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Recalls affecting Iowa

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

16,604 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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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/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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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.

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UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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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

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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.

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UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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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

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UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2020

Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

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

Recall #:
86607
Lot/product code:
Lots  060620MB1  061420MB2  062120MB1  062220MB2  060620MB2  052220MB1  051820D01  060120D01  061520MA1  062220D02  061720MB1  052720D02  061920E01  052120E01
Recalling firm:
Thomas Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

The product contains a non-functional component not referenced in product labeling.

ALL 50 STATES
▸Full report

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

Recall #:
86115
Lot/product code:
1. STQ4 RCV A0 US: Serial numbers: 211766-1, 211766-10, 211766-11, 211766-12, 211766-13, 211766-14, 211766-15, 211766-16, 211766-17, 211766-18, 211766-19, 211766-2, 211766-20, 211766-21, 211766-22, 211766-23, 211766-24, 211766-25, 211766-26, 211766-27, 211766-28, 211766-29, 211766-3, 211766-30, 211766-31, 211766-32, 211766-33, 211766-34, 211766-35, 211766-36, 211766-37, 211766-38, 211766-39, 211766-4, 211766-40, 211766-41, 211766-42, 211766-43, 211766-44, 211766-45, 211766-46, 211766-47, 211766-48, 211766-49, 211766-5, 211766-50, 211766-51, 211766-52, 211766-53, 211766-54, 211766-55, 211766-56, 211766-57, 211766-58, 211766-59, 211766-6, 211766-60, 211766-61, 211766-62, 211766-63, 211766-64, 211766-65, 211766-66, 211766-67, 211766-68, 211766-69, 211766-7, 211766-70, 211766-71, 211766-72, 211766-73, 211766-74, 211766-75, 211766-76, 211766-77, 211766-78, 211766-79, 211766-8, 211766-80, 211766-81, 211766-82, 211766-83, 211766-84, 211766-85, 211766-86, 211766-87, 211766-88, 211766-89, 211766-9, 211766-90, 211766-91, 211766-92, 211766-93, 211766-94, 211766-95, 211670-1, 211670-1, 211670-10, 211670-11, 211670-12, 211670-13, 211670-14, 211670-15, 211670-16, 211670-17, 211670-18, 211670-19, 211670-2, 211670-20, 211670-21, 211670-22, 211670-23, 211670-24, 211670-25, 211670-26, 211670-27, 211670-28, 211670-29, 211670-3, 211670-30, 211670-31, 211670-32, 211670-33, 211670-34, 211670-35, 211670-36, 211670-37, 211670-38, 211670-39, 211670-4, 211670-40, 211670-41, 211670-42, 211670-43, 211670-44, 211670-45, 211670-46, 211670-47, 211670-48, 211670-49, 211670-5, 211670-50, 211670-6, 211670-7, 211670-8, 211670-9, 211669-1, 211669-1, 211669-10, 211669-11, 211669-12, 211669-13, 211669-14, 211669-15, 211669-16, 211669-17, 211669-18, 211669-19, 211669-2, 211669-20, 211669-21, 211669-22, 211669-23, 211669-24, 211669-25, 211669-26, 211669-27, 211669-28, 211669-29, 211669-3, 211669-30, 211669-31, 211669-32, 211669-33, 211669-34, 211669-35, 211669-36, 211669-37, 211669-38, 211669-39, 211669-4, 211669-40, 211669-41, 211669-42, 211669-43, 211669-44, 211669-45, 211669-46, 211669-47, 211669-48, 211669-49, 211669-5, 211669-50, 211669-51, 211669-52, 211669-53, 211669-54, 211669-55, 211669-56, 211669-57, 211669-58, 211669-59, 211669-6, 211669-60, 211669-61, 211669-62, 211669-63, 211669-64, 211669-65, 211669-66, 211669-67, 211669-68, 211669-69, 211669-7, 211669-70, 211669-71, 211669-72, 211669-73, 211669-74, 211669-75, 211669-76, 211669-77, 211669-78, 211669-79, 211669-8, 211669-80, 211669-81, 211669-82, 211669-83, 211669-84, 211669-85, 211669-86, 211669-87, 211669-88, 211669-89, 211669-9, 211669-90, 211669-91, 211669-92, 211669-93, 211669-94, 211669-95, 211669-96, 211669-97, 211669-98, 211669-99, 211569-1, 211569-1, 211569-10, 211569-11, 211569-12, 211569-13, 211569-14, 211569-15, 211569-16, 211569-17, 211569-18, 211569-19, 211569-2, 211569-20, 211569-21, 211569-22, 211569-23, 211569-27, 211569-28, 211569-29, 211569-3, 211569-30, 211569-31, 211569-32, 211569-33, 211569-34, 211569-35, 211569-36, 211569-37, 211569-38, 211569-39, 211569-4, 211569-40, 211569-41, 211569-42, 211569-43, 211569-44, 211569-45, 211569-47, 211569-49, 211569-5, 211569-50, 211569-51, 211569-52, 211569-53, 211569-54, 211569-55, 211569-56, 211569-57, 211569-58, 211569-59, 211569-60, 211569-61, 211569-65, 211569-66, 211569-7, 211569-70, 211569-71, 211569-72, 211569-73, 211569-74, 211569-75, 211569-76, 211569-77, 211569-78, 211569-79, 211569-8, 211569-80, 211569-81, 211569-82, 211569-83, 211569-84, 211569-85, 211569-86, 211569-87, 211569-9, 211188-1, 211188-1, 211188-10, 211188-11, 211188-12, 211188-13, 211188-14, 211188-15, 211188-16, 211188-17, 211188-18, 211188-19, 211188-2, 211188-20, 211188-21, 211188-22, 211188-23, 211188-24, 211188-25, 211188-26, 211188-27, 211188-28, 211188-29, 211188-3, 211188-30, 211188-31, 211188-32, 211188-33, 211188-34, 211188-35, 211188-36, 211188-37, 211188-38, 211188-39, 211188-4, 211188-40, 211188-41, 211188-42, 211188-43, 211188-44, 211188-45, 211188-46, 211188-47, 211188-48, 211188-49, 211188-5, 211188-50, 211188-51, 211188-52, 211188-53, 211188-54, 211188-55, 211188-56, 211188-57, 211188-58, 211188-59, 211188-6, 211188-60, 211188-61, 211188-62, 211188-63, 211188-64, 211188-65, 211188-66, 211188-67, 211188-68, 211188-69, 211188-7, 211188-70, 211188-71, 211188-72, 211188-73, 211188-74, 211188-75, 211188-76, 211188-8, 211188-9, 211087-100, 211087-101, 211087-102, 211087-103, 211087-104, 211087-105, 211087-106, 211087-107, 211087-81, 211087-82, 211087-83, 211087-84, 211087-85, 211087-86, 211087-87, 211087-88, 211087-89, 211087-90, 211087-91, 211087-92, 211087-93, 211087-94, 211087-95, 211087-96, 211087-97, 211087-98, 211087-99, 211054-1, 211054-10, 211054-100, 211054-101, 211054-102, 211054-103, 211054-104, 211054-105, 211054-106, 211054-107, 211054-108, 211054-109, 211054-11, 211054-110, 211054-111, 211054-112, 211054-113, 211054-114, 211054-115, 211054-116, 211054-117, 211054-118, 211054-119, 211054-12, 211054-120, 211054-13, 211054-14, 2… (truncated, 30266 characters total — see the official FDA record for the full value)
Recalling firm:
Stimwave Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

