWC230648H, BWC231137H, BWC224556H, BWC224377H, BWC225611H, BWC226587H, BWC228342H, BWC229758H, BWC230247H, BWC230404H, BWC224492H, BWC228171H, BWC228363H, BWC228582H, BWC229921H, BWC230590H, BWC230691H, BWC231024H, BWC231250H, BWC231392H, BWC232118H, BWC232181H, BWC222232H, BWC223575H, BWC226139H, BWC226703H, BWC227005H, BWC227196H, BWC228392H, BWC228969H, BWC229071H, BWC229414H, BWC230028H, BWC230181H, BWC231490H, BWC231729H, BWC231864H, BWC231997H, BWC232155H, BWC232206H, BWC225667H, BWC226056H, BWC226643H, BWC231184H, BWC232115H, BWC226299H, BWC227028H, BWC228060H, BWC227023H, BWC228445H, BWC229075H, BWC229787H, BWC232001H, BWC220805H, BWC225084H, BWC227612H, BWC227882H, BWC228414H, BWC230410H, BWC230774H, BWC231403H, BWC231549H, … (truncated, 3486040 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 5, 2021

System INFX-8000C

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

ALL 50 STATES
Full report

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

Recall #:
87419
Lot/product code:
Model: CAS-880A, CAS-830B
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 5, 2021

System INFX-8000V

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

ALL 50 STATES
Full report

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

Recall #:
87419
Lot/product code:
Model: CAS-880A, CAS-830B
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 5, 2021

System INFX-8000F

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

ALL 50 STATES
Full report

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

Recall #:
87419
Lot/product code:
Model: CAS-880A, CAS-830B
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 7, 2021

NM/CT 870 DR Nuclear Medicine / CT Scanners

GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

ALL 50 STATES
Full report

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

Recall #:
87811
Lot/product code:
GTIN*00840682140836
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 7, 2021

NM/CT 860 Nuclear Medicine / CT Scanners

GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

ALL 50 STATES
Full report

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

Recall #:
87811
Lot/product code:
GTIN*00840682140751
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 7, 2021

NM/CT 850 Nuclear Medicine / CT Scanners

GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

ALL 50 STATES
Full report

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

Recall #:
87811
Lot/product code:
GTIN*00840682140775
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)