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Recalls affecting Wisconsin

Data last updated: September 8, 2026 at 1:13 PM UTC

16,929 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

▸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 Alive — Moringa 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. Braun — 0.9% 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 Value — Organic 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

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

▸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 Temptations — Chocolatey 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 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/virusAnnounced August 29, 2026

Martina — Mangoes

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)
NewestOldest
High riskLow riskAll
Wording
Class IIModerate risk
DrugRecalled July 2, 2019

Altaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-18

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-0424-2020
Lot/product code:
17200 7/19 17322 10/20 18026 1/21 18100 4/21 18236 9/21 19052 2/22
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

Altaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-35

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-0425-2020
Lot/product code:
17087 3/20 17088 3/20 17109 4/20 17110 4/20 17306 10/20 17307 10/20 17318 10/20 17323 10/20 18014 1/21 18045 2/21 18059 3/21 18063 3/21 18117 5/21 18134 5/21 18228 9/21 18261 10/21 19119 4/22 16207 8/19 16233 8/19 16250 9/19 16268 10/19 16301 11/19
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA, Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04

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-0457-2020
Lot/product code:
16250 09/19 17088 03/20 17307 10/20 17323 10/20 18014 1/21 18228 9/21 18261 10/21 19119 4/22
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-49

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-0433-2020
Lot/product code:
18033 2/20
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g, Rx only, Manufactured for Perrigo Minneapolis, MN 55427 NDC 0574-4250-35

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-0353-2020
Lot/product code:
Lot #: SAC, Exp 1/20; SLK, Exp 12/20
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-885-49

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-0369-2020
Lot/product code:
Lot #: 19137 05/22 19022 01/22
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

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-0412-2020
Lot/product code:
18043 2/20 18115 5/20 18300 12/20 18300 12/20 18116 5/20 18115 5/20 18044 2/20 18043 2/20
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, 15 mL, NDC 68770-104-15

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-0465-2020
Lot/product code:
17374 12/19 18196 8/20
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30

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-0451-2020
Lot/product code:
17208 7/21 17209 7/21 19001 1/23
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21

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-0449-2020
Lot/product code:
17255 8/20 17362 12/20 18089 4/21 18138 6/21 6/22/2018 18146 6/21 18210 8/21 18211 8/21 18272 11/21 18273 11/21 18276 11/21 16283 10/31/2019
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g

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-0486-2020
Lot/product code:
Lot #: QJD, Exp 10/19; RFK, Exp 6/20; SCB, Exp 3/21; TBI, Exp 2/22
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15

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-0441-2020
Lot/product code:
17205 7/19 17206 7/19 18003 1/20 18097 4/20 18166 7/20 18292 11/20 19106 4/21
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M Item # 563031654, Package Size 7.5 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54

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-0371-2020
Lot/product code:
Lot #: 17290; Exp 09/19
Recalling firm:
Altaire Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2019

OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05

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-0440-2020
Lot/product code:
17186 6/20 17345 11/20 19010 1/22 17041 2/2020 16217 8/19
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)
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

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 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

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

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 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)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250, LM-410320; Style LF: LF-410125, LF-410150,LF-410175,LF-410205,LF-410240,LF-410270,LF-410310,LF-410390,LF-410440,LF-410490,LF-410540,LF-410595,LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; style LX: LX-410145,LX-410175,LX-410195,LX-410225,LX-410255,LX-410290,LX-410330,LX-410365,LX-410405,LX-410455,LX-410515,LX-410570,LX-410625; Style ML: ML-410125,ML-410170,ML-410195,ML-410220,ML-410285; Style MM: MM-410160,MM-410185,MM-410215,MM-410245,MM-410280,MM-410320,MM-410360,MM-410400,MM-410450; Style MF: MF-410140MF-410165,MF-410195,MF-410225,MF-410255,MF-410295,MF-410335,MF-410375,MF-410420,MF-410470,MF-410525,MF-410580,MF-410640; Style MX: MX-410165,MX-410195,MX-410225,MX-410255,MX-410290,MX-410325,MX-410370,MX-410410,MX-410445,MX-410520,MX-410550,MX-410620,MX-410685; Style FL: FL-410140,FL-410190,FL-410220,FL-410250,FL-410320; Style FM:FM-410155,FM-410180,FM-410205,FM-410235,FM-410270,FM-410310,FM-410350,FM-410395,FM-410440,FM-410500,FM-410550,FM-410605,FM-410670; Style FF: FF-410160,FF-410185,FF-410220,FF-410255,FX-410290,FF-410335,FF-410375,FF-410425,FF-410475,FF-410535,FF-410595,FF-410655,FF-410740; Style FX: FX-410185FX-410215,FX-410245,FX-410280,FX-410315,FX-410360,FX-410410,FX-410450,FX-410495,FX-410560,FX-410615,FX-410690,FX-410775 These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
▸Full report

