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Recalls affecting California

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

17,393 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

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

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
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High riskLow riskAll
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled January 11, 2017

L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Firm received a complaint of the tip holder breaking during use.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
76494
Lot/product code:
Batch number: 15486
Recalling firm:
Kiscomedica S.A.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 18, 2017

Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.

Defective Container: Leakage of unit dose cups that may occur at the seal.

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

Recall #:
D-0469-2017
Lot/product code:
Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17
Recalling firm:
VistaPharm, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 2, 2017

PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493

The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.

ALARAZCACOCTFLIDILINKYLAMTNENJNMNYOKORSCTXWA
▸Full report

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

Recall #:
76875
Lot/product code:
Lot Numbers - 150323-04, 150324-04, 150520-10, 150615-01, 150616-08, 150709-01, 151229-64, 160414-69, 160510-59, 160617-52, 160824-50
Recalling firm:
CP Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 3, 2017

HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)

ALL 50 STATES
▸Full report

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

Recall #:
76600
Lot/product code:
HeartWare HVAD System Controller Product numbers: 1401US, 1401XX, 1403US, 1407XX, and 1400 with the serial Number(s) lower than CON300000 HeartWare HVAD DC Adapter Product number: 1435  .
Recalling firm:
Heartware
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 23, 2017

Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.

Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
76501
Lot/product code:
UDI Number 10844509000836 and 20844509000833.  Lot(s) Expiration Date 50910309 04-01-2017 60760309 03-16-2018 61460309 05-25-2018
Recalling firm:
Streck
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugForeign materialRecalled February 23, 2017

Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01.

Presence of Foreign Substance: foreign material found in the bulk inventory.

ALL 50 STATES
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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0513-2017
Lot/product code:
Lot numbers: 0113784, 0113786, 0113834, 0113887, Exp. 07/18
Recalling firm:
Mckesson Packaging Services
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled February 24, 2017

7-Eleven, Mantecada MUFFIN, Net Wt. 4 oz. , UPC 05254859241-7, in clear flexible plastic, Distributed by 7-Eleven, Inc., Irving, TX 750634.

Not listed on the label Allergen: Milk

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

Recall #:
F-1912-2017
Lot/product code:
UPC 05254859241-7, SKU #9841
Recalling firm:
Bak EZ
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 28, 2017

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.

