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Recalls affecting Alaska

Data last updated: September 9, 2026 at 1:18 PM UTC

16,261 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 Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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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/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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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/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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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

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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)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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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)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

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

Undeclared milk

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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)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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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/virusAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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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)
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UnclassifiedRisk not yet known
Medical deviceRecalled January 30, 2020

Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.

ALL 50 STATES
▸Full report

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

Recall #:
84944
Lot/product code:
Product Number 29901; All Serial Numbers;   Known Model Numbers:  a. Model Number 29901, GTIN (Lot Numbers): 00643169369030 (JVD000243P),  00643169369030 (JVD000246P),  00643169369030 (JVD000248P),  00643169369030 (JVD000249P),  00643169369030 (JVD000250P),  00643169369030 (JVD000252P),  00643169369030 (JVD000270P),  00643169369030 (JVD000274P),  00643169369030 (JVD000277P),  00643169369030 (JVD000280P),  00643169369030 (JVD000281P),  00643169369030 (JVD000302P),  00643169369030 (JVD000303P),  00643169167087 (JVD000304P),  00643169369030 (JVD000312P),  00643169369030 (JVD000315P),  00643169167087 (JVD000317P),  00643169369030 (JVD000323P),  00643169369030 (JVD000325P),  00643169369030 (JVD000327P),  00643169369030 (JVD000328P),  00643169369030 (JVD000329P),  00643169369030 (JVD000335P),  00643169369030 (JVD000340P),  00643169369030 (JVD000345P),  00643169369030 (JVD000349P),  00643169369030 (JVD000365P),  00643169369030 (JVD000366P),  00643169369030 (JVD000375P),  00643169369030 (JVD000380P),  00643169369030 (JVD000396P),  00643169369030 (JVD000400P),  00643169369030 (JVD000403P),  00643169369030 (JVD000406P),  00643169369030 (JVD000416P),  00643169369030 (JVD000422P),  00643169369030 (JVD000423P),  00643169369030 (JVD000427P),  00643169369030 (JVD000429P),  00643169369030 (JVD000431P),  00643169369030 (JVD000433P),  00643169369030 (JVD000435P),  00643169369030 (JVD000436P),  00643169369030 (JVD000438P),  00643169369030 (JVD000440P),  00643169369030 (JVD000441P),  00643169369030 (JVD000442P),  00643169369030 (JVD000443P),  00643169369030 (JVD000456P),  00643169369030 (JVD000462P),  00643169225732 (JVD000463P),  00643169369030 (JVD000464P),  00643169369030 (JVD000465P),  00643169369030 (JVD000466P),  00643169369030 (JVD000467P),  00643169369030 (JVD000468P),  00643169369030 (JVD000469P),  00643169369030 (JVD000470P),  00643169369030 (JVD000472P),  00643169225732 (JVD000473P),  00643169225732 (JVD000474P),  00643169369030 (JVD000475P),  00643169369030 (JVD000477P),  00643169369030 (JVD000483P),  00643169225732 (JVD000484P),  00643169369030 (JVD000485P),  00643169369030 (JVD000486P),  00643169225732 (JVD000489P),  00643169369030 (JVD000490P),  00643169369030 (JVD000491P),  00643169369030 (JVD000492P),  00643169369030 (JVD000494P),  00643169369030 (JVD000495P),  00643169369030 (JVD000496P),  00643169369030 (JVD000498P),  00643169369030 (JVD000499P),  00643169369030 (JVD000500P),  00643169225732 (JVD000501P),  00643169369030 (JVD000502P),  00643169369030 (JVD000503P),  00643169369030 (JVD000505P),  00643169369030 (JVD000506P),  00643169369030 (JVD000507P),  00643169369030 (JVD000508P),  00643169369030 (JVD000509P),  00643169369030 (JVD000510P),  00643169369030 (JVD000512P),  00643169369030 (JVD000513P),  00643169369030 (JVD000514P),  00643169369030 (JVD000515P),  00643169369030 (JVD000516P),  00643169369030 (JVD000517P),  00643169369030 (JVD000520P),  00643169225732 (JVD000523P),  00643169369030 (JVD000524P),  00643169225732 (JVD000525P),  00643169369030 (JVD000526P),  00643169369030 (JVD000531P),  00643169369030 (JVD000532P),  00643169369030 (JVD001001P),  00643169225732 (JVD001002P),  00643169369030 (JVD001003P),  00643169369030 (JVD001005P),  00643169369030 (JVD001006P),  00643169369030 (JVD001007P),  00643169225732 (JVD001008P),  00643169369030 (JVD001009P),  00643169369030 (JVD001011P),  00643169369030 (JVD001013P),  00643169225732 (JVD001016P),  00643169369030 (JVD001017P),  00643169369030 (JVD001018P),  00643169369030 (JVD001019P),  00643169369030 (JVD001020P),  00643169369030 (JVD001021P),  00643169369030 (JVD001022P),  00643169369030 (JVD001023P),  00643169369030 (JVD001025P),  00643169369030 (JVD001030P),  00643169167087 (JVD001031P),  00643169369030 (JVD001033P),  00643169369030 (JVD001034P),  00643169369030 (JVD001035P),  00643169369030 (JVD001036P),  00643169369030 (JVD001037P),  00643169369030 (JVD001039P),  00643169369030 (JVD001040P),  00643169369030 (JVD001041P),  00643169369030 (JVD001042P),  00643169369030 (JVD001043P),  00643169369030 (JVD001044P),  00643169369030 (JVD001045P),  00643169369030 (JVD001046P),  00643169369030 (JVD001047P),  00643169369030 (JVD001048P),  00643169369030 (JVD001049P),  00643169369030 (JVD001050P),  00643169369030 (JVD001051P),  00643169369030 (JVD001052P),  00643169369030 (JVD001053P),  00643169369030 (JVD001054P),  00643169369030 (JVD001055P),  00643169369030 (JVD001056P),  00643169369030 (JVD001058P),  00643169369030 (JVD001059P),  00643169369030 (JVD001060P),  00643169369030 (JVD001061P),  00643169225732 (JVD001063P),  00643169225732 (JVD001064P),  00643169225732 (JVD001065P),  00643169369030 (JVD001066P),  00643169225732 (JVD001067P),  00643169369030 (JVD001070P),  00643169369030 (JVD001071P),  00643169369030 (JVD001072P),  00643169369030 (JVD001073P),  00643169369030 (JVD001074P),  00643169369030 (JVD001075P),  00643169369030 (JVD001076P),  00643169369030 (JVD001077P),  00643169369030 (JVD001078P),  00643169369030 (JVD001079P),  00643169369030 (JVD001080P), … (truncated, 166353 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 4, 2020

