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Recalls affecting North Carolina

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

17,271 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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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 July 2, 2019

QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAsymphony SP instrument

QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against the sample ID prior to downstream application the incorrect tube may be selected and it could have the potential to lead to delayed results or incorrect patient reporting

ALL 50 STATES
Full report

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

Recall #:
83409
Lot/product code:
Software 5.0.3 Serial Numbers: 5786 13184 30000 34450 34886 35214 35455 35510 5943 13195 34023 34457 34887 35222 35456 35514 6037 13275 34040 34464 34891 35224 35457 35519 6263 13486 34045 34468 34892 35226 35458 35522 6325 13592 34068 34473 34893 35231 35459 35524 6529 13635 34907 34477 34894 35241 35460 35525 6531 13640 34080 34495 34896 35245 35462 35526 6828 13648 34081 34496 34897 35259 35463 35529 7188 13654 34083 34504 34901 35265 35464 35530 7232 13755 34086 34507 34902 35278 35465 35532 7295 13773 34112 34525 34701 35279 35466 35537 7297 13777 34116 34555 34914 35287 35467 35538 7340 13797 34123 34557 34923 35312 35468 35542 7349 13813 34124 34562 34931 35322 35469 35544 7409 13841 34129 34567 34951 35335 35471 35545 7432 13858 34143 34571 34977 35338 35472 35547 7480 13862 34152 34580 34981 35344 35473 35548 7725 13874 34153 34582 34986 35352 35474 35549 7973 13886 34161 34588 34988 35360 35475 35550 8049 13904 34181 34589 34366 34076 35476 35557 8052 13948 34184 34596 35001 35381 35477 35558 10109 14021 34192 34597 35011 35382 35478 35559 10198 14108 34204 34603 35013 35384 35479 35560 10389 14153 34221 34610 35014 35386 35497 35561 10630 14178 34229 34622 35015 35387 35481 35564 11177 14207 34237 34628 35024 35398 35482 35565 11392 14209 34245 34631 35030 35399 35483 35566 11417 14219 34247 34637 35033 35406 35484 35567 11431 14262 34252 34644 35042 35408 35485 35568 11590 14356 34265 34646 35045 35411 35486 35569 11609 14564 34268 34649 35061 35412 35487 35570 11938 14617 34269 34666 35070 35435 35488 35571 12010 14629 34281 34695 35075 35436 35489 35572 12052 14676 34297 34396 35079 35438 35490 35573 12053 14678 34322 34719 35083 35439 35491 35574 12106 14689 34338 34727 35086 35440 35492 35575 12175 14697 34342 34732 35094 35441 35493 35576 12203 14698 34343 34757 35097 35442 35495 35577 12275 14706 34349 34765 35115 35443 35496 47000 12304 14748 35362 34771 35118 35444 35480 12308 14764 34373 34787 35129 35445 35498 12435 14840 34392 34802 35132 35446 35499 12658 14856 35451 34813 35141 35447 35500 12758 14907 34401 34824 35179 35448 35501 12924 14941 34403 34825 35180 35449 35502 12979 14946 34410 34847 35182 35450 35503 13022 15028 34413 34856 35188 35000 35504 13135 15129 34421 34863 35202 35452 35505 13173 15226 34426 34880 35209 35453 35507 13183 15298 34447 34884 35213 35454 35508
Recalling firm:
Qiagen Sciences LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY 11931, NDC 59390-183-13

Not guaranteed to be germ-free

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-0417-2020
Lot/product code:
18008 1/20 8/13/2018 19050 2/22 3/18/2019 19105 4/22
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 3, 2019

Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System

When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.

ALL 50 STATES
Full report

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

Recall #:
83273
Lot/product code:
all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
Recalling firm:
Elekta Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

Flowers Bratwurst Buns 12 CT UPC 7 22500 40792

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1597-2019
Lot/product code:
Lot #111 Best By Date July 18, 2019
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

Dinner Rolls sold under the brand names of Laura Lynn UPC 86854 06669 0 & Wonder 12 CT UPC 72250 07421 6 24 CT UPC 72250 01169 3

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1599-2019
Lot/product code:
Laura Lynn Lot #180 Best By Date July 18, 2019; Wonder 12 & 24 CT - Lot #180 Best By Date July 18, 2019
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