The product contains a non-functional component not referenced in product labeling.

ALL 50 STATES
▸Full report

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

Recall #:
86115
Lot/product code:
1. FR4A-RCV-A0 US, Serial Numbers: 210426-88, 210426-89, 210426-90, 210426-91, 210426-92, 210426-93; 2. FR4A-RCV-A0 EU, Serial Numbers: 210425-19, 210425-22, 210425-23, 210425-6, 210425-63, 210425-64, 210425-7.
Recalling firm:
Stimwave Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

The product contains a non-functional component not referenced in product labeling.

ALL 50 STATES
▸Full report

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

Recall #:
86115
Lot/product code:
FR4A-SPR-BO-US, Serial Numbers: 210431-88, 210431-89, 210431-90, 210431-91, 210431-92, 210431-93;
Recalling firm:
Stimwave Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

The product contains a non-functional component not referenced in product labeling.

ALL 50 STATES
▸Full report

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

Recall #:
86115
Lot/product code:
Serial Numbers: 211662-1, 211662-10, 211662-11, 211662-12, 211662-13, 211662-14, 211662-15, 211662-16, 211662-17, 211662-18, 211662-19, 211662-2, 211662-20, 211662-21, 211662-22, 211662-23, 211662-24, 211662-25, 211662-26, 211662-27, 211662-28, 211662-29, 211662-3, 211662-30, 211662-31, 211662-32, 211662-33, 211662-34, 211662-35, 211662-36, 211662-37, 211662-38, 211662-39, 211662-4, 211662-40, 211662-41, 211662-42, 211662-43, 211662-44, 211662-45, 211662-46, 211662-47, 211662-48, 211662-49, 211662-5, 211662-50, 211662-51, 211662-52, 211662-53, 211662-54, 211662-55, 211662-56, 211662-57, 211662-58, 211662-59, 211662-6, 211662-60, 211662-61, 211662-62, 211662-63, 211662-64, 211662-65, 211662-66, 211662-67, 211662-68, 211662-69, 211662-7, 211662-70, 211662-71, 211662-72, 211662-73, 211662-74, 211662-75, 211662-76, 211662-77, 211662-78, 211662-79, 211662-8, 211662-80, 211662-81, 211662-82, 211662-83, 211662-84, 211662-85, 211662-86, 211662-87, 211662-88, 211662-89, 211662-9, 211662-90, 211662-91 211613-1, 211613-10, 211613-100, 211613-101, 211613-102, 211613-103, 211613-104, 211613-105, 211613-106, 211613-107, 211613-108, 211613-109, 211613-11, 211613-110, 211613-12, 211613-13, 211613-14, 211613-15, 211613-16, 211613-17, 211613-18, 211613-19, 211613-2, 211613-20, 211613-21, 211613-22, 211613-23, 211613-24, 211613-25, 211613-26, 211613-27, 211613-28, 211613-29, 211613-3, 211613-30, 211613-31, 211613-32, 211613-33, 211613-34, 211613-35, 211613-36, 211613-37, 211613-38, 211613-39, 211613-4, 211613-40, 211613-41, 211613-42, 211613-43, 211613-44, 211613-45, 211613-46, 211613-47, 211613-48, 211613-49, 211613-5, 211613-50, 211613-51, 211613-52, 211613-53, 211613-54, 211613-55, 211613-56, 211613-57, 211613-58, 211613-59, 211613-6, 211613-60, 211613-61, 211613-62, 211613-63, 211613-64, 211613-65, 211613-66, 211613-67, 211613-68, 211613-69, 211613-7, 211613-70, 211613-71, 211613-72, 211613-73, 211613-74, 211613-75, 211613-76, 211613-77, 211613-78, 211613-79, 211613-8, 211613-80, 211613-81, 211613-82, 211613-83, 211613-84, 211613-85, 211613-86, 211613-87, 211613-88, 