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Recalls affecting Pennsylvania

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

17,247 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

View FDA’s announcement (opens in a new tab)
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

Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares 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 #: M00562401 Inner Package UPN #: M00562400 GTIN: 08714729019411 Lot #s: 25321152, 25338467, 25426642 Expiration Dates: 6-Mar-23 through 31-Mar-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

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 #: M00562402 Inner Package UPN #: M00562400 GTIN: 08714729501640 Lot #s: 25111007, 25133479, 25142120, 25299896, 25351474, 25357539, 25402321 Expiration Dates: 28-Jan-23 through 24-Mar- 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 #: M00561311 Inner Package UPN #: M00561310 GTIN: 08714729019251 Lot #s: 25199777, 25330546, 25374640, 25424470,  Expiration Dates: 11-Feb-23 through 31-Mar-23
Recalling firm:
Boston Scientific Corporation
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
▸Full report

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 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, 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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) 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) 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 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.

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▸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 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
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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

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Potential Endotoxin Contamination

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

Recall #:
85823
Lot/product code:
Kit Lot Number:  3000102215 3000102248 3000102249 3000103405 3000103406 3000105261 3000105262 3000106963 3000107331 3000107332 3000108589 3000108881 3000110520 3000111682 3000113810 3000046748 3000102329 3000103404
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)-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)-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 Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - 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:  3000045349 3000051218 3000053318 3000055309 3000055310 3000055311 3000056703 3000057316 3000057317 3000057967 3000066213 3000066214 3000068109 3000068110 3000068111 3000069731 3000071412 3000072401 3000072402 3000073682 3000073816 3000073817 3000074887 3000083328 3000083329 3000087746 3000076462 3000078855 3000079319 3000079320 3000083326 3000080308 3000083327 3000087747 3000090530 3000090531 3000092773 3000096367 3000096368 3000095471 3000096369 3000096370 3000096371 3000096372 3000096373 3000096374 3000098749 3000098750 3000103503 3000103504 3000103505 3000103506 3000110580 3000110581 3000110582 3000110583 3000110584 3000113008 3000113009 3000113148 3000115015
Recalling firm:
Datascope Corporation
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 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

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 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:  3000046414 3000047431 3000048243 3000049080 3000049569 3000050495 3000051154 3000051751 3000053311 3000054591 3000054592 3000056356 3000056629 3000058277 3000060542 3000064249 3000066800 3000065563 3000067963 3000070668 3000071291 3000071979 3000073516 3000074146 3000075999 3000078921 3000080138 3000080137 3000081624 3000082197 3000082848 3000083430 3000084785 3000086995 3000087888 3000089898 3000091753 3000092239 3000092240 3000094450 3000094451 3000095604 3000096970 3000097957 3000100722 3000105063 3000102628 3000105064 3000107101 3000108962 3000109818 3000112782 3000046415 3000047430 3000048245 3000049085 3000049570 3000051153 3000051881 3000053310 3000054729 3000056538 3000059168 3000059618 3000060730 3000060451 3000064248 3000066798 3000065636 3000066799 3000067964 3000070669 3000071292 3000071980 3000073517 3000074144 3000074145 3000076000 3000078922 3000080140 3000082847 3000083431 3000083989 3000084730 3000087112 3000088376 3000089899 3000091754 3000092134 3000094449 3000095692 3000096971 3000097952 3000097953 3000100721 3000102697 3000105062 3000107100 3000109817 3000111681 3000113153 3000048244 3000049567 3000050496 3000051155 3000053312 3000054730 3000059169 3000060545 3000060543 3000066063 3000064842 3000064843 3000066801 3000066802 3000066803 3000076001 3000080543 3000080544 3000081621 3000082189 3000084786 3000086996 3000091755 3000092238 3000097956 3000102698 3000105060 3000106965 3000112155 3000112156 3000046416 3000047435 3000049568 3000056539 3000059619 3000064250 3000066804 3000066805 3000067857 3000070670 3000073518 3000074162 3000078923 3000080139 3000084731 3000097954 3000102699 3000108432 3000112154 3000103022 3000047356 3000048230 3000049055 3000051378 3000054590 3000056355 3000056628 3000059148 3000060544 3000068926 3000068941 3000073404 3000074166 3000074890 3000076131 3000076402 3000078920 3000080420 3000081777 3000083598 3000085937 3000090852 3000089347 3000091872 3000094108 3000094935 3000096067 3000095318 3000096066 3000097959 3000100857 3000100582 3000102905 3000105061 3000107102 3000108963 3000111680 3000113152 3000068029 3000071836 3000074163 3000103039 3000106964
Recalling firm:
Datascope Corporation
View official FDA record (opens in a new tab)