BBQ Bread & Pull-A-Part BBQ Bread sold under the brand names of Flowers UPC 7 22500 40792, Ingles UPC 8 68540 15348 & Wonder UPC 7 22500 20923

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1596-2019
Lot/product code:
FLOWERS BBQ BREAD - Lot# 180 Best By Date July 18, 2019: Ingles - Lot #180 Best By Date July 18, 2019 & Wonder - Lot #180 Best By Date July 18, 2019
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

Hamburger Buns soled under the brand names of: 7-ELEVEN 8CT, UPC 52548 00660 0; BRAVO 8CT, UPC 33755 85868 8; CBC NATHANS 8CT, UPC 72250 09366 8; CLOVER VALLEY 8CT, UPC 70210 00759 5; FAMILY STYLE 8CT, UPC 72250 02473 0; FOOD DEPOT 8CT, UPC 72250 02440 2; GREAT VALUE 8CT, UPC 78742 22375 9; GRISSOM'S MILL 8CT, UPC 51933 26740 4; HITCHCOCK'S 8CT, UPC 70210 10337 2; HOME PRIDE 16CT, UPC 72250 00658 3; IDEAL 8CT, UPC 72250 02507 2; IGA 8CT, UPC 41270 02548 5; LAURA LYNN 8CT, UPC 86854 00780 8; MARKET PANTRY 8CT, UPC 85239 03163 6; MEMBERS MARK 8CT/3 PK, UPC 93968 01393 6; NATURAL GRAIN 8CT, UPC 73105 92058 0; OVEN FRESH 8CT, UPC 72250 02471 6; PIGGLY WIGGLY 8CT, UPC 41290 01317 2; PUBLIX 8CT, UPC 41415 30690 5; SE GROCERS 8CT, UPC 38259 10182 7; SEDANO'S 8CT, UPC 72250 00031 4; SUNBEAM 8CT, UPC 77633 06328 3; WM 8CT HAMBURGER BUNS (PAN PARA SANDWICH), UPC 78742 04868 0 & WONDER 8CT, UPC 72250 02109 8.

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1601-2019
Lot/product code:
IGA 8CT, Lot #111 & Lot #180, Best By Date July 19 2019 7-ELEVEN 8CT, BRAVO 8CT, CBC NATHANS 8CT, GRISSOM'S MILL 8CT, HITCHCOCK'S 8CT, HOME PRIDE 16CT, MEMBERS MARK 8CT/3 PK, NATURAL GRAIN 8CT, PIGGLY WIGGLY 8CT, SEDANO'S 8CT, WM 8CT HAMBURGER BUNS (PAN PARA SANDWICH) & WONDER 8CT - Lot #111, Best By Date July 18 2019; CLOVER VALLEY 8CT, FAMILY STYLE 8CT, MARKET PANTRY 8CT, OVEN FRESH 8CT, PUBLIX 8CT & SE GROCERS 8CT, Lot #111, Best By Date July 18, 2019 and Lot #180, Best By Date July 19 2019 FOOD DEPOT 8CT, GREAT VALUE 8CT, IDEAL 8CT, LAURA LYNN 8CT & SUNBEAM 8CT, Lot #180, Best By Date July 19 2019
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

Hot Dog Buns sold under the brand names of: CLOVER VALLEY 8CT UPC 70210 00760 1; FAMILY STYLE 8CT UPC 70210 01297 1; FLOWERS RESTAURANT 12CT UPC 70210 00640 6, UPC 70210 00649 9 & UPC 70210 00964 3; FOOD DEPOT 8CT UPC 72250 02439 6; GREAT VALUE 8CT UPC 78742 09728 2; IDEAL 8CT UPC 72250 02463 1; IGA 8CT UPC 41270 04244 4; LAURA LYNN 8CT UPC 86854 00784 6; MARLET PANTRY 8 CT UPC 85239 70133 1; NATURAL GRAIN 12CT UPC 73105 92059 7; OVEN FRESH 8CT UPC 72250 02438 9; PIGGLY WIGGLY 8CT UPC 41290 01313 4; PUBLIX 8CT UPC 41415 30790 2; SE GROCERS 8CT UPC 38259 10183 4; SUNBEAM 8CT UPC 77633 06374 0 & WONDER 8CT UPC 72250 02108 1