ALL 50 STATES
▸Full report

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

Recall #:
76482
Lot/product code:
Serial Numbers: 1540070, 15450384, 15500476, 16020037, 16150086, 16260128, 16360182, 16450236, 15320037, 15450385, 15500477, 16020038, 16150087, 16260129, 16360183, 16450237, 15330049, 15450386, 15500478, 16020039, 16150088, 16260130, 16360184, 16450238, 15330052, 15450387, 15500479, 16020040, 16150089, 16260131, 16360185, 16450239, 15330053, 15450388, 15500480, 16040041, 16150090, 16260132, 16360186, 16450240, 15340074, 15450389, 15500481, 16040042, 16180091, 16260133, 16360187,  16460241, 15350086, 15450390, 15500482, 16040043, 16180091, 16260134, 16360188, 16460244, 15360096, 15450391, 15500483, 16040044, 16180092, 16260135, 16360189, 16460246, 15360105, 15450392, 15500484, 16040045, 16180092, 16260136, 16360190,  16460248, 15360108, 15450393, 15500485, 16040046, 16180093, 16260137, 16410191, 16460249, 15400254, 15460398, 15500486, 16040047, 16180094, 16260138, 16410192, 16460250, 15400255, 15480434, 15500487, 16040048, 16180095, 16260139, 16410193,  16500266, 15400256, 15480435, 15500488, 16040049, 16180096,  16260140, 16410194, 16500267, 15400257, 15480436, 15500489, 16040050, 16180097, 16260141, 16410195, 16500270, 15400258, 15480437, 15500490, 16040051, 16180098, 16260142, 16410196, 16500271, 15400259, 15480438, 15500491, 16040052, 16180099, 16260143, 16410197, 16500272, 15400260, 15480439, 15500492, 16040053, 16180100, 16260144, 16410198, 16500274, 15400261, 15480440, 15500493, 16040054, 16180101, 16260145, 16410199,  16500275, 15400262, 15480441, 16010001, 16040055, 16180102, 16260146, 16410200, 16500277, 15400263, 15480442, 16010002, 16040056, 16180103, 16260147, 16420201, 16500278, 15400264, 15480443, 16010003, 16040056, 16180104, 16260148, 16420202,  16500279, 15400265, 15480444, 16010004, 16040057, 16180105, 16260149, 16420203, 16500280, 15400266, 15480445, 16010005, 16040057, 16180106, 16260150, 16420204, 154000269, 15400267, 15480446, 16010006, 16040058, 16180107, 16260151, 16420205, 15400268, 15480447, 16010007, 16040058, 16180108, 16260152, 16420206, 15400270, 15480448, 16010008, 16040059, 16180109, 16260153, 16420207, 15400271, 15480449, 16010009, 16040059, 16180110, 16260154, 16420208, 15400272, 15480450, 16010010, 16040060, 16200111, 16260155, 16420209, 15400273, 15480451, 16010011, 16040060, 16200112, 16260156, 16420210, 15400274, 15480452, 16010012, 16040061, 16200113, 16260157, 16430211, 15400275, 15480453, 16010013, 16040062, 16200114, 16260158, 16430212, 15400276, 15480453, 16010014, 16040063, 16200115, 16260159, 16430213, 15400277, 15490454, 16010015, 16040064, 16200116, 16260160, 16430214, 15400278, 15490455, 16010016, 16040065, 16200117, 16260161, 16430215, 15400279, 15490456, 16010017, 16040066, 16200118, 16260162, 16430216, 15400280, 15490457, 16010018, 16040067, 16200119, 16260163, 16430217, 15400281, 15490458, 16010019, 16040068, 16200120, 16260164, 16430218, 15400282, 15490459, 16010020, 16040069, 16220121, 16260165, 16430219, 15400283, 15490460, 16020021, 16040070, 16220122, 16260166, 16430220, 15400284, 15490461, 16020022, 16040071, 16220123, 16260167, 16430221, 15400285, 15490462, 16020023, 16040072, 16220124, 16260168, 16430222, 15400286, 15490463, 16020024, 16040073, 16220125, 16260169, 16430223, 15400287, 15490464, 16020025, 16040074, 16220126, 16260170, 16430224, 15400288, 15490465, 16020026, 16040075, 16220127, 16360171, 16430225, 15410331, 15490466, 16020027, 16040076, 16220128, 16360172, 16430226, 15450374, 15490467, 16020028, 16040077, 16220129, 16360173, 16430227, 15450375, 15490468, 16020029, 16040078, 16220130, 16360174, 16430228, 15450376, 15490469, 16020030, 16040079, 16260121, 16360175, 16430229, 15450377, 15490470, 16020031, 16040080, 16260122, 16360176, 16430230, 15450378, 15490471, 16020032, 16150081, 16260123, 16360177, 16450231, 15450379, 15490472, 16020033, 16150082, 16260124, 16360178, 16450232, 15450380, 15490473, 16020034, 16150083, 16260125, 16360179, 16450233, 15450381, 15500474, 16020035, 16150084, 16260126, 16360180, 16450234, 15450383, 15500475, 16020036, 16150085, 16260127, 16360181, 16450235.
Recalling firm:
ConMed Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 28, 2017

HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796-19BX or P/N 7-796-19CS.

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were Sterile.

ALL 50 STATES
▸Full report

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

Recall #:
76482
Lot/product code:
Affected Lot Numbers: 201511234, 201512074, 201512094, 201601064, 201603284
Recalling firm:
ConMed Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 28, 2017

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.

