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Recalls affecting Ohio

Data last updated: September 11, 2026 at 1:08 PM UTC

17,229 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 21, 2021

CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.

Device failed to function as intended and/or failed to conform to their design specifications.

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

Recall #:
92206
Lot/product code:
CS 9600
Recalling firm:
Trophy SAS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 22, 2021

EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi

Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system, which could lead to patient or user musculoskeletal injury.

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

Recall #:
88313
Lot/product code:
Manufactured Between 2020-02-27 to 2021-05-25
Recalling firm:
Philips Ultrasound Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 23, 2021

TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

Potential for leaks and loosening at the patient catheter connection

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

Recall #:
88369
Lot/product code:
GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 23, 2021

TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

Potential for leaks and loosening at the patient catheter connection

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

Recall #:
88369
Lot/product code:
GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2021

Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

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

Recall #:
88333
Lot/product code:
Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2021

Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

ALL 50 STATES
▸Full report

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

Recall #:
88333
Lot/product code:
Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2021

Trilogy Evo Universal, Product number DS2000X11B

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

ALL 50 STATES
▸Full report

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

Recall #:
88333
Lot/product code:
Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2021

Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01

Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc.

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

Recall #:
88502
Lot/product code:
Model Number: LN 03R70-01 all units with software versions 3.2.3 and earlier. Serial Numbers manufactured by Sanmina: SCM01001; SCM01002; SCM01003; SCM01004; SCM01005; SCM01006; SCM01007; SCM01008; SCM01009; SCM01010; SCM01011; SCM01012; SCM01013; SCM01014; SCM01015; SCM01016; SCM01017; SCM01018; SCM01019; SCM01020; SCM01021; SCM01022; SCM01023; SCM01024; SCM01025; SCM01026; SCM01027; SCM01028; SCM01029; SCM01030; SCM01031; SCM01032; SCM01033; SCM01034; SCM01035; SCM01036; SCM01037; SCM01038; SCM01039; SCM01040; SCM01041; SCM01042; SCM01043; SCM01044; SCM01045; SCM01046; SCM01047; SCM01048; SCM01049; SCM01050; SCM01051; SCM01052; SCM01053; SCM01054; SCM01055; SCM01056; SCM01057; SCM01058; SCM01059; SCM01060; SCM01061; SCM01062; SCM01063; SCM01064; SCM01065; SCM01066; SCM01067; SCM01068; SCM01069; SCM01070; SCM01071; SCM01072; SCM01073; SCM01074; SCM01075; SCM01076; SCM01077; SCM01078; SCM01079; SCM01080; SCM01081; SCM01082; SCM01083; SCM01084; SCM01085; SCM01086; SCM01087; SCM01088; SCM01089; SCM01090; SCM01091; SCM01092; SCM01093; SCM01094; SCM01095; SCM01096; SCM01097; SCM01098; SCM01099; SCM01100; SCM01101; SCM01102; SCM01103; SCM01104; SCM01105; SCM01106; SCM01107; SCM01108; SCM01109; SCM01110; SCM01112; SCM01113; SCM01114; SCM01115; SCM01116; SCM01117; SCM01118; SCM01119; SCM01120; SCM01121; SCM01122; SCM01123; SCM01124; SCM01125; SCM01126; SCM01127