211613-89, 211613-9, 211613-90, 211613-91, 211613-92, 211613-93, 211613-94, 211613-95, 211613-96, 211613-97, 211613-98, 211613-99 211577-1, 211577-10, 211577-11, 211577-12, 211577-13, 211577-14, 211577-15, 211577-16, 211577-17, 211577-18, 211577-19, 211577-2, 211577-20, 211577-21, 211577-22, 211577-23, 211577-24, 211577-25, 211577-26, 211577-27, 211577-28, 211577-29, 211577-3, 211577-30, 211577-31, 211577-32, 211577-33, 211577-34, 211577-35, 211577-36, 211577-37, 211577-38, 211577-39, 211577-4, 211577-40, 211577-41, 211577-42, 211577-43, 211577-44, 211577-45, 211577-46, 211577-47, 211577-48, 211577-49, 211577-5, 211577-50, 211577-51, 211577-52, 211577-53, 211577-54, 211577-55, 211577-56, 211577-57, 211577-58, 211577-59, 211577-6, 211577-60, 211577-61, 211577-62, 211577-63, 211577-64, 211577-65, 211577-66, 211577-67, 211577-68, 211577-69, 211577-7, 211577-70, 211577-71, 211577-72, 211577-73, 211577-74, 211577-75, 211577-76, 211577-77, 211577-78, 211577-79, 211577-8, 211577-80, 211577-81, 211577-82, 211577-83, 211577-84, 211577-85, 211577-86, 211577-87, 211577-88, 211577-89, 211577-9, 211577-90, 211577-91, 211577-92, 211577-93, 211577-94, 211577-95, 211577-96, 211577-97, 211577-98, 211577-99 211576-1, 211576-10, 211576-11, 211576-12, 211576-13, 211576-14, 211576-15, 211576-16, 211576-17, 211576-18, 211576-19, 211576-2, 211576-20, 211576-23, 211576-24, 211576-25, 211576-26, 211576-27, 211576-28, 211576-29, 211576-30, 211576-31, 211576-33, 211576-34, 211576-35, 211576-36, 211576-37, 211576-38, 211576-39, 211576-41, 211576-42, 211576-43, 211576-44, 211576-45, 211576-46, 211576-47, 211576-48, 211576-49, 211576-5, 211576-51, 211576-52, 211576-53, 211576-54, 211576-55, 211576-58, 211576-59, 211576-6, 211576-60, 211576-61, 211576-63, 211576-64, 211576-66, 211576-67, 211576-68, 211576-69, 211576-7, 211576-70, 211576-71, 211576-76, 211576-78, 211576-79, 211576-8, 211576-80, 211576-81, 211576-82, 211576-83, 211576-84, 211576-85, 211576-86, 211576-87, 211576-89, 211576-9, 211576-90, 211576-91, 211576-92, 211576-94 2B10865-1, 2B10865-2, 2B10865-3, 2B10865-4, 2B10865-5, 2B10865-6, 2B10865-7, 2B10865-8, 2B10865-9, 2B10865-10, 2B10865-11, 2B10865-12, 2B10865-13, 2B10865-14, 2B10865-15, 2B10865-16, 2B10865-17, 2B10865-18, 2B10865-19, 2B10865-20, 2B10865-21, 2B10865-22, 2B10865-23, 2B10865-24, 2B10865-25, 2B10865-26, 2B10865-27, 2B10865-28, 2B10865-29, 2B10865-30, 2B10865-31, 2B10865-32, 2B10865-33, 2B10865-34, 2B10865-35, 2B10865-36, 2B10865-37, 2B10865-38, 2B10865-39, 2B10865-40, 2B10865-41, 2B10865-42, 2B10865-43, 2B10865-44, 2B10865-45, 2B10865-46, 2B10865-47, 2B10865-48, 2B10865-49, 2B10865-50, 2B10865-51, 2B10865-52, 2B10865-53, 2B10865-54, 2B10865-55, 2B10865-56, 2B10865-57, 2B10865-58, 2B10865-59, 2B10865-60, 2B10865-61, 2B10865-62, 2B10865-63, 2B10865-64, 2B10865-65, 2B10865-66, 2B10865-67, 2B10865-68, 2B10865-69, 2B10865-70, 2B10865-71, 2B10865-72, 2B10865-73… (truncated, 21140 characters total — see the official FDA record for the full value)
Recalling firm:
Stimwave Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

The product contains a non-functional component not referenced in product labeling.