CareFusion Alaris Pump Module, Model 8100

1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders

ALL 50 STATES
▸Full report

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

Recall #:
84579
Lot/product code:
Software versions 12.1.0, and 9.33 and prior
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 4, 2020

CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)

1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders

ALL 50 STATES
▸Full report

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

Recall #:
84579
Lot/product code:
Model 8000, software versions 9.5 and prior; Model 8015, software versions 12.1.0, and 9.33 and prior
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 4, 2020

VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.

False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENJNMNVNYOHOKORPARISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
84723
Lot/product code:
Model 3000 version 1.6
Recalling firm:
LivaNova USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 4, 2020

CareFusion Alaris Syringe Module, Model 8110

1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders

ALL 50 STATES
▸Full report

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

Recall #:
84579
Lot/product code:
Software versions 12.1.0, and 9.33 and prior
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 4, 2020

CareFusion Alaris PCA Module, Model 8120

1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders

ALL 50 STATES
▸Full report

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

Recall #:
84579
Lot/product code:
Software versions 12.1.0, and 9.33 and prior
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 10, 2020

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format

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

Recall #:
85068
Lot/product code:
McKesson Cardiology Software Versions: 13.2.1 HF1, 13.2.1 HF2, 14.0, 14.0 HF1, 14.0 HF2;   Change Healthcare Software Versions: 14.1.1, 14.2
Recalling firm:
CHANGE HEALTHCARE CANADA COMPANY
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2020

Imager II 5F Angiographic Catheters, 5 units per package.