; SCM01128; SCM01129; SCM01130; SCM01131; SCM01132; SCM01133; SCM01134; SCM01135; SCM01136; SCM01137; SCM01138; SCM01139; SCM01140; SCM01141; SCM01142; SCM01143; SCM01144; SCM01145; SCM01146; SCM01147; SCM01148; SCM01149; SCM01150; SCM01151; SCM01152; SCM01153; SCM01154; SCM01155; SCM01156; SCM01157; SCM01158; SCM01159; SCM01160; SCM01161; SCM01162; SCM01163; SCM01164; SCM01165; SCM01166; SCM01167; SCM01168; SCM01169; SCM01170; SCM01171; SCM01172; SCM01173; SCM01174; SCM01175; SCM01176; SCM01177; SCM01178; SCM01179; SCM01180; SCM01181; SCM01182; SCM01183; SCM01184; SCM01185; SCM01186; SCM01187; SCM01188; SCM01189; SCM01190; SCM01191; SCM01192; SCM01193; SCM01194; SCM01195; SCM01196; SCM01197; SCM01198; SCM01199; SCM01200; SCM01201; SCM01202; SCM01203; SCM01204; SCM01205; SCM01206; SCM01207; SCM01208; SCM01209; SCM01210; SCM01211; SCM01212; SCM01213; SCM01214; SCM01215; SCM01216; SCM01217; SCM01218; SCM01219; SCM01220; SCM01221; SCM01222; SCM01223; SCM01224; SCM01225; SCM01226; SCM01227; SCM01228; SCM01229; SCM01230; SCM01231; SCM01232; SCM01234; SCM01235; SCM01236; SCM01237; SCM01238; SCM01239; SCM01240; SCM01241; SCM01242; SCM01243; SCM01244; SCM01245; SCM01246; SCM01247; SCM01248; SCM01249; SCM01250; SCM01251; SCM01252; SCM01253; SCM01254; SCM01255; SCM01256; SCM01257; SCM01258; SCM01259; SCM01260; SCM01261; SCM01262; SCM01263; SCM01264; SCM01265; SCM01266; SCM01267; SCM01268; SCM01269; SCM01270; SCM01271; SCM01272; SCM01273; SCM01274; SCM01275; SCM01276; SCM01277; SCM01278; SCM01279; SCM01280; SCM01281; SCM01282; SCM01283; SCM01284; SCM01285; SCM01286; SCM01287; SCM01288; SCM01289; SCM01290; SCM01291; SCM01292; SCM01293; SCM01294; SCM01295; SCM01296; SCM01297; SCM01298; SCM01299; SCM01300; SCM01301; SCM01302; SCM01303; SCM01304; SCM01305; SCM01306; SCM01307; SCM01308; SCM01309; SCM01310; SCM01311; SCM01312; SCM01313; SCM01314; SCM01315; SCM01316; SCM01317; SCM01318; SCM01319; SCM01320; SCM01321; SCM01322; SCM01323; SCM01324; SCM01325; SCM01326; SCM01327; SCM01328; SCM01329; SCM01330; SCM01331; SCM01332; SCM01333; SCM01334; SCM01335; SCM01336; SCM01337; SCM01338; SCM01339; SCM01340; SCM01341; SCM01342; SCM01343; SCM01344; SCM01345; SCM01346; SCM01347; SCM01348; SCM01349; SCM01350; SCM01351; SCM01352; SCM01353; SCM01354; SCM01355; SCM01356; SCM01357; SCM01358; SCM01359; SCM01360; SCM01361; SCM01362; SCM01363; SCM01364; SCM01365; SCM01366; SCM01367; SCM01368; SCM01369; SCM01370; SCM01371; SCM01372; SCM01373; SCM01374; SCM01375; SCM01376; SCM01377; SCM01378; SCM01379; SCM01380; SCM01381; SCM01382; SCM01383; SCM01384; SCM01385; SCM01386; SCM01387; SCM01388; SCM01389; SCM01390; SCM01391; SCM01392; SCM01393; SCM01394; SCM01395; SCM01396; SCM01397; SCM01399; SCM01400; SCM01401; SCM01402; SCM01403; SCM01404; SCM01405; SCM01406; SCM01407; SCM01408; SCM01409; SCM01410; SCM01411; SCM01412; SCM01413; SCM01414; SCM01415; SCM01416; SCM01417; SCM01418; SCM01419; SCM01420; SCM01421; SCM01422; SCM01423; SCM01424; SCM01425; SCM01426; SCM01427; SCM01428; SCM01429; SCM01430; SCM01431; SCM01432; SCM01433; SCM01434; SCM01435; SCM01436; SCM01437; SCM01438; SCM01439; SCM01440; SCM01441; SCM01442; SCM01443; SCM01444; SCM01445; SCM01446; SCM01447; SCM01448; SCM01449; SCM01450; SCM01451; SCM01452; SCM01453; SCM01454; SCM01455; SCM01456; SCM01457; SCM01458; SCM01459; SCM01460; SCM01461; SCM01462; SCM01463; SCM01464; SCM01465; SCM01466; SCM01467; SCM01468; SCM01469; SCM01470; SCM01471; SCM01472; SCM01473; SCM01474; SCM01475; SCM01476; SCM01477; SCM01478; SCM01479; SCM01480; SCM01481; SCM01482; SCM01483; SCM01484; SCM01485; SCM01486; SCM01487; SCM01488; SCM01489; SCM01490; SCM01491… (truncated, 53936 characters total — see the official FDA record for the full value)
Recalling firm:
Abbott Laboratories
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2021

Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

ALL 50 STATES
▸Full report

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

Recall #:
88333
Lot/product code:
Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2021

REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.

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▸Full report

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

Recall #:
88473
Lot/product code:
Lot/Serial Number - Exp. Date: 963162 6/30/2021; 967672 6/30/2021; 978229 7/31/2021; 986594 7/31/2021; 988075 7/31/2021; 991067 8/31/2021; 994373 8/31/2021; 996570 8/31/2021; 998004 8/31/2021; 998332 8/31/2021; 1000061 8/31/2021; 1004858 9/30/2021; 1005204 9/30/2021; 1007650 9/30/2021; 1010791 9/30/2021; 1013939 9/30/2021; 1017379 10/31/2021; 1035580 11/30/2021; 1035581 11/30/2021; 1038740 11/30/2021; 1044131 12/31/2021; 1049259 12/31/2021; 1050881 12/31/2021; 1052628 12/31/2021; 1057742 1/31/2022; 1059045 1/31/2022; 1061515 1/31/2022; 1065338 1/31/2022; 1066413 1/31/2022; 1066484 1/31/2022; 1068754 2/28/2022; 1069385 2/28/2022; 1072036 2/28/2022; 1072932 2/28/2022; 1076214 2/28/2022; 1078134 2/28/2022; 1078406 2/28/2022; 1080547 2/28/2022; 1082456 2/28/2022; 1085984 3/31/2022; 1086606 3/31/2022; 1087768 3/31/2022; 1088480 3/31/2022; 1089329 3/31/2022; 1089500 3/31/2022; 1090412 3/31/2022; 1092057 3/31/2022; 1094384 3/31/2022; 1095382 4/30/2022; 1097231 4/30/2022; 1097282 4/30/2022; 1098267 4/30/2022; 1099427 4/30/2022; 1102009 4/30/2022; 1109455 5/31/2022; 1110142 5/31/2022; 1112821 5/31/2022; 1113754 5/31/2022; 1116187 5/31/2022; 1121054 5/31/2022; 1122273 6/30/2022; 1125711 6/30/2022; 1125917 6/30/2022; 1127492 6/30/2022; 1127964 6/30/2022; 1129544 6/30/2022; 1130696 6/30/2022; 1132694 6/30/2022; 1137174 7/31/2022; 1138050 7/31/2022; 1142149 7/31/2022; 1143470 7/31/2022; 1143855 7/31/2022; 1144660 7/31/2022; 1146743 7/31/2022; 1150183 8/31/2022; 1151530 8/31/2022; 1152049 8/31/2022; 1152438 8/31/2022; 1153264 8/31/2022; 1155379 8/31/2022; 1155518 8/31/2022; 1155992 8/31/2022; 1158661 8/31/2022; 1159859 8/31/2022; 1161713 9/30/2022; 1164223 9/30/2022; 1166044 9/30/2022; 1167036 9/30/2022; 1167227 9/30/2022; 1167956 9/30/2022; 1169993 9/30/2022; 1180039 10/31/2022; 1189176 11/30/2022; 1190023 11/30/2022; 1190032 11/30/2022; 1194421 11/30/2022; 1194422 11/30/2022; 1198084 12/31/2022; 1198085 12/31/2022; 1200458 12/31/2022; 1200657 12/31/2022; 1202859 12/31/2022; 1204663 12/31/2022; 1206730 12/31/2022; 1209231 12/31/2022; 1210383 1/31/2023; 1210987 1/31/2023; 1213059 1/31/2023; 1214083 1/31/2023; 