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

Recall #:
83500
Lot/product code:
ALL LOTS   Product Code/UDI  Style LL: LL-410135/10888628003170,LL-410180/10888628003187,LL-410210/10888628003194,LL-410240/10888628003200,LL-410300/10888628003217; Style LM: LM-410140/10888628003224,LM-410190/10888628003231,LM-410220/10888628003248,LM-410250/10888628003255,LM-410320/10888628003262; Style LF: LF-410125/10888628003057,LF-410150/10888628003064,LF-410175/10888628003071,LF-410205/10888628003088,LF-410240/10888628003095,LF-410270/10888628003101,LF-410310/10888628003118,LF-410390/10888628003125,LF-410440/10888628003132,LF-410490/10888628003149,LF-410540/10888628003156,LF-410595/10888628003163; Style LX: LX-410145/10888628003279,LX-410175/10888628003286,LX-410195/10888628003293,LX-410225/10888628003309,LX-410255/10888628003316,LX-410290/10888628003323,LX-410330/10888628003330,LX-410365/10888628003347,LX-410405/10888628003354,LX-410455/10888628003361,LX-410515/10888628003378,LX-410570/10888628003385,LX-410625/10888628003392; Style ML: ML-410125/10888628003538,ML-410170/10888628003545,ML-410195/10888628003552,ML-410220/10888628003569,ML-410285/10888628003576; Style MM: MM-410160 10888628003583,MM-410185/10888628003590,MM-410215/10888628003606,MM-410245/10888628003613,MM-410280/10888628003620,MM-410320/10888628003637,MM-410360/10888628003644,MM-410400/10888628003651,MM-410450/10888628003668; Style MF:MF-410140/10888628003408,MF-410165/10888628003415,MF-410195/10888628003422,MF-410225/10888628003439,MF-410255/10888628003446,MF-410295/10888628003453,MF-410335/10888628003460,MF-410375/10888628003477,MF-410420/10888628003484,MF-410470/10888628003491,MF-410525/10888628003507,MF-410580/10888628003514,MF-410640/10888628003521; Style MX:MX-410165/10888628003675,MX-410195/10888628003682,MX-410225/10888628003699,MX-410255/10888628003705,MX-410290/10888628003712,MX-410325/10888628003729,MX-410370/10888628003736,MX-410410/10888628003743,MX-410445/10888628003750,MX-410520/10888628003767,MX-410550/10888628003774,MX-410620/10888628003781,MX-410685/10888628003798;  Style FL: FL-410140/10888628002746,FL-410190/10888628002753,FL-410220/10888628002760,FL-410250/10888628002777,FL-410320/10888628002784; Style FM:FM-410155/10888628002791,FM-410180/10888628002807,FM-410205/10888628002814,FM-410235/10888628002821,FM-410270/10888628002838,FM-410310/10888628002845,FM-410350/10888628002852,FM-410395/10888628002869,FM-410440/10888628002876,FM-410500/10888628002883,FM-410550/10888628002890,FM-410605/10888628002906,FM-410670/10888628002913; Style FF: FF-410160/10888628002616,FF-410185/10888628002623,FF-410220/10888628002630,FF-410255/10888628002647,FF-410290/10888628002654,FF-410335/10888628002661,FF-410375/10888628002678,FF-410425/10888628002685,FF-410475/10888628002692,FF-410535/10888628002708,FF-410595/10888628002715,FF-410655/10888628002722,FF-410740/10888628002739;  Style FX: FX-410185/10888628002920,FX-410215/10888628002937,FX-410245/10888628002944,FX-410280/10888628002951,FX-410315/10888628002968,FX-410360/10888628002975,FX-410410/10888628002982,FX-410450/10888628002999,FX-410495/10888628003002,FX-410560/10888628003019,FX-410615/10888628003026,FX-410690/10888628003033,FX-410775/10888628003040;
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133FV: 133FV-11, 133FV-12, 133FV-13, 133FV-14, 133FV-15, 133FV-16; STYLE 133MV: 133MV-11, 133MV-12, 133MV-13, 133MV-14, 133MV-15, 133MV-16; STYLE 133LV: 133LV-11, 133LV-12, 133LV-13, 133LV-14, 133LV-15, 133LV-16; STYLE 133FX: 133FX-11 133FX-12 133FX-13 133FX-14 133FX-15 133FX-16 STYLE 133MX: 133MX-11, 133MX-12, 133MX-13, 133MX-14, 133MX-15, 133MX-16; STYLE 133SX: 133SX-11, 133SX-12, 133SX-13, 133SX-14, 133SX-15, 133SX-16; STYLE 133SV: 133SV-11, 133SV-12, 133SV-13, 133SV-14, 133SV-15, 133SV-16; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

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▸Full report

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

Recall #:
83500
Lot/product code:
ALL LOTS   Product Code/UDI STYLE 133FV: 133FV-11 10888628003927, 133FV-12 10888628003934, 133FV-13 10888628003941, 133FV-14 10888628003958, 133FV-15 10888628003965, 133FV-16 10888628003972;  STYLE 133MV: 133MV-11 10888628004108, 133MV-12 10888628004115, 133MV-13 10888628004122, 133MV-14 10888628004139, 133MV-15 10888628004146, 133MV-16 10888628004153;  STYLE 133LV: 133LV-11 10888628004047, 133LV-12 10888628004054, 133LV-13 10888628004061, 133LV-14 10888628004078, 133LV-15 10888628004085, 133LV-16 10888628004092;  STYLE 133FX:  133FX-11 10888628003989, 133FX-12 10888628003996, 133FX-13 10888628004009, 133FX-14 10888628004016, 133FX-15 10888628004023, 133FX-16 10888628004030;  STYLE 133MX: 133MX-11 10888628004160, 133MX-12 10888628004177, 133MX-13 10888628004184, 133MX-14 10888628004191, 133MX-15 10888628004207, 133MX-16 10888628004214;  STYLE 133SX: 133SX-11 10888628003804, 133SX-12 10888628003811, 133SX-13 10888628003828, 133SX-14 10888628003835, 133SX-15 10888628003842, 133SX-16 10888628003859;  STYLE 133SV: 133SV-11 10888628003866, 133SV-12 10888628003873, 133SV-13 10888628003880, 133SV-14 10888628003897, 133SV-15 10888628003903, 133SV-16 10888628003910;
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)