ALL 50 STATES
▸Full report

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

Recall #:
86115
Lot/product code:
1. STQ4-SPR-B0 US, Serial Numbers: 211668-1, 211668-10, 211668-11, 211668-12, 211668-13, 211668-14, 211668-15, 211668-16, 211668-17, 211668-18, 211668-19, 211668-2, 211668-20, 211668-21, 211668-22, 211668-23, 211668-24, 211668-25, 211668-26, 211668-27, 211668-28, 211668-29, 211668-3, 211668-30, 211668-31, 211668-32, 211668-33, 211668-34, 211668-35, 211668-36, 211668-37, 211668-38, 211668-39, 211668-4, 211668-40, 211668-41, 211668-42, 211668-43, 211668-44, 211668-45, 211668-46, 211668-47, 211668-48, 211668-49, 211668-5, 211668-50, 211668-51, 211668-52, 211668-53, 211668-54, 211668-55, 211668-56, 211668-57, 211668-58, 211668-59, 211668-6, 211668-60, 211668-61, 211668-62, 211668-63, 211668-64, 211668-65, 211668-66, 211668-67, 211668-68, 211668-69, 211668-7, 211668-70, 211668-71, 211668-72, 211668-73, 211668-74, 211668-75, 211668-76, 211668-77, 211668-78, 211668-79, 211668-8, 211668-80, 211668-81, 211668-82, 211668-83, 211668-84, 211668-85, 211668-86, 211668-87, 211668-88, 211668-89, 211668-9, 211668-90, 211668-91, 211668-92, 211570-1, 211570-10, 211570-11, 211570-12, 211570-13, 211570-14, 211570-15, 211570-16, 211570-17, 211570-18, 211570-19, 211570-2, 211570-20, 211570-21, 211570-22, 211570-23, 211570-24, 211570-25, 211570-26, 211570-27, 211570-28, 211570-29, 211570-3, 211570-30, 211570-31, 211570-32, 211570-33, 211570-34, 211570-35, 211570-36, 211570-37, 211570-38, 211570-39, 211570-4, 211570-40, 211570-41, 211570-42, 211570-43, 211570-44, 211570-45, 211570-46, 211570-47, 211570-48, 211570-49, 211570-5, 211570-50, 211570-51, 211570-52, 211570-53, 211570-54, 211570-55, 211570-56, 211570-57, 211570-58, 211570-59, 211570-6, 211570-60, 211570-61, 211570-62, 211570-63, 211570-64, 211570-65, 211570-66, 211570-67, 211570-68, 211570-69, 211570-7, 211570-70, 211570-71, 211570-72, 211570-73, 211570-74, 211570-75, 211570-76, 211570-77, 211570-78, 211570-79, 211570-8, 211570-80, 211570-81, 211570-82, 211570-83, 211570-84, 211570-85, 211570-86, 211570-87, 211570-88, 211570-89, 211570-9, 211569-69, 211187-1, 211187-10, 211187-11, 211187-12, 211187-13, 211187-14, 211187-15, 211187-16, 211187-17, 211187-18, 211187-19, 211187-2, 211187-20, 211187-21, 211187-22, 211187-23, 211187-24, 211187-25, 211187-26, 211187-27, 211187-28, 211187-29, 211187-3, 211187-30, 211187-31, 211187-32, 211187-33, 211187-34, 211187-35, 211187-36, 211187-37, 211187-38, 211187-39, 211187-4, 211187-40, 211187-41, 211187-42, 211187-43, 211187-44, 211187-45, 211187-46, 211187-47, 211187-48, 211187-49, 211187-5, 211187-50, 211187-51, 211187-52, 211187-53, 211187-54, 211187-55, 211187-56, 211187-57, 211187-58, 211187-59, 211187-6, 211187-60, 211187-61, 211187-62, 211187-63, 211187-64, 211187-65, 211187-66, 211187-67, 211187-68, 211187-69, 211187-7, 211187-70, 211187-71, 211187-72, 211187-73, 211187-8, 211187-9, 211128-10, 211128-11, 211128-3, 211128-4, 211128-5, 211128-6, 211128-7, 211128-8, 211128-9, 210966-1, 210966-10, 210966-11, 210966-12, 210966-13, 210966-14, 210966-15, 210966-16, 210966-17, 210966-18, 210966-19, 210966-2, 210966-20, 210966-21, 210966-22, 210966-23, 210966-24, 210966-25, 210966-26, 210966-27, 210966-28, 210966-29, 210966-3, 210966-30, 210966-31, 210966-32, 210966-33, 210966-34, 210966-35, 210966-36, 210966-37, 210966-38, 210966-39, 210966-4, 210966-40, 210966-41, 210966-42, 210966-43, 210966-44, 210966-5, 210966-6, 210966-7, 210966-8, 210966-9, 210960-1, 210960-10, 210960-11, 210960-12, 210960-13, 210960-14, 210960-15, 210960-16, 210960-17, 210960-18, 210960-19, 210960-2, 210960-20, 210960-21, 210960-22, 210960-23, 210960-24, 210960-25, 210960-26, 210960-27, 210960-28, 210960-29, 210960-3, 210960-30, 210960-31, 210960-32, 210960-33, 210960-34, 210960-35, 210960-36, 210960-37, 210960-38, 210960-39, 210960-4, 210960-40, 210960-41, 210960-42, 210960-43, 210960-44, 210960-45, 210960-46, 210960-47, 210960-48, 210960-49, 210960-5, 210960-50, 210960-51, 210960-52, 210960-53, 210960-54, 210960-55, 210960-56, 210960-57, 210960-58, 210960-59, 210960-6, 210960-60, 210960-61, 210960-62, 210960-63, 210960-64, 210960-65, 210960-66, 210960-67, 210960-68, 210960-69, 210960-7, 210960-8, 210960-9, 210049-1, 210049-10, 210049-11, 210049-12, 210049-13, 210049-14, 210049-15, 210049-16, 210049-17, 210049-18, 210049-19, 210049-2, 210049-20, 210049-21, 210049-3, 210049-4, 210049-5, 210049-6, 210049-7, 210049-8, 210049-9, 210028-1, 210028-10, 210028-11, 210028-12, 210028-13, 210028-14, 210028-15, 210028-16, 210028-17, 210028-18, 210028-19, 210028-2, 210028-20, 210028-21, 210028-22, 210028-23, 210028-24, 210028-25, 210028-26, 210028-27, 210028-28, 210028-29, 210028-3, 210028-30, 210028-31, 210028-32, 210028-33, 210028-34, 210028-35, 210028-36, 210028-37, 210028-38, 210028-39, 210028-4, 210028-40, 210028-41, 210028-42, 210028-43, 210028-44, 210028-45, 210028-46, 210028-47, 210028-48, 210028-49, 210028-5, 210028-50, 210028-51, 210028-52, 210028-53, 210028-54, 210028-55, 210028-56, 210028-57, 210028-58, 210028-59, 210028-6, 210028-60, 210028-61, 210028-62, 2100… (truncated, 24793 characters total — see the official FDA record for the full value)
Recalling firm:
Stimwave Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

The product contains a non-functional component not referenced in product labeling.