ALL 50 STATES
▸Full report

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

Recall #:
76482
Lot/product code:
Serial Numbers: 1640179, 15500473, 16090084, 16140185, 16170283, 16250376, 16370476, 16380489, 1640180, 15510474, 16090085, 16140186, 16170284, 16250377, 16370477, 16380490, 1640181, 15510475, 16090086, 16140187, 16170285, 16250378, 16370478, 16380491, 1640182, 15510476, 16090087, 16140188, 16170286, 16260379, 16380479, 16380492, 1640183, 15510477, 16090088, 16140189, 16170287, 16260380, 16380480, 16480592, 1640184, 15510478, 16090089, 16140190, 16170288, 16260381, 16380481, 16480593, 1640185, 15510479, 16090090, 16140191, 16170289, 16260382, 16380482, 16480594, 1640186, 15510480, 16090091, 16140192, 16170290, 16260383, 16380483, 16480595, 1640187, 15510481, 16090092, 16140193, 16170291, 16260384, 16380484, 16480596, 1640188, 15510482, 16090093, 16140194, 16170292, 16260385, 16380485, 16480597, 15260015, 15510483, 16090094, 16140195, 16170293, 16260386, 16380486, 16480598, 15260016, 15510484, 16090095, 16140196, 16170294, 16260387, 16380487, 16480599, 15260018, 15510485, 16090096, 16140197, 16170295, 16260388, 16380488, 16500600, 15260020, 15510486, 16090097, 16140198, 16170296, 16260389, 16380493, 16500601, 15260022, 15510487, 16090098, 16150199, 16170297, 16260390, 16430494, 16500602, 15260023, 15510488, 16090099, 16150201, 16170298, 16260391, 16430495, 16500603, 15280038, 15510489, 16090100, 16150202, 16190299, 16260392, 16430496, 16500604, 15280044, 15510490, 16090101, 16150203, 16190300, 16260393, 16430497, 16500605, 15280046, 15510491, 16090102, 16150203, 16190301, 16260394, 16430499, 16500606, 15280048, 15510492, 16090103, 16150204, 16190302, 16260395, 16430500, 16500607, 15280049, 15510493, 16090104, 16150205, 16190303, 16260396, 16430501, 16500608, 15280052, 16010001, 16090105, 16150206, 16190304, 16260397, 16430502, 16500609, 15280053, 16010002, 16090106, 16150207, 16190305, 16260398, 16430503, 16500610, 15280054, 16010003, 16090107, 16150208, 16190306, 16260399, 16430504, 16500611, 15280055, 16010004, 16090108, 16150209, 16190307, 16260400, 16430505, 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16150222, 16210320, 16350413, 16440528, 16510624, 15340209, 16020018, 16090122, 16150223, 16210321, 16350414, 16440529, 16510626, 15340211, 16020019, 16090123, 16150224, 16210322, 16350415, 16440530, 16510627, 15340212, 16020020, 16110124, 16150225, 16210323, 16350416, 16440531, 16510628, 15340213, 16020021, 16110125, 16150226, 16210324, 16350417, 16440532, 16510630, 15340214, 16020022, 16110126, 16150227, 16210325, 16350418, 16440533, 16510631, 15340215, 16020023, 16110127, 16150228, 16210326, 16350419, 16440534, 16510632, 15340216, 16020024, 16110128, 16150229, 16210327, 16350420, 16440535, 16510633, 15340217, 16020025, 16110129, 16150230, 16210328, 16350421, 16440536, 16510634, 15340218, 16020026, 16110130, 16150231, 16210329, 16350422, 16440537, 16510635, 15340219, 16020027, 16110131, 16150232, 16210330, 16350423, 16440538, 16510638, 15340220, 16020028, 16110132, 16150233, 16210331, 16350424, 16460539, 16510639, 15340221, 16020029, 16110133, 16160234, 16210332, 16350425, 16460540, 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16… (truncated, 7709 characters total — see the official FDA record for the full value)
Recalling firm:
ConMed Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 28, 2017

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 The Hyfrecator 2000 Electrosurgical Unit is indicated for use in conjunction with an electrosurgical accessory handpiece for delivery of high frequency electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. The sterile sheaths are intended to cover the electrosurgical handpiece during those typical electrosurgical procedures and reduce the effort necessary to re-sterilize the handpiece between procedures.

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.

