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Recalls affecting Wisconsin

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

16,927 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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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

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)
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.

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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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 6, 2020

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

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

Recall #:
86004
Lot/product code:
Outer Package UPN #: M00561291 Inner Package UPN #: M00561290 GTIN: 08714729645801 Lot #s: 25170944, 25219286, 25368742, 25412118, 25508371 Expiration Dates: 5-Feb-23 through 13-May-23
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2020

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

ALL 50 STATES
▸Full report

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

Recall #:
86004
Lot/product code:
Outer Package UPN #: M00562321 Inner Package UPN #: M00562320 GTIN: 08714729019336 Lot #s: 25158564, 25245733, 25245735, 25330549, 25403001, 25439073, 25513671 Expiration Dates: 4-Feb-23 through 14-May-23
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2020

Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053

Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device

ALL 50 STATES
▸Full report

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

Recall #:
86027
Lot/product code:
Lot Number: 108332-A  UDI: (01)0084113212400(10)108332A
Recalling firm:
OrthoPediatrics Corp
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2020

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

ALL 50 STATES
▸Full report

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

Recall #:
86004
Lot/product code:
Outer Package UPN #: M00562341 Inner Package UPN #: M00562340 GTIN: 08714729019350 Lot #s: 25077093, 25164173, 25185062, 25187234, 25226123, 25255681, 25336754, 25403003, 25508379, 25524901 Expiration Dates: 20-Jan-23 through 14-May-23
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 8, 2020

System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147

During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.

CACTIDLAMTNVOHSCWIWV
▸Full report

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

Recall #:
86077
Lot/product code:
The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041.
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2020

Medtronic SynchroMed, Model A10

The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.

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

Recall #:
93401
Lot/product code:
GTIN 00643169771031, All serial numbers with software version 1.1.300.
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
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.

ALL 50 STATES
▸Full report

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 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, 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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) 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) 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) 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) 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-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 17, 2020

Parvovirus B19 IgG EIA kit Part No. V519IGUS

Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value

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

Recall #:
86152
Lot/product code:
Lot 71440040AA
Recalling firm:
Diasorin 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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▸Full report

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

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01

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:  3000051381 3000053316 3000057969 3000062074 3000066987 3000062557 3000062558 3000066988 3000064524 3000066989 3000066990 3000067890 3000069733 3000074397 3000074398 3000077670 3000077671 3000078857 3000080306 3000080310 3000083334 3000083335 3000084272 3000084969 3000087490 3000087491 3000092779 3000092780 3000095470 3000096586 3000098053 3000098054 3000098055 3000098056 3000099590 3000099591 3000112273 3000107761 3000107762 3000112274
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)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - 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:  3000045568 3000047929 3000047928 3000047930 3000053321 3000060109 3000060110 3000067699 3000062192 3000067700 3000067701 3000069728 3000069729 3000069730 3000071288 3000073187 3000076242 3000077669 3000079105 3000079318 3000080309 3000080876 3000084268 3000084967 3000084960 3000084961 3000086800 3000088372 3000090597 3000090598 3000092668 3000092666 3000092667 3000092669 3000096268 3000095468 3000096267 3000096269 3000096270 3000096271 3000096587 3000098175 3000098747 3000098748 3000102410 3000102411 3000103470 3000104519 3000106011 3000107760 3000110622 3000110623 3000112744 3000113154
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 Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -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:  3000047433 3000048714 3000049793 3000053296 3000054596 3000055303 3000056631 3000060227 3000064257 3000070321 3000071835 3000072581 3000072582 3000076925 3000078405 3000079518 3000080107 3000083511 3000084721 3000087689 3000092131 3000092215 3000095792 3000096364 3000097534 3000100872 3000102116 3000106750 3000107623 3000112279 3000047432 3000047933 3000049794 3000052255 3000055306 3000056632 3000061197 3000064258 3000065635 3000066086 3000066265 3000067264 3000067841 3000068601 3000068602 3000074729 3000074850 3000079519 3000081079 3000080541 3000083512 3000084722 3000087474 3000087973 3000089282 3000092129 3000092130 3000095793 3000097645 3000096762 3000097644 3000097643 3000103157 3000104738 3000106751 3000107624 3000112280 3000047434 3000047523 3000048024 3000048025 3000049795 3000052254 3000053295 3000054426 3000054425 3000055305 3000059063 3000060228 3000061341 3000064844 3000072583 3000081622 3000082248 3000082188 3000083990 3000084723 3000099218 3000104736 3000104737 3000106752 3000047309 3000047934 3000049796 3000066797 3000074731 3000083513 3000079520 3000083514 3000095794 3000096366 3000102115 3000106753 3000112278 3000047355 3000048228 3000050257 3000052253 3000054424 3000055304 3000056630 3000059062 3000060229 3000061195 3000061196 3000064259 3000064355 3000066796 3000069443 3000070319 3000080729 3000077201 3000078053 3000078919 3000080419 3000083599 3000084691 3000085499 3000086793 3000086794 3000089346 3000091874 3000090851 3000091873 3000093117 3000093118 3000093119 3000094614 3000094613 3000095319 3000095854 3000096761 3000097533 3000099217 3000100871 3000102117 3000103158 3000104739 3000106898 3000107622 3000112281 3000114254 3000071786 3000073203 3000096365 3000103156
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)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - 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:  3000047804 3000053322 3000053323 3000060107 3000060108 3000062255 3000067698 3000069727 3000071976 3000073186 3000073680 3000073681 3000074885 3000076710 3000076711 3000077752 3000077753 3000079103 3000079104 3000080873 3000080872 3000081671 3000084267 3000084966 3000084965 3000086799 3000088548 3000088371 3000090599 3000090600 3000090601 3000090602 3000090603 3000092664 3000092663 3000092665 3000096263 3000095467 3000096264 3000096265 3000096266 3000098176 3000098177 3000102408 3000102409 3000103469 3000104520 3000104615 3000106012 3000107758 3000107759 3000110626 3000113155 3000112276 3000113156
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: 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

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)