ALL 50 STATES
▸Full report

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

Recall #:
86115
Lot/product code:
1. FR4A-TRL-BO-US, Serial Numbers: 211666-1, 211666-10, 211666-11, 211666-12, 211666-13, 211666-14, 211666-15, 211666-16, 211666-17, 211666-18, 211666-19, 211666-2, 211666-20, 211666-21, 211666-22, 211666-23, 211666-24, 211666-25, 211666-26, 211666-27, 211666-28, 211666-29, 211666-3, 211666-30, 211666-31, 211666-32, 211666-33, 211666-34, 211666-35, 211666-36, 211666-37, 211666-38, 211666-39, 211666-4, 211666-40, 211666-41, 211666-42, 211666-43, 211666-44, 211666-45, 211666-46, 211666-47, 211666-48, 211666-49, 211666-5, 211666-50, 211666-51, 211666-52, 211666-53, 211666-54, 211666-55, 211666-56, 211666-57, 211666-58, 211666-59, 211666-6, 211666-60, 211666-61, 211666-62, 211666-63, 211666-64, 211666-65, 211666-66, 211666-67, 211666-68, 211666-69, 211666-7, 211666-70, 211666-71, 211666-72, 211666-73, 211666-74, 211666-75, 211666-76, 211666-77, 211666-78, 211666-79, 211666-8, 211666-80, 211666-81, 211666-82, 211666-83, 211666-84, 211666-85, 211666-86, 211666-87, 211666-88, 211666-89, 211666-9, 211666-90, 211666-91, 211666-92, 211666-93, 211666-94, 211666-95, 211666-96, 211666-97, 211666-98 211614-1, 211614-10, 211614-11, 211614-12, 211614-13, 211614-14, 211614-15, 211614-16, 211614-17, 211614-18, 211614-19, 211614-2, 211614-20, 211614-21, 211614-22, 211614-23, 211614-24, 211614-25, 211614-26, 211614-27, 211614-28, 211614-29, 211614-3, 211614-30, 211614-31, 211614-32, 211614-33, 211614-34, 211614-35, 211614-36, 211614-37, 211614-38, 211614-39, 211614-4, 211614-40, 211614-41, 211614-42, 211614-43, 211614-44, 211614-45, 211614-46, 211614-47, 211614-48, 211614-49, 211614-5, 211614-50, 211614-51, 211614-52, 211614-53, 211614-54, 211614-55, 211614-56, 211614-57, 211614-58, 211614-59, 211614-6, 211614-60, 211614-61, 211614-62, 211614-63, 211614-64, 211614-65, 211614-66, 211614-67, 211614-68, 211614-69, 211614-7, 211614-70, 211614-71, 211614-72, 211614-73, 211614-74, 211614-75, 211614-76, 211614-77, 211614-78, 211614-79, 211614-8, 211614-80, 211614-81, 211614-82, 211614-83, 211614-84, 211614-85, 211614-86, 211614-87, 211614-88, 211614-89, 211614-9, 211614-90, 211614-91, 211614-92, 211614-93, 211614-94, 211614-95 , 211579-1, 211579-10, 211579-11, 211579-12, 211579-13, 211579-14, 211579-15, 211579-16, 211579-17, 211579-18, 211579-19, 211579-2, 211579-20, 211579-21, 211579-22, 211579-23, 211579-24, 211579-25, 211579-26, 211579-30, 211579-31, 211579-32, 211579-33, 211579-34, 211579-35, 211579-36, 211579-37, 211579-38, 211579-4, 211579-40, 211579-41, 211579-42, 211579-43, 211579-45, 211579-46, 211579-49, 211579-5, 211579-50, 211579-51, 211579-52, 211579-53, 211579-54, 211579-55, 211579-56, 211579-57, 211579-58, 211579-59, 211579-6, 211579-61, 211579-62, 211579-63, 211579-64, 211579-65, 211579-66, 211579-67, 211579-68, 211579-69, 211579-7, 211579-70, 211579-71, 211579-72, 211579-73, 211579-74, 211579-75, 211579-76, 211579-77, 211579-78, 211579-79, 211579-8, 211579-80, 211579-81, 211579-82, 211579-83, 211579-84, 211579-85, 211579-86, 211579-87, 211579-88, 211579-89, 211579-9, 211579-90, 211579-91, 211579-95, 211579-97, 211579-98 211578-1, 211578-10, 211578-11, 211578-12, 211578-13, 211578-14, 211578-15, 211578-16, 211578-17, 211578-18, 211578-19, 211578-2, 211578-20, 211578-21, 211578-22, 211578-23, 211578-24, 211578-25, 211578-26, 211578-27, 211578-28, 211578-29, 211578-3, 211578-30, 211578-31, 211578-32, 211578-33, 211578-34, 211578-35, 211578-36, 211578-37, 211578-38, 211578-39, 211578-4, 211578-40, 211578-41, 211578-42, 211578-43, 211578-44, 211578-45, 211578-46, 211578-47, 211578-48, 211578-49, 211578-5, 211578-50, 211578-51, 211578-52, 211578-53, 211578-54, 211578-55, 211578-56, 211578-57, 211578-58, 211578-59, 211578-6, 211578-60, 211578-61, 211578-62, 211578-63, 211578-64, 211578-65, 211578-66, 211578-67, 211578-68, 211578-69, 211578-7, 211578-70, 211578-71, 211578-72, 211578-73, 211578-74, 211578-75, 211578-76, 211578-77, 211578-78, 211578-79, 211578-8, 211578-80, 211578-81, 211578-82, 211578-83, 211578-84, 211578-85, 211578-86, 211578-87, 211578-88, 211578-89, 211578-9, 211578-90, 211578-91, 211578-92 2B10866-1, 2B10866-2, 2B10866-3, 2B10866-4, 2B10866-5, 2B10866-6, 2B10866-7, 2B10866-8, 2B10866-9, 2B10866-10, 2B10866-11, 2B10866-12, 2B10866-13, 2B10866-14, 2B10866-15, 2B10866-16, 2B10866-17, 2B10866-18, 2B10866-19, 2B10866-20, 2B10866-21, 2B10866-22, 2B10866-23, 2B10866-24, 2B10866-25, 2B10866-26, 2B10866-27, 2B10866-28, 2B10866-29, 2B10866-30, 2B10866-31, 2B10866-32, 2B10866-33, 2B10866-34, 2B10866-35, 2B10866-36, 2B10866-37, 2B10866-38, 2B10866-39, 2B10866-40, 2B10866-41, 2B10866-42, 2B10866-43, 2B10866-44, 2B10866-45, 2B10866-46, 2B10866-47, 2B10866-48, 2B10866-49, 2B10866-50, 2B10866-51, 2B10866-52, 2B10866-53, 2B10866-54, 2B10866-55, 2B10866-56, 2B10866-57, 2B10866-58, 2B10866-59, 2B10866-60, 2B10866-61, 2B10866-62, 2B10866-63, 2B10866-64, 2B10866-65, 2B10866-66, 2B10866-67, 2B10866-68, 2B10866-69, 2B10866-70, 2B10866-71, 2B10866-72, 2B10866-73, 2B10866-74, 2B10866-75, 2B10866-76, 2B10866-77, 2B10866-7… (truncated, 16111 characters total — see the official FDA record for the full value)
Recalling firm:
Stimwave Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2020