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

Recall #:
76482
Lot/product code:
Serial Numbers: 1618320 16020102 16070492 16110883 16171279 16231666 16382087 16402485 16442884 16493284 1618330 16020103 16070493 16110884 16171280 16231667 16382088 16412486 16442885 16493285 13181360 16020104 16070494 16110885 16171281 16231668 16382089 16412487 16442886 16493286 15010013 16020105 16070495 16120886 16171282 16231669 16382090 16412488 16442887 16493287 15070434 16020106 16070496 16120887 16171283 16231670 16382091 16412489 16442888 16493288 15221592 16020107 16070497 16120888 16171284 16231671 16382092 16412490 16442889 16493289 15221593 16020108 16070498 16120889 16171285 16231672 16382093 16412491 16442890 16493290 15221594 16020109 16070499 16120890 16171286 16231673 16382094 16412492 16442891 16493291 15221595 16020110 16070500 16120891 16171287 16231674 16382095 16412493 16442892 16493292 15221596 16020111 16080501 16120892 16171288 16231675 16382096 16412494 16442893 16493293 15221597 16020112 16080502 16120893 16171289 16231676 16382097 16412495 16442894 16493294 15221598 16020113 16080503 16120894 16171290 16231677 16382098 16412496 16442895 16493295 15221599 16020114 16080504 16120895 16171291 16231678 16382099 16412497 16442896 16493296 15221600 16020115 16080505 16120896 16171292 16231679 16382100 16412498 16442897 16493297 15240221 16020116 16080506 16120897 16171293 16231680 16382101 16412499 16442898 16493298 15250297 16020117 16080507 16120898 16171294 16231681 16382102 16412500 16442899 16493299 15300642 16020118 16080508 16120899 16171295 16231682 16382103 16412501 16442900 16493301 15300651 16020119 16080509 16120900 16171296 16231683 16382104 16412502 16442901 16493302 15320844 16020120 16080510 16120901 16171297 16231684 16382105 16412503 16442902 16493303 15320846 16020121 16080511 16120902 16171298 16231685 16382106 16412504 16442903 16493304 15320849 16020122 16080512 16120903 16171299 16231686 16382107 16412505 16442904 16493305 15330856 16020123 16080513 16120904 16171300 16231687 16382108 16412506 16442905 16493306 15330860 16020124 16080514 16120905 16171301 16231688 16382109 16412507 16442906 16493307 15330866 16020125 16080515 16120906 16171302 16231689 16382110 16412508 16442907 16493308 15330905 16020126 16080516 16120907 16171303 16231690 16382111 16412509 16442908 16493309 15330909 16020127 16080517 16120908 16171304 16231691 16382112 16412510 16442909 16493310 15340913 16020128 16080518 16120909 16171305 16231692 16382113 16412511 16442910 16493311 15340915 16020129 16080519 16120910 16171306 16231693 16382114 16412512 16442911 16493312 15340918 16020130 16080520 16120911 16171307 16231694 16382115 16412513 16442912 16493313 15340920 16020131 16080521 16120912 16171308 16231695 16382116 16412514 16442913 16493314 15340924 16020132 16080522 16120913 16171309  16231696 16382117 16412515 16442914 16493315 15340990 16020133 16080523 16120914 16171310 16231697 16382118 16412516 16442915 16493316 15340999 16020134 16080524 16120915 16171311 16231698 16382119 16412517 16442916 16493317 15351005 16020135 16080525 16120916 16171312  16231699 16382120 16412518 16442917 16493318 15351009 16020136 16080526 16120917 16171313 16231700 16382121 16412519 16442918 16493319 15351012 16020137 16080527 16120918 16171314 16231701 16382122 16412520 16442919 16493320 15351014 16020138 16080528 16120919 16171315 16231702 16382123 16412521 16442920 16493321 15351015 16020139 16080529 16120920 16181316 16231703 16382124 16412522 16452921 16493322 15351017 16020140 16080530 16120921 16181317 16231704 16382125 16412523 16452922 16493323 15351019 16030092 16080531 16120922 16181318 16231705 16382126 16412524 16452923 16493324 15351026 16040141 16080532 16120923 16181319 16231706 16382127 16412525 16452924 16493325 15351028 16040142 16080533 16120924 16181321 16231707 16382128 16412526 16452925 16493326 15351030 16040143 16080534 16120925 16181322 16231708 16382129 16412527 16452926 16493327 15401355 16040144 16080535 16120926 16181323 16231709 16382130 16412528 16452927 16493328 15401356 16040145 16080536 16120927 16181323 16231710 16382131 16412529 16452928 16493329 15401357 16040146 16080537 16120928 16181324 16241711 16382132 16412530 16452929 16493330 15401358 16040147 16080538 16120929 16181325 16241712 16382133 16412531 16452930 16503331 15401359 16040148 16080539 16120930 16181326 16241713 16382134 16412532 16452931 16503332 15401360 16040149 16080540 16120931 16181327 16241714 16382135 16412533 16452932 16503333 15401361 16040150 16080541 16120932 16181328 16241715 16382136 16412534 16452933 1… (truncated, 36190 characters total — see the official FDA record for the full value)
Recalling firm:
ConMed Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 28, 2017

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.

