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Recalls affecting Alaska

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

16,296 recalls found
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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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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

▸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 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)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit 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

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)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust 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

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)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

There are lower than expected MICs for some gram negative species.

ALL 50 STATES
▸Full report

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

Recall #:
89416
Lot/product code:
Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16)
Recalling firm:
Remel Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

MODEL: X-RAY R/F SYSTEM FLUOROspeed X1

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

AKARAZCACOCTFLGAIAIDILINKSKYLAMAMIMNMOMSMTNCNENJNMNVNYOHORPARISCSDTNTXWAWV
▸Full report

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

Recall #:
89596
Lot/product code:
Model: FLUOROspeed X1 Generator Number: D150-40 Serial Numbers: MQ493E19C001 MQ493E3B8002 MQ493E3B9001 MQ493E1B4001 MQ493E1A1003 MQ493E1A3001 MQ493E1B5001 MQ493E3B8001 MQ493E1A5001 MQ493E1A1005 MQ493E1A2001 MQ493E1A4001 MQ493E1B6002 MQ493E1A8001 MQ493E1B4002 MQ493E1A4003 MQ493E1A4002 MQ493E1B6001 MQ493E1A2002 MQ493E1AC001 MQ493E1A1002 MQ493E19C002 MQ493E1A3003 MQ493E1A1004 MQ493E1A3002
Recalling firm:
Shimadzu Medical Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

MODEL: X-RAY TV SYSSTEM SONIALVISION safire17

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

AKARAZCACOCTFLGAIAIDILINKSKYLAMAMIMNMOMSMTNCNENJNMNVNYOHORPARISCSDTNTXWAWV
▸Full report

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

Recall #:
89596
Lot/product code:
Model: SonialVision safire: Generator Number: D150-40 Serial Numbers: 3M5249D41006 3M5249D2A004 3M5249D34001 3M5249D37006 3M5249D32012 3M5249D35002 3M5249D1C013 3M5249D31009 3M5249D29002 3M5249D33003 3M5249D2C004 3M5249D22013
Recalling firm:
Shimadzu Medical Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

MODEL: X-RAY TV SYSTEM SONIALVISION G4

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

AKARAZCACOCTFLGAIAIDILINKSKYLAMAMIMNMOMSMTNCNENJNMNVNYOHORPARISCSDTNTXWAWV
▸Full report

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

Recall #:
89596
Lot/product code:
Model: SonialVision G4 Generator Number: D150-40 Serial Numbers: 41C35166C003 41C3536B4001 41C351683006 41C3516B3001 41C35169C002 41C351699002 41C351699001 41C3517AA001 41C35169B002 41C351671001 41C3516A3001 41C351661002 41C351671007 41C351683003 41C351671005 41C35179B004 41C351674001 41C35168B002 41C3517AA002 41C351685004 41C35165B002 41C3535A5001 41C353597001 41C35359C001 41C351674004 41C351685003 41C35164C001 41C351641001 41C351671004 41C351679001 41C3535A1001 41C3535A3001 41C351664004 41C351679006 41C351684004 41C351674002 41C3535A2002 41C351669002 41C351646002 41C35164A001 41C35359C002 41C351692001 41C35168B001 41C351653004 41C351664002 41C351673004 41C351663002 41C35164B001 41C351683001 41C351683002 41C351799001 41C351686002 41C351646001 41C351679005 41C351693003 41C351665002 41C35179A001 41C35165A003 41C35168A003 41C35179B005 41C35179B003 41C351671006 41C351689001 41C351799002 41C351641002 41C351671002 41C351676002 41C35165A001 41C351643001 41C35165A002 41C351655001 41C351695003 41C351647001 41C35166A002 41C351693002 41C351695001 41C351664005 41C351673003 41C35166C001 41C3535AC001 41C35166A001 41C35168B003 41C35169C001 41C3517B1001 41C3518B4002 41C351653002 41C3518B4001 41C35168A004 41C351665003 41C351678002 41C351684001 41C351683005 41C351693001 41C351671003 41C35179C001 41C351677001 41C35167A001 41C35165B001 41C351676001 41C351662001 41C35168C002 41C351668002 41C351679004 41C351677002 41C35179B001 41C351684005 41C351692003 41C351653003 41C351666002 41C351682002 41C351685001 41C351677003 41C353597002 41C3517A2002 41C351661001 41C35168C005 41C35168A002 41C35169A001 41C351663001 41C351692004 41C35168C004 41C351664001 41C351681001 41C351651002 41C351684006 41C3535A2001 41C351679007 41C351799003 41C351667001 41C351678001 41C351683004 41C351681002 41C351656001 41C351655003 41C3516B3002 41C3517B3002 41C3518B5001 41C3518B5002 41C3518B7001 41C3536B7001 41C351656002 41C35166C002 41C35168C001 41C351679002 41C351651001 41C351686001 41C351692002 41C3517A2001 41C35168A001 41C35166A003 41C351665001 41C351659001 41C3535A3002 41C351653005 41C351684003 41C3517A3001 41C351685002 41C3517A3002 41C351688001 41C351666001 41C351673002 41C351793001 41C351641003 41C351682001 41C351673001 41C35169B001 41C351695002 41C351655002 41C351679003 41C35168C003 41C35179B002 41C3517B1002 41C3517B3001 41C351668001 41C351669001 41C351654002
Recalling firm:
Shimadzu Medical Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080

Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.

ALL 50 STATES
▸Full report

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

Recall #:
89389
Lot/product code:
Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)
Recalling firm:
Compass Health Brands (Corporate Office)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

Everest MI XT Inner Dilator, Catalog Number 5101-90167

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

ALL 50 STATES
▸Full report

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

Recall #:
89522
Lot/product code:
GTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK
Recalling firm:
K2M, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

ALL 50 STATES
▸Full report

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

Recall #:
89539
Lot/product code:
Part Number: I-114(S) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
Recalling firm:
Lusys Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

Everest MI XT Outer Dilator, Catalog Number 5101-90168

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

ALL 50 STATES
▸Full report

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

Recall #:
89522
Lot/product code:
GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN
Recalling firm:
K2M, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

ALL 50 STATES
▸Full report

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

Recall #:
89539
Lot/product code:
Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
Recalling firm:
Lusys Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

ALL 50 STATES
▸Full report

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

Recall #:
89539
Lot/product code:
Part Number: I-114(N) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
Recalling firm:
Lusys Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2022

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.

ALL 50 STATES
▸Full report

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

Recall #:
89524
Lot/product code:
All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
Recalling firm:
Carl Zeiss Meditec, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2022

Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032

Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

ALL 50 STATES
▸Full report

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

Recall #:
89592
Lot/product code:
Lot Numbers: 89648801 89648802 89648803 89648804 89648805 GTIN: 04546540608475 ****UPDATE 3/17/22: Lot Number: 89648802 UDI: " (01)04546540608475(17)261020(10)89648802 Removed from scope of Recall: 89648801 89648803 89648804 89648805
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 14, 2022

Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50

CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

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▸Full report

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

Recall #:
D-0387-2022
Lot/product code:
Lot #: 32451 Exp. 03/2022; 32532 Exp. 04/2022; 32552 Exp. 05/2022; 32701 32733 Exp. 10/2022; 32855 Exp. 02/2023; 32872 Exp. 03/2023.
Recalling firm:
Mayne Pharma Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2022

1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.

A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical intervention, or a revision surgery.

ALL 50 STATES
▸Full report

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

Recall #:
89515
Lot/product code:
All serial numbers of 1688 CCU, UDI: 07613327420081, with Software Revisions: 3.0.6, 4.0.13, and 4.0.18
Recalling firm:
Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2022

Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232

Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

ALL 50 STATES
▸Full report

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

Recall #:
89592
Lot/product code:
Lot Number: 89546202 GTIN: (01)04546540608536(17)261020(10)89546202
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2022

Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

ALL 50 STATES
▸Full report

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

Recall #:
89463
Lot/product code:
CP3 010421-3358 CP3 031419-3125 CP3 032921-3429 CP3 042020-3284 CP3 052219-3149 CP3 061521-3482 CP3 071720-3322 CP3 080218-3045 CP3 091218-3057 CP3 122118-3093 CP4 010621-3377 CP4 022619-3094 CP4 041620-3285 CP4 041719-3126 CP4 072020-3323 CP4 092518-3058 CP5 011221-3359 CP5 033121-3430 CP5 042219-3127 CP5 042220-3286 CP5 072320-3324 CP5 082318-3010 CP5 111418-3059 HP7 103018-3062
Recalling firm:
Lacrimedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2022

OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

ALL 50 STATES
▸Full report

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

Recall #:
89463
Lot/product code:
HP3 010819-3104 HP3 011321-3373 HP3 031519-3128 HP3 032521-3426 HP3 051419-3157 HP3 073118-3044 HP3 090921-3516 HP3 102618-3060 HP5 011221-3374 HP5 012519-3088 HP5 032019-3123 HP5 032621-3425 HP5 051519-3158 HP5 062521-3489 HP5 070819-3186 HP5 072221-3501 HP5 083018-3036 HP5 102918-3061 HP5 122120-3368 HP7 030821-3404 HP7 032119-3124 HP7 092019-3135 HP7 103018-3062
Recalling firm:
Lacrimedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2022

Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.