Tibial knee prosthesis

Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

ALARAZCTFLGAIAINKYLAMAMIMNMONCNJNVNYOHPASCTNTXWIWV
▸Full report

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

Recall #:
86068
Lot/product code:
Model: 71420164; 71420166 and 71420184  Lot Numbers: 19MT31457, 19MT31458,19MT31459, 20AT32611, 20AT32612, 20AT32613, 20AT33540, 20AT33541, 20AT33542, 20AT33543, 20AT33544, 20AT33545, 20AT33546, 20AT33547, 20AT33548, 20AT33569, 20AT33570, 20AT33571, 20BT33856, 20BT33857, 20BT33858, 20BT33859, 20BT33860, 20BT33861, 20BT33862, 20BT33863, 20BT33864, 20BT33865, 20BT33866, 20BT33878, 20BT33879, 20BT33880, 20BT33881, 20BT33882, 20BT33883, 20BT33884, 20BT33885, 20BT33886, 20BT33887, 20BT33888, 20BT33889, 20BT34357, 20BT34358, 20BT34359, 20BT34360, 20BT34379, 20BT34380, 20BT34381, 20BT34382, 20BT34383, 20BT34384, 20BT34385, 20BT34386, H2008427, G1923903, G1923904, G1923905, G1923933, G1923934, G1923935, G1923936, G1923964, G1923965, G1923966, G1923967, G1923992, G1923993, G1923994, G1924450, G1924451, G1924452, G1924453, G1924480, G1924481, G1924482, G1924483, G1924512, G1924513, G1924514, G1924543, G1924544, G1924545, G1924571, G1924572, G1924573, G1925072, G1925073, G1925074, G1925075, G1925102, G1925106, G1925107, G1925108, G1925109, G1925137, G1925138, G1925139, G1925140, G1925165, G1925166, G1925167, G1925168, G1925194, G1925195, G1925622, G1925623, G1925624, G1925625, G1925651, G1925652, G1925653, G1925654, G1925682, G1925683, G1925684, G1925685, G1925712, G1925713, G1925714, G1925715, G1925741, G1925742, G1926271, G1926272, G1926273, G1926274, G1926301, G1926302.
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 21, 2020

Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.

Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.

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

Recall #:
86380
Lot/product code:
Mfr. Lot No. EM20AP01, EM20AP02, EM20AP03, EM20MA01
Recalling firm:
BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 22, 2020

CombiDiagnost R90 Software Version R1.0 and R1.1

Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.

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

Recall #:
88393
Lot/product code:
Model 706100
Recalling firm:
Philips Medical Systems Gmbh, DMC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 22, 2020

POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.

Multiple lots being recalled due to a product design issue

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

Recall #:
86099
Lot/product code:
Serial Numbers: A56281, A57539, A58660, A600630, A61590, A62616 & A62689
Recalling firm:
Smith & Nephew Orthopaedics AG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2020

NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).

During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.