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1605-2019
Lot/product code:
CLOVER VALLEY, FAMILY STYLE, GREAT VALUE, IGA, MARLET PANTRY, OVEN FRESH, PIGGLY WIGGLY, PUBLIX, SE GROCERS & WONDER - Lot #111 & 180 Best By Date July 19 2019 FLOWERS RESTAURANT & NATURAL GRAIN - Lot #111 Best By Date July 18 2019 FOOD DEPOT, IDEAL, LAURA LYNN & SUNBEAM - Lot #180 Best By Date July 19 2019
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

Publix 12 CT Brown & Serve Rolls 12 CT UPC 41415 31190 9

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1598-2019
Lot/product code:
Lot #111 Best By Date July 18, 2019
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

NATURE'S OWN BUTTER HAMBURGER BUNS 8CT, UPC 72250 02313 9

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1602-2019
Lot/product code:
Lot#111, Best By Date July 18 2019
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

L'OVEN FRESH 8CT KAISER BUNS UPC 41498 11722 1

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1606-2019
Lot/product code:
Lot #111, Best By Date July 17 2019
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

WONDER HONEY HAMBURGER BUNS 8CT, UPC 72250 02112 8

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1603-2019
Lot/product code:
Lot#111, Best By Date July 18 2019
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

100% Whole Wheat Hamburger Buns sold under the brand names of: FLOWERS 8CT No UPC; GREAT VALUE UPC 78742 00800 4 & NATURES OWN 8CT UPC 72250 00398 8

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1604-2019
Lot/product code:
All have the lot code - Lot#111, Best By Date July 18 2019
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

Flowers Enriched Rolls UPC 70210 00686 4

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1600-2019
Lot/product code:
Lot #180 Best By Date July 18, 2019
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 9, 2019

Krystal 24 Sheet Sandwich Slider Buns

The products have the potential to contain small pieces of hard plastic introduced during production process.

Full report

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

Recall #:
F-1607-2019
Lot/product code:
Best By Date A JUL 11 07/06
Recalling firm:
FLOWERS FOODS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2019

Burstberry Laser Projection Series

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

ALL 50 STATES
Full report

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

Recall #:
83438
Lot/product code:
Burstberry
Recalling firm:
Gk Photonics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2019

Logolas Laser Projection Series

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

ALL 50 STATES
Full report

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

Recall #:
83438
Lot/product code:
Logolas Laser Projection Series
Recalling firm:
Gk Photonics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2019

Maxim Laser Projection Series

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

ALL 50 STATES
Full report

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

Recall #:
83438
Lot/product code:
Maxim Laser Projection Series
Recalling firm:
Gk Photonics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2019

Spectrum Laser Projection Series

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

ALL 50 STATES
Full report

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

Recall #:
83438
Lot/product code:
Spectrum Laser Projection Series
Recalling firm:
Gk Photonics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2019

Atom Laser Projection Series

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

ALL 50 STATES
Full report

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

Recall #:
83438
Lot/product code:
Atom Laser Projection Series
Recalling firm:
Gk Photonics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 10, 2019

ClubMax Laser Projection Series

The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

ALL 50 STATES
Full report

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

Recall #:
83438
Lot/product code:
ClubMax Laser Projection Series
Recalling firm:
Gk Photonics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 17, 2019

Autoject EI, REF AJ1310

There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107

Full report

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

Recall #:
83465
Lot/product code:
Lot/Unit Number: V14
Recalling firm:
Owen Mumford USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 17, 2019

Petfine Auto Injector, REF 3310VET

There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107

Full report

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

Recall #:
83465
Lot/product code:
batches V14.V976 and V14.W107
Recalling firm:
Owen Mumford USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 23, 2019

AggreGuide A-100 Instrument

The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay is 0 and the motor output required to achieve this RPM is also 0. Therefore, when the assay is run, the software applies 0 Volts to the motor and performs a 0 RPM assay. Because of this, there is no mixing of the blood with agonist and no moving of aggregates happens in front of the optical detectors. The resulting PAI is 0 and the result is displayed as Low.

ALL 50 STATES
Full report

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

Recall #:
90588
Lot/product code:
UDI-DI: 00856893004065; Software Versions 5.1 or 5.2; Serial Numbers Between xx0001 and xx0160
Recalling firm:
Aggredyne, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 23, 2019

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

The threads on posts stripping out when tensioned during application process.

ALL 50 STATES
Full report

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

Recall #:
92390
Lot/product code:
Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None
Recalling firm:
New Standard Device Inc
View official FDA record (opens in a new tab)