The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.

ALL 50 STATES
▸Full report

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

Recall #:
89499
Lot/product code:
Serial Numbers 550010 550011 550015 550016 550018 550019 550020 550021 550023 550024 550025 550026 550027 550028 550029 550030 550031 550032 550033 550034 550035 550036 550037 550038 550039 550040 550041 550042 550043 550044 550046 550047 550048 550049 550050 550051 550052 550055 550056 550057 550058 550059 550062 550063 550064 550065 550066 550067 550068 550069 550070 550071 550072 550073 550074 550075 550077 550079 550082 550083 550084 550085 550086 550087 550088 550089 550092 550093 550094 550095 550097 550099 550103 550109 550110 550111 550112 550114 550116 550117 550118 550119 550120 550122 550123 550124 550125 550126 550127 550129 550130 550131 550132 550133 550134 550135 550136 550137 550139 550140 550141 550142 550143 550144 550145 550146 550148 550149 550150 550152 550153 550154 550155 550157 550158 550159 550160 550161 550163 550164 550165 550166 550167 550168 550169 550170 550171 550172 550173 550174 550175 550177 550180 550181 550182 550184 550185 550186 550188 550190 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5… (truncated, 19936 characters total — see the official FDA record for the full value)
Recalling firm:
Siemens Medical Solutions USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2022

SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNENHNJNMNVNYOHOKORPAPRSCTNTXUTVAWAWIWV
▸Full report

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

Recall #:
89673
Lot/product code:
All serial numbers, limited to cases when: The SyncVision runs the current supported software version 4.2.x, AND The secondary modality (IntraSight IVUS) runs software version 5.x. Device Identifier (DI): 00845225012434
Recalling firm:
Volcano Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

BenchMark ULTRA and DISCOVERY ULTRA Instruments

Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
89727
Lot/product code:
Serial Numbers Less-Than-Or-Equal-To 322030
Recalling firm:
Ventana Medical Systems Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4304C Lot Numbers/UDI (GTIN, DI + PI): 0001414261 (01)10885403057052(17)220331(10)0001414261 0001414362 (01)10885403057052(17)220430(10)0001414362 0001415851 (01)10885403057052(17)220430(10)0001415851 0001415026 (01)10885403057052(17)220430(10)0001415026 0001421686 (01)10885403057052(17)220630(10)0001421686 0001424759 (01)10885403057052(17)220630(10)0001424759 0001426324 (01)10885403057052(17)220630(10)0001426324 0001428876 (01)10885403057052(17)220630(10)0001428876 0001432173 (01)10885403057052(17)220630(10)0001432173 0001434168 (01)10885403057052(17)220930(10)0001434168 0001438149 (01)10885403057052(17)221031(10)0001438149 0001438930 (01)10885403057052(17)221031(10)0001438930 0001441010 (01)10885403057052(17)221031(10)0001441010
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4301C Lot Numbers/UDI (GTIN, DI + PI): 0001410711 (01)10885403057038(17)220331(10)0001410711 0001411299 (01)10885403057038(17)220331(10)0001411299 0001411867 (01)10885403057038(17)220331(10)0001411867 0001414258 (01)10885403057038(17)220331(10)0001414258 0001414358 (01)10885403057038(17)220331(10)0001414358 0001414359 (01)10885403057038(17)220331(10)0001414359 0001415031 (01)10885403057038(17)220430(10)0001415031 0001415038 (01)10885403057038(17)220430(10)0001415038 0001415850 (01)10885403057038(17)220430(10)0001415850 0001415809 (01)10885403057038(17)220430(10)0001415809 0001417243 (01)10885403057038(17)220430(10)0001417243 0001417244 (01)10885403057038(17)220430(10)0001417244 0001417734 (01)10885403057038(17)220430(10)0001417734 0001418034 (01)10885403057038(17)220430(10)0001418034 0001418308 (01)10885403057038(17)220430(10)0001418308 0001418410 (01)10885403057038(17)220430(10)0001418410 0001421652 (01)10885403057038(17)220630(10)0001421652 0001421921 (01)10885403057038(17)220630(10)0001421921 0001422197 (01)10885403057038(17)220630(10)0001422197 0001422150 (01)10885403057038(17)220630(10)0001422150 0001422604 (01)10885403057038(17)220630(10)0001422604 0001425527 (01)10885403057038(17)220630(10)0001425527 0001425874 (01)10885403057038(17)220630(10)0001425874 0001426189 (01)10885403057038(17)220630(10)0001426189 0001426502 (01)10885403057038(17)220630(10)0001426502 0001427225 (01)10885403057038(17)220630(10)0001427225 0001427380 (01)10885403057038(17)220630(10)0001427380 0001429130 (01)10885403057038(17)220630(10)0001429130 0001429519 (01)10885403057038(17)220630(10)0001429519 0001430121 (01)10885403057038(17)220630(10)0001430121 0001430608 (01)10885403057038(17)220630(10)0001430608 0001431407 (01)10885403057038(17)220630(10)0001431407 0001431472 (01)10885403057038(17)220630(10)0001431472 0001432176 (01)10885403057038(17)220630(10)0001432176 0001432655 (01)10885403057038(17)220831(10)0001432655 0001433601 (01)10885403057038(17)220930(10)0001433601 0001433023 (01)10885403057038(17)220930(10)0001433023 0001434251 (01)10885403057038(17)220930(10)0001434251 0001434730 (01)10885403057038(17)220930(10)0001434730 0001436141 (01)10885403057038(17)220930(10)0001436141 0001437469 (01)10885403057038(17)221031(10)0001437469 0001437660 (01)10885403057038(17)221031(10)0001437660 0001437658 (01)10885403057038(17)221031(10)0001437658 0001437768 (01)10885403057038(17)221031(10)0001437768
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.