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

Recall #:
86150
Lot/product code:
Item Number: PA1160-10D400-7 Description: ANTE FEMUR TROCH 10DEG11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9011815AAA 9021510AAA 9022225AAA 9072512AAA  Item Number: PA1161-10D400-7 Description: ANTE FEMUR TROCH 10DEG13MM X 400MM, 7/10CM ST Lot/Serial Number: 9012506AAA 9061720AAA  Item Number: PA1160-10SJ360-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9013007AAA 9030706AAA 9031514AAA 9042208AAA 9050811AAA 9072218AAA  Item Number: PA1159-10SJ360-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 360MM, 7/10CM STK Lot/Serial Number: 9020607AAA 9022815AAA 9050211AAA 9071604AAA  Item Number: PA1160-90SJ340-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 340MM, 7/9CM ST Lot/Serial Number: 9020608AAA 9052110AAA 9052906AAA 9072217AAA  Item Number: PA1160-80SJ320-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 320MM, 7/8CM ST Lot/Serial Number: 9021222AAA  Item Number: PA1159-80SJ320-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 320MM, 7/8CM STK Lot/Serial Number: 9021223AAA  Item Number: PA1160-70SJ300-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 300MM, 7/7CM ST Lot/Serial Number: 9021224AAA  Item Number: PA1160-10D380-7 Description: ANTE FEMUR TROCH 10DEG11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9021512AAA 9072513AAA 9072912AAA 9080106AAA  Item Number: PA1159-90SJ340-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 340MM, 7/9CM STK Lot/Serial Number: 9020609AAA 9052208AAA 9071603AAA  Item Number: PA1161-10X380-7 Description: RETRO FEMUR STRAIGHT13MM X 380MM, 7/10CM ST Lot/Serial Number: 9021913AAA  Item Number: PA1160-10X360-7 Description: RETRO FEMUR STRAIGHT11.5MM X 360MM, 7/10CM ST Lot/Serial Number: 9022227AAA  Item Number: PA1161-10X360-7 Description: RETRO FEMUR STRAIGHT13MM X 360MM, 7/10CM ST Lot/Serial Number: 9022226AAA  Item Number: PA1160-10SJ400-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9020809AAA  Item Number: PA1159-10SJ400-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 400MM, 7/10CM STK Lot/Serial Number: 9020810AAA  Item Number: PA1160-10SJ380-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9022813AAA 9042506AAA  Item Number: PA1160-10B380-7 Description: ANTE FEMUR PIRIFOMIS11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9021513AAA  Item Number: PA1160-10B360-7 Description: ANTE FEMUR PIRIFOMIS11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9021514AAA  Item Number: PA1159-10SJ380-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 380MM, 7/10CM STK Lot/Serial Number: 9031310AAA 9071605AAA  Item Number: PA1160-10D360-7 Description: ANTE FEMUR TROCH 10DEG11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9022816AAA  Item Number: PA1160-60SJ280-6 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 280MM, 6/6CM ST Lot/Serial Number: 9021914AAA  Item Number: PA1159-70SJ300-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 300MM, 7/7CM STK Lot/Serial Number: 9021915AAA  Item Number: PA1160-90X340-7 Description: RETRO FEMUR STRAIGHT11.5MM X 340MM, 7/9CM ST Lot/Serial Number: 9041617AAA  Item Number: PA1160-10X380-7 Description: RETRO FEMUR STRAIGHT11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9041618AAA  Item Number: PA1159-10D380-7 Description: ANTE FEMUR TROCH 10DEG10MM X 380MM, 7/10CM STK Lot/Serial Number: 9042211AAA  Item Number: PA1161-10B380-7 Description: ANTE FEMUR PIRIFOMIS13MM X 380MM, 7/10CM ST Lot/Serial Number: 9052305AAA 9061009AAA  Item Number: PA1161-10B400-7 Description: ANTE FEMUR PIRIFOMIS13MM X 400MM, 7/10CM ST Lot/Serial Number: 9052306AAA  Item Number: PA1160-10B400-7 Description: ANTE FEMUR PIRIFOMIS11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9053110AAA  Item Number: PA1160-10X400-7 Description: RETRO FEMUR STRAIGHT11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9061208AAA  Item Number: PA1161-10X400-7 Description: RETRO FEMUR STRAIGHT13MM X 400MM, 7/10CM ST Lot/Serial Number: 9061209AAA  Item Number: PA1161-10B400-7 Description: ANTE FEMUR PIRIFOMIS13MM X 400MM, 7/10CM ST Lot/Serial Number: 9061008AAA  Item Number: PA1159-80X320-7 Description: RETO FEMUR STRAIGHT10MM X 320MM, 7/8CM STK Lot/Serial Number: 9062416AAA  Item Number: PA1161-10D380-7 Description: ANTE FEMUR TROCH 10DEG13MM X 380MM, 7/10CM ST Lot/Serial Number: 9061721AAA 9071825AAA  Item Number: PA1159-10B400-7 Description: ANTE FEMUR PIRIFORMIS10MM X 400MM, 7/10CM STK Lot/Serial Number: 9072219AAA  Item Number: PA1159-10D400-7 Description: ANTE FEMUR TROCH 10DEG10MM X 400MM, 7/10CM STK Lot/Serial Number: 9072220AAA 9072911AAA  Item Number: PA1159-10B380-7 Description: ANTE FEMUR PIRIFORMIS10MM X 380MM, 7/10CM STK Lot/Serial Number: 9072221AAA
Recalling firm:
Nuvasive Specialized Orthopedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

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▸Full report

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

Recall #:
86009
Lot/product code:
Instruction Manual Version: 01/2020
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

ALL 50 STATES
▸Full report

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

Recall #:
86009
Lot/product code:
Instruction Manual Version: 08/2018
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

ALL 50 STATES
▸Full report

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

Recall #:
86009
Lot/product code:
Instruction Manual Version: 01/2020
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

ALL 50 STATES
▸Full report

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

Recall #:
86009
Lot/product code:
Instruction Manual Version: 08/2018
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Potential Endotoxin Contamination

ALL 50 STATES
▸Full report

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

Recall #:
85823
Lot/product code:
Kit Lot Number:  3000079504 3000051211 3000051213 3000051214 3000051215 3000051216 3000051217 3000055314 3000056699 3000057319 3000057968 3000058129 3000062638 3000064726 3000068107 3000068108 3000071286 3000072715 3000072716 3000087745 3000090529 3000090660 3000092776 3000076631 3000077754 3000077755 3000080370 3000080371 3000080372 3000080373 3000080374 3000080375 3000080369 3000083330 3000084963 3000084964 3000092777 3000092778 3000095472 3000096375 3000096377 3000096378 3000098752 3000099588 3000099589
Recalling firm:
Datascope Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Potential Endotoxin Contamination