Potential for tip detachment of Imager II 5F Angiographic Catheters

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

Recall #:
84886
Lot/product code:
All lots of the following: 1 Material Number (UPN) Outer Package M001314041, Material Number (UPN) Inner Package M001314040 2 Material Number (UPN) Outer Package M001314051, Material Number (UPN) Inner Package M001314050 3 Material Number (UPN) Outer Package M001314061, Material Number (UPN) Inner Package M001314060 4 Material Number (UPN) Outer Package M001314071, Material Number (UPN) Inner Package M001314070 5 Material Number (UPN) Outer Package M001314081, Material Number (UPN) Inner Package M001314080 6 Material Number (UPN) Outer Package M001314091, Material Number (UPN) Inner Package M001314090 7 Material Number (UPN) Outer Package M001314101, Material Number (UPN) Inner Package M001314100 8 Material Number (UPN) Outer Package M001314111, Material Number (UPN) Inner Package M001314110 9 Material Number (UPN) Outer Package M001314121, Material Number (UPN) Inner Package M001314120 10 Material Number (UPN) Outer Package M001314131, Material Number (UPN) Inner Package M001314130 11 Material Number (UPN) Outer Package M001314141, Material Number (UPN) Inner Package M001314140 12 Material Number (UPN) Outer Package M001314151, Material Number (UPN) Inner Package M001314150 13 Material Number (UPN) Outer Package M001314161, Material Number (UPN) Inner Package M001314160 14 Material Number (UPN) Outer Package M001314171, Material Number (UPN) Inner Package M001314170 15 Material Number (UPN) Outer Package M001314181, Material Number (UPN) Inner Package M001314180 16 Material Number (UPN) Outer Package M001314191, Material Number (UPN) Inner Package M001314190 17 Material Number (UPN) Outer Package M001314211, Material Number (UPN) Inner Package M001314210 18 Material Number (UPN) Outer Package M001314221, Material Number (UPN) Inner Package M001314220 19 Material Number (UPN) Outer Package M001314231, Material Number (UPN) Inner Package M001314230 20 Material Number (UPN) Outer Package M001314241, Material Number (UPN) Inner Package M001314240 21 Material Number (UPN) Outer Package M001314251, Material Number (UPN) Inner Package M001314250 22 Material Number (UPN) Outer Package M001314261, Material Number (UPN) Inner Package M001314260 23 Material Number (UPN) Outer Package M001314271, Material Number (UPN) Inner Package M001314270 24 Material Number (UPN) Outer Package M001314301, Material Number (UPN) Inner Package M001314300 25 Material Number (UPN) Outer Package M001314311, Material Number (UPN) Inner Package M001314310 26 Material Number (UPN) Outer Package M001314321, Material Number (UPN) Inner Package M001314320 27 Material Number (UPN) Outer Package M001314331, Material Number (UPN) Inner Package M001314330 28 Material Number (UPN) Outer Package M001314341, Material Number (UPN) Inner Package M001314340 29 Material Number (UPN) Outer Package M001314351, Material Number (UPN) Inner Package M001314350 30 Material Number (UPN) Outer Package M001314361, Material Number (UPN) Inner Package M001314360 31 Material Number (UPN) Outer Package M001314371, Material Number (UPN) Inner Package M001314370 32 Material Number (UPN) Outer Package M001314391, Material Number (UPN) Inner Package M001314390 33 Material Number (UPN) Outer Package M001314401, Material Number (UPN) Inner Package M001314400 34 Material Number (UPN) Outer Package M001314411, Material Number (UPN) Inner Package M001314410 35 Material Number (UPN) Outer Package M001314421, Material Number (UPN) Inner Package M001314420 36 Material Number (UPN) Outer Package M001314431, Material Number (UPN) Inner Package M001314430 37 Material Number (UPN) Outer Package M001314441, Material Number (UPN) Inner Package M001314440 38 Material Number (UPN) Outer Package M001314451, Material Number (UPN) Inner Package M001314450 39 Material Number (UPN) Outer Package M001314461, Material Number (UPN) Inner Package M001314460 40 Material Number (UPN) Outer Package M001314471, Material Number (UPN) Inner Package M001314470 41 Material Number (UPN) Outer Package M001314481, Material Number (UPN) Inner Package M001314480 42 Material Number (UPN) Outer Package M001314501, Material Number (UPN) Inner Package M001314500 43 Material Number (UPN) Outer Package M001314521, Material Number (UPN) Inner Package M001314520 44 Material Number (UPN) Outer Package M001314531, Material Number (UPN) Inner Package M001314530 45 Material Number (UPN) Outer Package M001314541, Material Number (UPN) Inner Package M001314540 46 Material Number (UPN) Outer Package M001314551, Material Number (UPN) Inner Package M001314550 47 Material Number (UPN) Outer Package M001314561, Material Number (UPN) Inner Package M001314560 48 Material Number (UPN) Outer Package M001314571, Material Number (UPN) Inner Package M001314570 49 Material Number (UPN) Outer Package M001314581, Material Number (UPN) Inner Package M001314580 50 Material Number (UPN) Outer Package M001314591, Material Number (UPN) Inner Package M001314590 51 Material Number (UPN) Outer Package M001314621, Material Number (UPN) Inner Pac… (truncated, 9430 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2020

Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.

The firm received reports of a number of broken latches on the floorsitter.

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

Recall #:
85086
Lot/product code:
LEC/178486 to LEC/206637; LEC/189092 to LEC/204087; Firefly Splashy-All codes beginning 176; Firefly GoTo Seat-All codes beginning 167 and including letter F in code.
Recalling firm:
James Leckey Design Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2020

Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.

The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

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

Recall #:
85030
Lot/product code:
Lot 306UL
Recalling firm:
Randox Laboratories Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2020

Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

During an FDA audit, it was discovered that the product was not properly registered with FDA.

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

Recall #:
85034
Lot/product code:
1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919
Recalling firm:
Gentell, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2020

Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

During an FDA audit, it was discovered that the product was not properly registered with FDA.

ALL 50 STATES
▸Full report

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

Recall #:
85034
Lot/product code:
1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1121419 1124919
Recalling firm:
Gentell, Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2020

Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

During an FDA audit, it was discovered that the product was not properly registered with FDA.

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

Recall #:
85034
Lot/product code:
1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919
Recalling firm:
Gentell, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2020

Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

During an FDA audit, it was discovered that the product was not properly registered with FDA.

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

Recall #:
85034
Lot/product code:
1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919
Recalling firm:
Gentell, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2020

Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

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

Recall #:
85309
Lot/product code:
Serial Numbers: A5B1642006, A1B17X2004, A5A1612005, A5B1772009, B5B1962002, A3A1522004, A7B16Y2001, A3A1712011, A5B1792010, A5A1532002, A1A1612003, A3A15Z2007, A5A1552003, A5B16Y2007, A3B1862016, A3B1812013, A3A1662009, A9A16X2004, BTA1922001, A3B1842015, AOB1882001, BMB1942001, AOB1892002, A5B1472001, A5B17Z2011, A3A14X2002, A5A1592004, A3A17Z2012, A5C1832012, A5B16Z2008, A1A1582002, A9A1582002, A1A14X2001, A3A1512003, A7C1812002, ABC18X2002, A3A1592005, UTC14Y2008, A3A15X2006, B5B1942001, A3A1682010, A1C18Z2005, A9A1662003, A3A1492001, A3B1822014, A3A1622008
Recalling firm:
Canon Medical System, USA, INC.
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UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2020

Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

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

Recall #:
85309
Lot/product code:
Serial Numbers: B8B1972001, A9A1592001, A3A14Z2001, AEB1812002, A1B1552001, A9C18Y2007, A3E1922002, B5B1952001, A9C1822006, A9B1622002, A9B1722003, A5C1622001, B3B19Y2001, A1D1772003, B1B19X2001, A5C16Y2002, A9C1822005, A1E1862008, A1D1752002, A1E1832004, A1E1852005, A1E1852006, A5E1862003, AEA17X2001
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2020

Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

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

Recall #:
85309
Lot/product code:
Serial Numbers: AGB1692005, AGB17Z2010, AGA1552003, AGB17Y2009, AGB1682004, AGA1492002, AGC1822012, A5C1922001, AGB1712007, AGC1952014, AGB1482001, AGC1822011, BGB1992001, AGC18X2013, AGB16Z2006
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 4, 2020

RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.

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

Recall #:
85255
Lot/product code:
Systems with software versions: 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.7.6.7 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 or 9.1.0.933
Recalling firm:
RAYSEARCH LABORATORIES AB
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UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2020

Philips V60 Ventilators with Power Management PCBA part number 1055906

Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVIVTWAWIWVWY
▸Full report

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

Recall #:
85113
Lot/product code:
Serial Numbers: 100002908 to 100027093; 100027096 to 100085389; 100085399 to 100109746; 100109868 to 201003390; 201003392 to 201010952
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 6, 2020

AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.

The UDI on the device label indicates incorrect manufacturer.

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

Recall #:
85094
Lot/product code:
Model Number 4BCPPB-3XCZ0002 (Lot Numbers PPB1155 - PPB1174, PPB1194 - PPB1213, PPB1222 - PPB1241, PPB1265 - PPB1284, PPB1292 - PPB1311, PPB1346 - PPB1365, PPB1375 - PPB1394, PPB1451 - PPB1466, PPB1477 - PPB1496, PPB1508 - PPB1527);   Model Number 4BCPPB-CCZ0008, Lot Number PPB1446 - PPB1449;  Model Number 4BCPPB-BCZ0009, Lot Number PPB1541 - PPB1542
Recalling firm:
Linet Americas
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UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24755842
Recalling firm:
Boston Scientific
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UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24484631, 24494135, 24494288, 24533782, 24584655, 24617736, 24625474, 24665994, 24723912
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24755840
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
▸Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24423656, 24423820, 24424087, 24427952, 24427959, 24428330, 24430010, 24437882, 24440182, 24440998, 24444952, 24446611, 24447516, 24447658, 24447722, 24447735, 24451828, 24452126, 24452132, 24452266, 24454238, 24455297, 24455381, 24455732, 24460452, 24460458, 24466032, 24487805, 24493956, 24494611, 24498583, 24498730, 24498732, 24499924, 24501439, 24506583, 24563429, 24563891, 24564727, 24564729, 24569684, 24570465, 24571203, 24579763, 24599358, 24609013, 24609991, 24614307, 24615296, 24620493, 24621357, 24621789, 24622541, 24623111, 24623117, 24623321, 24623461, 24623472, 24640257, 24661651, 24662199, 24663152, 24663562, 24663570, 24665001, 24665005, 24665100, 24665108, 24665990, 24666401, 24670677, 24672232, 24672553, 24678045, 24678047, 24681044, 24699798, 24700605, 24702016, 24708365, 24708371, 24709540, 24709550, 24710261, 24716280, 24716623, 24719303, 24723783, 24724284, 24732445, 24732731, 24738283, 24751717, 24756104, 24758578, 24763250, 24765356, 24766287, 24766401, 24772737, 24773528
Recalling firm:
Boston Scientific
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UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
▸Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24749818, 24913418
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)