In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing incorrectly-configured reference range values

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▸Full report

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

Recall #:
89645
Lot/product code:
Software versions up to and including v2.59.3. Serial Number UDI (US): Q100 +B787OLOU10/$$+7Q-100G Q121 +B787OLOU10/$$+7Q-121J Q138 +B787OLOU10/$$+7Q-138R Q145 +B787OLOU10/$$+7Q-145P Q146 +B787OLOU10/$$+7Q-146Q Q167 +B787OLOU10/$$+7Q-167T Q212 +B787OLOU10/$$+7Q-212K Q213 +B787OLOU10/$$+7Q-213L Q225 +B787OLOU10/$$+7Q-225O Q228 +B787OLOU10/$$+7Q-228R Q241 +B787OLOU10/$$+7Q-241M Q258 +B787OLOU10/$$+7Q-258U Q264 +B787OLOU10/$$+7Q-264R Q270 +B787OLOU10/$$+7Q-270O Q273 +B787OLOU10/$$+7Q-273R Q275 +B787OLOU10/$$+7Q-275T Q277 +B787OLOU10/$$+7Q-277V Q283 +B787OLOU10/$$+7Q-283S Q303 +B787OLOU10/$$+7Q-303L Q331 +B787OLOU10/$$+7Q-331M Q332 +B787OLOU10/$$+7Q-332N Q334 +B787OLOU10/$$+7Q-334P Q338 +B787OLOU10/$$+7Q-338T Q341 +B787OLOU10/$$+7Q-341N Q347 +B787OLOU10/$$+7Q-347T Q352 +B787OLOU10/$$+7Q-352P Q363 +B787OLOU10/$$+7Q-363R Q365 +B787OLOU10/$$+7Q-365T Q372 +B787OLOU10/$$+7Q-372R Q375 +B787OLOU10/$$+7Q-375U Q380 +B787OLOU10/$$+7Q-380Q Q383 +B787OLOU10/$$+7Q-383T Q384 +B787OLOU10/$$+7Q-384U Q387 +B787OLOU10/$$+7Q-387X Q391 +B787OLOU10/$$+7Q-391S Q393 +B787OLOU10/$$+7Q-393U Q394 +B787OLOU10/$$+7Q-394V Q398 +B787OLOU10/$$+7Q-398Z Q400 +B787OLOU10/$$+7Q-400J Q403 +B787OLOU10/$$+7Q-403M Q411 +B787OLOU10/$$+7Q-411L Q417 +B787OLOU10/$$+7Q-417R Q418 +B787OLOU10/$$+7Q-418S Q420 +B787OLOU10/$$+7Q-420L Q424 +B787OLOU10/$$+7Q-424P Q427 +B787OLOU10/$$+7Q-427S Q436 +B787OLOU10/$$+7Q-436S Q437 +B787OLOU10/$$+7Q-437T Q440 +B787OLOU10/$$+7Q-440N Q442 +B787OLOU10/$$+7Q-442P Q451 +B787OLOU10/$$+7Q-451P Q452 +B787OLOU10/$$+7Q-452Q Q462 +B787OLOU10/$$+7Q-462R Q463 +B787OLOU10/$$+7Q-463S Q465 +B787OLOU10/$$+7Q-465U Q467 +B787OLOU10/$$+7Q-467W Q468 +B787OLOU10/$$+7Q-468X Q469 +B787OLOU10/$$+7Q-469Y Q470 +B787OLOU10/$$+7Q-470Q Q472 +B787OLOU10/$$+7Q-472S Q489 +B787OLOU10/$$+7Q-489- Q496 +B787OLOU10/$$+7Q-496Y Q499 +B787OLOU10/$$+7Q-499. Q510 +B787OLOU10/$$+7Q-510L Q511 +B787OLOU10/$$+7Q-511M Q512 +B787OLOU10/$$+7Q-512N Q513 +B787OLOU10/$$+7Q-513O Q515 +B787OLOU10/$$+7Q-515Q Q520 +B787OLOU10/$$+7Q-520M Q524 +B787OLOU10/$$+7Q-524Q Q527 +B787OLOU10/$$+7Q-527T Q532 +B787OLOU10/$$+7Q-532P Q534 +B787OLOU10/$$+7Q-534R Q541 +B787OLOU10/$$+7Q-541P Q543 +B787OLOU10/$$+7Q-543R Q551 +B787OLOU10/$$+7Q-551Q Q552 +B787OLOU10/$$+7Q-552R Q557 +B787OLOU10/$$+7Q-557W Q559 +B787OLOU10/$$+7Q-559Y Q561 +B787OLOU10/$$+7Q-561R Q565 +B787OLOU10/$$+7Q-565V Q569 +B787OLOU10/$$+7Q-569Z Q570 +B787OLOU10/$$+7Q-570R Q571 +B787OLOU10/$$+7Q-571S Q577 +B787OLOU10/$$+7Q-577Y Q581 +B787OLOU10/$$+7Q-581T Q586 +B787OLOU10/$$+7Q-586Y Q594 +B787OLOU10/$$+7Q-594X Q614 +B787OLOU10/$$+7Q-614Q Q620 +B787OLOU10/$$+7Q-620N Q624 +B787OLOU10/$$+7Q-624R Q633 +B787OLOU10/$$+7Q-633R Q634 +B787OLOU10/$$+7Q-634S Q638 +B787OLOU10/$$+7Q-638W Q640 +B787OLOU10/$$+7Q-640P Q659 +B787OLOU10/$$+7Q-659Z Q661 +B787OLOU10/$$+7Q-661S Q664 +B787OLOU10/$$+7Q-664V Q667 +B787OLOU10/$$+7Q-667Y Q668 +B787OLOU10/$$+7Q-668Z Q669 +B787OLOU10/$$+7Q-669- Q673 +B787OLOU10/$$+7Q-673V Q676 +B787OLOU10/$$+7Q-676Y Q678 +B787OLOU10/$$+7Q-678- Q679 +B787OLOU10/$$+7Q-679. Q681 +B787OLOU10/$$+7Q-681U Q686 +B787OLOU10/$$+7Q-686Z Q687 +B787OLOU10/$$+7Q-687- Q96 +B787OLOU10/$$+7Q-096U. Serial Number UDI (OUS) Q113 +B787OLOE10/$$+7Q-1134 Q140 +B787OLOE10/$$+7Q-1404 Q142 +B787OLOE10/$$+7Q-1426 Q157 +B787OLOE10/$$+7Q-157C Q159 +B787OLOE10/$$+7Q-159E Q162 +B787OLOE10/$$+7Q-1628 Q166 +B787OLOE10/$$+7Q-166C Q170 +B787OLOE10/$$+7Q-1707 Q175 +B787OLOE10/$$+7Q-175C Q176 +B787OLOE10/$$+7Q-176D Q177 +B787OLOE10/$$+7Q-177E Q179 +B787OLOE10/$$+7Q-179G Q180 +B787OLOE10/$$+7Q-1808 Q189 +B787OLOE10/$$+7Q-189H Q191 +B787OLOE10/$$+7Q-191A Q204 +B787OLOE10/$$+7Q-2045 Q205 +B787OLOE10/$$+7Q-2056 Q206 +B787OLOE10/$$+7Q-2067 Q208 +B787OLOE10/$$+7Q-2089 Q209 +B787OLOU10/$$+7Q-209Q Q210 +B787OLOE10/$$+7Q-2102 Q216 +B787OLOE10/$$+7Q-2168 Q220 +B787OLOE10/$$+7Q-2203 Q221 +B787OLOE10/$$+7Q-2214 Q223 +B787OLOE10/$$+7Q-2236 Q224 +B787OLOE10/$$+7Q-2247 Q227 +B787OLOE10/$$+7Q-227A Q232 +B787OLOE10/$$+7Q-2326 Q233 +B787OLOE10/$$+7Q-2337 Q234 +B787OLOE10/$$+7Q-2348 Q236 +B787OLOE10/$$+7Q-236A Q237 +B787OLOE10/$$+7Q-237B Q243 +B787OLOE10/$$+7Q-2438 Q245 +B787OLOE10/$$+7Q-245A Q246 +B787OLOE10/$$+7Q-246B Q247 +B787OLOU10/$$+7Q-247S Q249 +B787OLOE10/$$+7Q-249E Q250 +B787OLOE10/$$+7Q-2506 Q251 +B787OLOE10/$$+7Q-2517 Q255 +B787OLOE10/$$+7Q-255B Q256 +B787OLOE10/$$+7Q-256C Q260 +B787OLOE10/$$+7Q-2607 Q261 +B787OLOE10/$$+7Q-2618 Q262 +B787OLOE10/$$+7Q-2629 Q263 +B787OLOE10/$$+7Q-263A Q265 +B787OLOE10/$$+7Q-265C Q267 +B787OLOE10/$$+7Q-267E Q268 +B787OLOE10/$$+7Q-268F Q271 +B787OLOE10/$$+7Q-2719 Q272 +B787OLOE10/$$+7Q-272A Q274 +B787OLOE10/$$+7Q-274C Q276 +B787OLOE10/$$+7Q-276E Q278 +B787OLOE10/$$+7Q-278G Q279 +B787OLOE10/$$+7Q-279H Q280 +B787OLOE10/$$+7Q-2809 Q281 +B787OLOE10/$$+7Q-281A Q282 +B787OLOE10/$$+7Q-282B Q284 +B787OLOE10/$$+7Q-284D Q285 +B787OLOE10/$$+7Q-285E Q286 +B787OLOE10/$$+7Q-286F Q287 +B787OLOE10/$$+7Q-287G Q288 +B787OLOE10/$$+7Q-288H Q289 +B787OLOE10/$$+7Q-289I Q290 +B787OLOE10/$$+7Q-290A Q291 +B787OLOE10/$$+7Q-291B Q293 +B787OLOE10/$$+7Q-293D Q… (truncated, 9111 characters total — see the official FDA record for the full value)
Recalling firm:
SIGHT DIAGNOSTICS LTD
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4301CDF Lot Numbers/UDI (GTIN, DI + PI): 0001433537 (01)10885403231810(17)260831(10)0001433537 0001437269 (01)10885403231810(17)260930(10)0001437269
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

LUMBAR PUNCTURE TRAY ADULT 18G X 3.5

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4303C Lot Numbers/UDI (GTIN, DI + PI): 0001411294 (01)10885403057021(17)220331(10)0001411294 0001414259 (01)10885403057021(17)220331(10)0001414259 0001414361 (01)10885403057021(17)220331(10)0001414361 0001415025 (01)10885403057021(17)220430(10)0001415025 0001417547 (01)10885403057021(17)220430(10)0001417547 0001422377 (01)10885403057021(17)220630(10)0001422377 0001425366 (01)10885403057021(17)220630(10)0001425366 0001426588 (01)10885403057021(17)220630(10)0001426588 0001428500 (01)10885403057021(17)220630(10)0001428500 0001431408 (01)10885403057021(17)220630(10)0001431408 0001433267 (01)10885403057021(17)220831(10)0001433267 0001433868 (01)10885403057021(17)220930(10)0001433868
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)