1214808 1/31/2023; 1217214 2/28/2023; 1218641 2/28/2023; 1220580 2/28/2023; 1221532 2/28/2023; 1230001 3/31/2023; 1234242 4/30/2023; 1234866 4/30/2023; 1237066 4/30/2023; 1239250 4/30/2023; 1241484 5/31/2023; 1243238 5/31/2023; 1245024 5/31/2023; 1250142 6/30/2023; 1253967 7/31/2023; 1255153 7/31/2023; 1256826 7/31/2023; 1257665 7/31/2023; 1260624 8/31/2023; 1261698 8/31/2023; 1263690 8/31/2023; 1268443 9/30/2023; 1269717 9/30/2023; 1276374 11/30/2023; 1276474 11/30/2023; 1277076 11/30/2023; 1277078 11/30/2023; 1278052 11/30/2023; 1279629 12/31/2023; 1280551 12/31/2023; 1281423 12/31/2023; 1282441 12/31/2023; 1282566 12/31/2023; 1285959 1/31/2024; 1289325 1/31/2024; 1290116 2/29/2024; 1290526 2/29/2024; 1290901 2/29/2024; 1291368 2/29/2024; 1291991 2/29/2024; 1293285 2/29/2024; 1293713 2/29/2024; 1294738 3/31/2024; 1296369 3/31/2024; 1297347 3/31/2024; 1298132 3/31/2024; 1299347 4/30/2024; 1302001 4/30/2024; 1302770 4/30/2024; 1304508 4/30/2024; 1305180 5/31/2024; 1306210 5/31/2024; 1306618 6/30/2024; 1307348 5/31/2024; 1308370 5/31/2024; 1309271 6/30/2024; 1310700 6/30/2024; 1312765 6/30/2024; 1313035 6/30/2024; 1313638 6/30/2024; 1315612 7/31/2024; 1319007 8/31/2024; 1321484 8/31/2024; 1321909 8/31/2024; 1323424 9/30/2024; 1324561 9/30/2024; 1325914 9/30/2024; 1326666 9/30/2024; 1328546 10/31/2024; 1328868 10/31/2024; 1330383 10/31/2024; 1331229 11/30/2024; 1334317 11/30/2024; 1335560 11/30/2024; 1336948 12/31/2024; 1346946 2/28/2025; 1350086 2/28/2025; 1352112 2/28/2025; 1353076 2/28/2025; 1354658 3/31/2025; 1355795 3/31/2025; 1356579 3/31/2025; 1364166 5/31/2025; 1370390 6/30/2025; 1371002 6/30/2025; 1372716 6/30/2025; 1372717 6/30/2025; 1373632 6/30/2025; 1374321 6/30/2025; 1374720 6/30/2025; 1376484 7/31/2025; 1376558 7/31/2025; 1378293 7/31/2025; 1379114 7/31/2025; 1379319 7/31/2025; 1379975 7/31/2025; 1380313 7/31/2025; 1382427 8/31/2025; 1382905 8/31/2025; 1383730 8/31/2025; 1384557 8/31/2025; 1389054 9/30/2025; 1389688 9/30/2025; 1389835 9/30/2025; 1390329 10/31/2025; 1392449 10/31/2025; 1392925 10/31/2025; 1393712 10/31/2025; 1395327 11/30/2025; 1396203 11/30/2025; 1397019 11/30/2025; 1397577 11/30/2025; 1397579 11/30/2025; 1399709 12/31/2025; 1401245 1/31/2026; 1402635 1/31/2026; 1403128 1/31/2026; 1404960 1/31/2026; 1405506 1/31/2026; 1408600 2/28/2026; 1409355 2/28/2026; 1411640 3/31/2026; 1412991 3/31/2026; 1414301 4/30/2026; 1414832 4/30/2026; 1416059 4/30/2026; 1417013 4/30/2026; 1418166 4/30/2026; 1418927 5/31/2026; 1419365 5/31/2026; 1420607 5/31/2026
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 28, 2021

Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116

Missing splash guard which may expose users to hazardous materials. .

ALL 50 STATES
▸Full report

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

Recall #:
88615
Lot/product code:
Catalog Number: A88116 - 3K HS Refrigerated Stockyard UDI: 15099590591960 Serial Numbers: 90HF1304006; 90HF1306009; 90HF1303005; 90HF1508005; 90HF1302005; 90HF1610005; 90HF1806001; 90HF1209005; 90HF1303007; 90HF1708006; 90HF1205001; 90HF1805002; 90HF1402005; 90HF1503001; 90HF1104002; 90HF1208004; 90HF1208005; 90HF1203001; 90HF1012004; 90HF1101002; 90HF1702003; 90HF1402004; 90HF1303008; 90HF1210001; 90HF1207001; 90HF1305007; 90HF1305004; 90HF1610001; 90HF1505002; 90HF1307005; 90HF1610002; 90HF1508003; 90HF1210002; 90HF1306001; 90HF1206002; 90HF1208002; 90HF1305008; 90HF1009002; 90HF1101001; Catalog Number: 6915556 - Power Processor 3K Stockyard (Stockyard 3000/R Kit for PWR PROC) Serial Numbers: 90AM0805001; 90AM0902009; 90AM0902005; 90AM0806003; 90AM0801003; 90AM0802002; 90AM0803001; 90AM0912002; 90AM1003002; 90AM0905010; 90AM0801004; 90AM06007008; 90AM060703; 90AM060704; 90AM0710002; 90AM0905007; 90AM0710008; 90AM0903002; 90AM0808002; 90AM0711004; 90AM0711005; 90AM0810001; 90AM0901002; 90AM0905006; 90AM0904004; 90AM0904005; 90AM0803002; 90AM0710004; Amended - additional Products and Codes (12/15/2021): B05520 - Stockyard, 5K HS, Refrigerated Serial Numbers: 90HG1104002; 90HG1101001; 90HG1105002; 90HG1104001; 90HG1101003; 90HG1101002; 90HG1202004; 90HG1102005; 90HG1101004; 90HG1206002; A88115 - 5K HS Refrig Stockyard Serial Numbers: 90HG0911001 90HG0911003 90HG0911002
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 28, 2021

Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

ALL 50 STATES
▸Full report

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

Recall #:
88362
Lot/product code:
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Recalling firm:
Roche Diabetes Care, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 28, 2021

Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

ALL 50 STATES
▸Full report

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

Recall #:
88362
Lot/product code:
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Recalling firm:
Roche Diabetes Care, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 28, 2021

Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

ALL 50 STATES
▸Full report

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

Recall #:
88362
Lot/product code:
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Recalling firm:
Roche Diabetes Care, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 28, 2021

Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

ALL 50 STATES
▸Full report

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

Recall #:
88362
Lot/product code:
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Recalling firm:
Roche Diabetes Care, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2021

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

ALL 50 STATES
▸Full report

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

Recall #:
90603
Lot/product code:
Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712
Recalling firm:
Mizuho OSI
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 29, 2021

Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59

Defective container: possibility for lack of seal integrity.