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

Recall #:
76482
Lot/product code:
Serial Numbers: 1540139, 15280024, 15420101, 15470153, 15510179, 16010007, 1540144, 15280026, 15420102, 15470161, 15510182, 16010008, 15250002, 15290032, 15430106, 15490169, 15510186, 16010009, 15250004, 15290033, 15430107, 15490170, 15510189, 16010010,  15250005, 15300038, 15430110, 15490172, 15510190, 16430108, 15250006, 15350041, 15430111, 15500173, 15510192, 16430109, 15250007, 15350043, 15430113, 15500174, 16010001, 16430112, 15250008, 15350044, 15430114, 15500175, 16010002, 15260010, 15360054, 15430115, 15500176, 16010003, 15260012, 15360057, 15460140, 15500177, 16010004, 15260013, 15360059, 15460142, 15510178, 16010005, 15280023, 15360060, 15460146, 15510179, 16010006.
Recalling firm:
ConMed Corporation
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Class IIModerate risk
DrugRecalled March 1, 2017

Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%, Octisalate 5.15%, Avobenzone 3.09%), Net Wt. 1.8 oz. (51 g) jar, Distributed by Signature Club A, Ltd, Tampa, FL 33609.

Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.

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

Recall #:
D-0662-2017
Lot/product code:
Lot #: 1626253/1746. Exp 10/18
Recalling firm:
Signature Club A Ltd
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UnclassifiedRisk not yet known
Medical deviceRecalled March 2, 2017

Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.

Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.

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

Recall #:
80771
Lot/product code:
00868579000209.
Recalling firm:
Ortho Kinematics, Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled March 2, 2017

Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels

Obstructed/blocked port from defective VGC Access Port Body component.

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

Recall #:
77508
Lot/product code:
Lot No. 4123/MY33613, 4250/MY06614, 4279/MY06614, 4305/MY10814, 4331/MY13914, and 4331/MY25214
Recalling firm:
Myelotec, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2017

SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.

Incorrectly labeled: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.

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

Recall #:
76775
Lot/product code:
Product Code: A300316A, Lot number: NGAV2400
Recalling firm:
C.R. Bard, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled March 10, 2017

HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).

In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.

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

Recall #:
76807
Lot/product code:
Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015
Recalling firm:
Heartware
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Class IHigh risk
DrugRecalled March 12, 2017

EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

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

Recall #:
D-0691-2017
Lot/product code:
US lot 5GN767, expiration April 2017; lot 5GN773, expiration April 2017; lot 6GN215, expiration Sep 2017: INTERNATIONAL lot 5GR765, expiration March 2017; lot 5GK771, expiration April 2017; lot 5ED824, expiration April 2017; and lot 6ED117, expiration ***
Recalling firm:
Meridian Medical Technologies a Pfizer Company
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled March 12, 2017

EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

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

Recall #:
D-0690-2017
Lot/product code:
US: lot 5GM631, exp. April 2017; lot 5GM640, exp. May 2017; lot 6GM072, exp. Sep 2017; lot 6GM082, exp. Sep 2017; lot 6GM088, exp. Oct 2017; lot 6GM087, exp. Oct 2017; lot 6GM198, exp. Oct 2017; lot 6GM081, exp. Sep 2017; lot 6GM091, exp. Oct 2017; lot 6GM199, exp. Oct 2017: INTERNATIONAL: lot 5FA665, exp. April 2017; lot 5GU763, exp. May 2017; lot 6FA293, exp. Oct 2017; lot 6FA292, exp. Oct 2017; lot 6GH294, exp. Oct 2017.
Recalling firm:
Meridian Medical Technologies a Pfizer Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 13, 2017

Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are designed to be used with any patient monitoring system designed to accept 400 Series temperature probes.

The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.