ALL 50 STATES
▸Full report

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

Recall #:
85823
Lot/product code:
Kit Lot Number:  3000053317 3000056694 3000057318 3000057970 3000062073 3000062639 3000062640 3000068106 3000071287 3000072717 3000064723 3000072718 3000072719 3000074886 3000087744 3000090528 3000076632 3000078856 3000080307 3000083331 3000084962 3000092774 3000092775 3000095473 3000096376 3000096606 3000096379 3000098751 3000104521 3000115011
Recalling firm:
Datascope Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces

Test results revealed that the KN95 masks failed to filter greater than 95% of particulates.

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

Recall #:
86241
Lot/product code:
SKU 4555098 & 8510447
Recalling firm:
Office Depot Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

ALL 50 STATES
▸Full report

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

Recall #:
86009
Lot/product code:
Instruction Manual Version: 08/2018
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.

Sample leaking from the sleeve covering the needle inside the cannula

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

Recall #:
86128
Lot/product code:
Lot # A19073FK
Recalling firm:
C.A. Greiner & Sohne Gesellschaftmbh
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Potential Endotoxin Contamination

ALL 50 STATES
▸Full report

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

Recall #:
85823
Lot/product code:
Kit Lot Number:  3000046316 3000047161 3000047162 3000048615 3000049262 3000049914 3000050929 3000051380 3000052645 3000054090 3000055099 3000056537 3000059946 3000061447 3000062406 3000065986 3000066489 3000066764 3000066770 3000068730 3000069160 3000069376 3000071293 3000071739 3000073191 3000073277 3000074271 3000075134 3000075676 3000076957 3000079650 3000081778 3000084071 3000084788 3000084789 3000086924 3000085291 3000087368 3000088278 3000088570 3000090526 3000090664 3000092443 3000096052 3000097302 3000098997 3000101522 3000103209 3000106823 3000110212 3000111023 3000112113 3000058895 3000064045 3000073190 3000077204 3000084689 3000086162 3000089349 3000094526 3000103212 3000110211 3000046315 3000047053 3000047709 3000048710 3000049479 3000050215 3000050930 3000051379 3000052646 3000054089 3000055098 3000056438 3000060258 3000060259 3000061292 3000063264 3000064522 3000066679 3000065125 3000065984 3000065985 3000066515 3000066680 3000067692 3000069161 3000069872 3000069873 3000071217 3000071891 3000073192 3000074272 3000075133 3000076154 3000076956 3000079648 3000079649 3000080226 3000081779 3000083059 3000084153 3000086058 3000087369 3000088277 3000089284 3000090665 3000092442 3000094528 3000094531 3000096053 3000096054 3000098998 3000098999 3000101523 3000103210 3000106825 3000107337 3000111022 3000112114 3000046411 3000069162 3000069442 3000071837 3000094141 3000111134 3000094151 3000094527 3000096001 3000099000 3000103211 3000106824 3000107336 3000111191 3000112115
Recalling firm:
Datascope Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Potential Endotoxin Contamination

ALL 50 STATES
▸Full report

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

Recall #:
85823
Lot/product code:
Kit Lot Number:  3000049797 3000053552 3000056193 3000056201 3000057749 3000066195 3000067965 3000069878 3000071222 3000072585 3000074287 3000078937 3000079446 3000080540 3000084470 3000090372 3000092553 3000095910 3000099930 3000103632 3000112148 3000053297 3000057125 3000072586 3000049798 3000053553 3000057748 3000061193 3000066264 3000069270 3000071221 3000072584 3000074288 3000077341 3000077814 3000083060 3000084471 3000087477 3000087478 3000088619 3000090373 3000092552 3000095911 3000099932 3000103631 3000053554 3000056540 3000061194 3000068728 3000092554 3000095912 3000099933 3000102246 3000049800 3000074289 3000092555 3000099931
Recalling firm:
Datascope Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Potential Endotoxin Contamination

ALL 50 STATES
▸Full report

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

Recall #:
85823
Lot/product code:
Kit Lot Number:  3000045657 3000047164 3000048708 3000049477 3000050927 3000051753 3000051754 3000052790 3000053815 3000053816 3000056436 3000058893 3000059906 3000063263 3000064521 3000065233 3000066677 3000067689 3000071413 3000072399 3000074269 3000075922 3000077813 3000080874 3000081078 3000083096 3000084472 3000084787 3000086850 3000087366 3000088618 3000089991 3000090768 3000094337 3000097300 3000098247 3000099929 3000102977 3000106755 3000110208 3000111136 3000058894 3000070665 3000073189 3000077203 3000080875 3000084690 3000086792 3000089348 3000094338 3000103213 3000110209 3000045656 3000047710 3000048709 3000049478 3000050926 3000051752 3000052791 3000053817 3000056437 3000059907 3000061290 3000061291 3000064520 3000065234 3000065987 3000066678 3000067690 3000068924 3000069876 3000071218 3000071977 3000071978 3000073188 3000074270 3000076924 3000077812 3000080877 3000081077 3000083095 3000086851 3000087367 3000088617 3000090767 3000092537 3000094336 3000097301 3000098248 3000099928 3000102978 3000106754 3000110207 3000111137 3000046410 3000083097 3000111135 3000103214 3000110210 3000111192
Recalling firm:
Datascope Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

ALL 50 STATES
▸Full report

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

Recall #:
86009
Lot/product code:
Instruction Manual Version: 08/2018
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)