ALL 50 STATES
▸Full report

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

Recall #:
D-0769-2021
Lot/product code:
Lot #: 14892, Exp 1/2022
Recalling firm:
Teligent Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2021

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

Failed Stability Specifications; not meeting quality requirements for shear.

ALL 50 STATES
▸Full report

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

Recall #:
D-0724-2021
Lot/product code:
Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022
Recalling firm:
Noven Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2021

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

Failed Stability Specifications; not meeting quality requirements for shear.

ALL 50 STATES
▸Full report

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

Recall #:
D-0725-2021
Lot/product code:
Lots: 88540 Exp. 03/2022; 89118 Exp. 05/2022; 89244 Exp. 07/2022; 89244 (sample lot) Exp. 07/2022
Recalling firm:
Noven Pharmaceuticals Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

ALL 50 STATES
▸Full report

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

Recall #:
88521
Lot/product code:
Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots:  20025450 20025451 20025452 20025531 20025532 20025533 20025534 20026527 20026529 20026532 20026533 20026534 20065580 20065582 20065581 20075239 20075240 20075241 20075242 20075618 20075619 20075447 20075448 20075449 20075450 20075451 20075452 20075453 20075790 20075791 20075924 20075792 20085362 20085363 20085364 20085365 20085421 20085422 20085522 20085523 20095302 20095303 20095310 20095533 20095534 20095311 20095312 20116500 20116501 21016470 21016471 21016593 20035697 20066252 20066399 20076260 20095373 20095887 20105859 20105860 20105861 20106710 21019903 21019904 21019905
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

ALL 50 STATES
▸Full report

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

Recall #:
88521
Lot/product code:
Model: 88000057 GTIN/UDI Codes: 06971576832026 / 01 06971576832026 240 88000057 21 200017 06971576832026 / 01 06971576832026 240 88000057 21 200023 06971576832026 / 01 06971576832026 240 88000057 21 200024 06971576832026 / 01 06971576832026 240 88000057 21 200036 06971576832026 / 01 06971576832026 240 88000057 21 200045 06971576832026 / 01 06971576832026 240 88000057 21 200047 06971576832057 / 01 06971576832057 240 88000057 21 230002 06971576832057 / 01 06971576832057 240 88000057 21 230003 06971576832057 / 01 06971576832057 240 88000057 21 230004 06971576832057 / 01 06971576832057 240 88000057 21 200059 06971576832057 / 01 06971576832057 240 88000057 21 230005 06971576832057 / 01 06971576832057 240 88000057 21 230006 06971576832057 / 01 06971576832057 240 88000057 21 230007 06971576832057 / 01 06971576832057 240 88000057 21 230008 06971576832057 / 01 06971576832057 240 88000057 21 230009 06971576832057 / 01 06971576832057 240 88000057 21 230010 06971576832057 / 01 06971576832057 240 88000057 21 230011 06971576832057 / 01 06971576832057 240 88000057 21 230012 06971576832057 / 01 06971576832057 240 88000057 21 230013 06971576832057 / 01 06971576832057 240 88000057 21 230014 06971576832057 / 01 06971576832057 240 88000057 21 230015 06971576832057 / 01 06971576832057 240 88000057 21 230016 06971576832057 / 01 06971576832057 240 88000057 21 230017 Serial Numbers: 200017; 200023; 200024; 200036; 200045; 200047; 230002; 230003; 230004; 200059; 230005; 230006; 230007; 230008; 230009; 230010; 230011; 230012; 230013; 230014; 230015; 230016; 230017;
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots:  20026597 20026598 20096477 20106218 20115237 20126022 20126023
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & SmartSite EXT SET, REF: 42407E-05

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots:  20025968 20026013 20035834 20035835 20026132 20026133 20085151
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots:  20077170 20077171 20077319 20077320
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)