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

Recall #:
78036
Lot/product code:
Part No. 401AC (Lot No. 14K87246, 15M96863, 13E72645, 12D61386, 13D72302, 16B97593, 15C91286, 13B64377, 14J86547, 12B59416, 13A69334, 15K95972, 15A97196, 15E92377, 15F92378, 13L77336, 12D61023, 14G84704, 14K87499, 14F84193, 13L77335, 16B97594, 15C91419, 13B70167, 15C91448, 15E92375, 15K96046, 16A97197, 12B59529, 16B97798, 15K96125, 16B97595, 15L96777, 12D61829, 13D72644, 15A89998, 13F73449, 12M64134, 15L96745, 15D90215, 15H95035, 13F74403, 13L78489, 13L77336, 12H65961, 14G84878, 12F62179, 14J87014, 12B55182, 14F84444, 14J87081, 13L77336, 13L78489, 14F84400, 12J66632, 16A97380, 12M68130, 15E92376, 14L88737, 14L87904, 12K66633, 13H74994, 13H74995, 12B60056, 12C57285, 14H86266, 16A97592, 14J87164, 12D59168, 14M89765, 12A54328, 15A89854, 14F84634, 14G84624, 15M96829, 15K95896);    Part No. 402AC (Lot No. 13E73262, 15E92379, 12E57286, 12L68344, 15E93385, 12H65752, 12H65787, 15F92380, 12J65322, 15F92381, 12K67454, 15A89941, 15A89282, 13H75930, 12F55548, 12K67533, 13H75930, 12J66809, 12B59570, 15E92010, 12A50150, 14E83393);    Part No. 409AC (Lot No. 12C56215, 12B56215, 15C90920, 15K28358, 12C60069, 13B70035, 16B97312, 13A69520, 14E83602, 13E73264, 12L68584, 11M57610, 12F59571, 15B90832, 15E92560, 12K63370, 16B97614, 12L54648, 15D92011, 12M63372, 14H85773, 16B97615, 15M97109, 16B97805, 12M69229, 15A89939, 15A90196, 12F60692, 14L88520, 14L88519, 13A70145, 15E92382, 15A90466, 13E73450, 15F92383, 13D72925)
Recalling firm:
Measurement Specialties Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled March 14, 2017

Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

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

Recall #:
77198
Lot/product code:
Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166. NBS158 has been scrapped.
Recalling firm:
Nexstim PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 14, 2017

NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

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

Recall #:
77198
Lot/product code:
Serial numbers: NBS10391245N4, NBS11011250N4, NBS11071252N4, NBS11201252N4, NBS11451264N4, NBS11491268N4, NBS12051269N4, NBS12261274N4, NBS12341276N4, NBS12441278N4, NBS13341282N4, NBS13431283N4, NBS13451284N4, NBS13481286N4, NBS14011288N4, NBS14361295N5, NBS14481298N5, NBS14491299N5, NBS14511301N5, NBS15131302N5, Serial numbers: NBS10391245N4, NBS11011250N4, NBS11071252N4, NBS11451264N4, NBS11491268N4, NBS12051269N4, NBS12261274N4, NBS12341276N4, NBS12441278N4, NBS13341282N4, NBS13431283N4, NBS13451284N4, NBS14011288N4, NBS14481298N5, NBS14491299N5, NBS14511301N5, NBS15131302N5, NBS15271305N5, NBS15371307N5, NBS16031313N5 and NBS16221316N5. Additionally in Nexstim's warehouse (i.e. not distributed NBS 11201256N4, NBS 13481286N4, NBS 14361295N5 and NBS 16371318N5)
Recalling firm:
Nexstim PLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 22, 2017

Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.

Defective Delivery System: Elevated number of units with not meeting quality requirements results for leak rate.

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

Recall #:
D-0626-2017
Lot/product code:
Lot #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
Recalling firm:
GlaxoSmithKline, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2017

WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures

Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.

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

Recall #:
77102
Lot/product code:
73H1600207
Recalling firm:
Teleflex Medical
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UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2017

Craftmatic Model 1 Base for Dual Bed Configurations

A potential for dual-configured beds to separate or slip away from one another.

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

Recall #:
89765
Lot/product code:
4AM663, 4AM669, 4AR391, 4AR445, 4AR797, 4AR790, 4AR795
Recalling firm:
Craftmatic Industries, Inc.
View official FDA record (opens in a new tab)