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Recalls affecting North Carolina

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

17,271 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

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

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

Full report

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.

ALL 50 STATES
Full report

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.

ALL 50 STATES
Full report

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

ALL 50 STATES
Full report

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.

ALL 50 STATES
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)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Potential Endotoxin Contamination

ALL 50 STATES
Full report

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

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

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

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

Sample leaking from the sleeve covering the needle inside the cannula

ALL 50 STATES
Full report

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

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

Datascope Intra-Aortic Ballon Catheters (IABs)-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

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - 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:  3000108682 3000108683 3000109819 3000110955 3000111683 3000111684 3000112929 3000112930 3000113624 3000113625 3000117020 3000046749 3000094529 3000094530 3000103206 3000104388 3000108351 3000112932
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 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- 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:  3000066986 3000069732 3000077731 3000077732 3000080305 3000083332 3000083333 3000084968 3000087492 3000095469 3000096180 3000096181 3000096585 3000098052 3000103498 3000104616 3000104617 3000112275 3000113067
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 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
Full report

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

Potential Endotoxin Contamination

ALL 50 STATES
Full report

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

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

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10

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:  3000046733 3000047274 3000047604 3000048401 3000049310 3000051066 3000051995 3000053048 3000054067 3000054914 3000057090 3000058631 3000059460 3000060261 3000060731 3000060848 3000062743 3000064057 3000071409 3000065401 3000065942 3000066768 3000067500 3000068688 3000068689 3000070070 3000072315 3000072885 3000083860 3000075682 3000076775 3000079570 3000080053 3000077520 3000077941 3000078503 3000078600 3000078656 3000079242 3000080764 3000081888 3000082186 3000082885 3000083861 3000084565 3000084851 3000085193 3000087974 3000088594 3000088639 3000089730 3000090853 3000091126 3000091327 3000092503 3000093663 3000095290 3000095946 3000096738 3000097654 3000099417 3000100344 3000101784 3000103915 3000105898 3000106317 3000109026 3000111350 3000111973 3000048959 3000047353 3000047706 3000048026 3000048961 3000048960 3000048962 3000050258 3000051647 3000052948 3000054290 3000054291 3000054967 3000056074 3000057384 3000058896 3000058897 3000060262 3000060733 3000063082 3000063083 3000064046 3000066141 3000066142 3000066284 3000067688 3000069656 3000069657 3000070408 3000070664 3000071058 3000071414 3000073065 3000073403 3000075684 3000079569 3000080103 3000077273 3000077519 3000078683 3000080104 3000080443 3000080782 3000082659 3000083600 3000085381 3000086267 3000087315 3000089459 3000090849 3000092396 3000093113 3000094005 3000095038 3000095945 3000098249 3000100378 3000102536 3000103919 3000106447 3000109023 3000110738 3000115116 3000116665 3000047198 3000047708 3000049208 3000049723 3000051122 3000052154 3000052155 3000053152 3000053792 3000054880 3000056191 3000056936 3000057345 3000058847 3000060260 3000060587 3000063258 3000064097 3000065030 3000065853 3000065943 3000066282 3000067497 3000068770 3000069317 3000070409 3000070410 3000071410 3000072886 3000072916 3000075681 3000076776 3000075131 3000079466 3000080054 3000077522 3000077523 3000077524 3000078051 3000078684 3000080537 3000080783 3000081157 3000083094 3000083092 3000083093 3000080538 3000084692 3000085501 3000085502 3000087316 3000087317 3000087975 3000088620 3000089731 3000090848 3000091184 3000091328 3000093664 3000095289 3000097650 3000099419 3000098615 3000099420 3000100266 3000101785 3000103920 3000105895 3000106449 3000106450 3000109025 3000110414 3000111358 3000111359 3000116581 3000046737 3000047275 3000047637 3000048223 3000048400 3000049421 3000049722 3000050669 3000051151 3000051152 3000052046 3000053049 3000054337 3000054915 3000057067 3000057385 3000057386 3000058630 3000060734 3000062028 3000062697 3000065235 3000065854 3000066769 3000067531 3000067532 3000067533 3000067891 3000068434 3000068731 3000069377 3000070489 3000071411 3000072230 3000072884 3000073275 3000075683 3000075675 3000075963 3000077521 3000077940 3000078502 3000078601 3000079315 3000079829 3000078934 3000080098 3000080780 3000082187 3000085290 3000087124 3000087976 3000088621 3000090854 3000091039 3000091040 3000091477 3000093115 3000095291 3000095796 3000097651 3000097652 3000098613 3000099418 3000100066 3000100346 3000101786 3000106316 3000108557 3000109401 3000110454 3000110735 3000115917 3000097096 3000046499 3000047201 3000049313 3000054879 3000056192 3000058580 3000062803 3000065029 3000065852 3000066283 3000069316 3000070488 3000072248 3000076777 3000075132 3000079467 3000079941 3000078050 3000080781 3000085503 3000088490 3000089725 3000090855 3000093675 3000097057 3000100067 3000101787 3000105897 3000109024 3000066139 3000067810 3000071126 3000072259 3000083859 3000077205 3000079828 3000082126 3000080463 3000084652 3000085504 3000087161 3000100856 3000103052 3000103053 3000107166 3000107281 3000107909 3000110205 3000046814 3000047059 3000056260 3000061584 3000076778 3000081156 3000100000 3000101129 3000101130 3000094152 3000095152 3000096000 3000097653 3000103055 3000103916 3000105384 3000106448 3000109400 3000116582 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)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Flexible DCI Intubation Fiberscope, Part: 11301BND1, 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)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Potential Endotoxin Contamination

ALL 50 STATES
Full report

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

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

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)-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)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

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

Potential Endotoxin Contamination

ALL 50 STATES
Full report

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

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

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

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

JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces

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

ALL 50 STATES
Full report

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

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

Flexible Intubation Fiberscope, Part: 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)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - 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)