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Recalls affecting Puerto Rico

Data last updated: September 10, 2026 at 1:16 PM UTC

16,258 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

▸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. 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)

▸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

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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.

▸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

Martina — Mangoes

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 December 10, 2020

Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

ALL 50 STATES
▸Full report

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

Recall #:
87023
Lot/product code:
Serial Numbers: 64GY51017, 64GY51020, 64GY51022, 64GZ51028, 64GZ51030, 64GZ51029, 64GY51021
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2020

VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

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▸Full report

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

Recall #:
87028
Lot/product code:
INITIAL Communication: 11 December 2020, (Communication Ref. # CL2020-302) Coatings 0230, 0231, 0233, 0235, 0239 (all lot numbers) Extended Recalls: Recall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication Reference, CL2021-182) 18 June 2021 Recall Extension #2 for VITROS CKMB Slides, Coating 0246 (Communication Reference, CL2021-214) 18 August 2021 Recall Extension #3 for VITROS CKMB Slides, Coating 0248 (Communication Reference, CL2021-274) , 1 November 2021 Recall Extension #4 for VITROS CKMB Slides, Coating 0261 (Communication Reference, CL2023-244) , 27 October 2023 UDI: (1) (10758750004294) (2) (10758750004201
Recalling firm:
Ortho Clinical Diagnostics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 14, 2020

VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200mm OUS VENEL16080 Venovo 10F 16/80/1200mm OUS VENEL16100 Venovo 10F 16/100/1200mm OUS VENEL16120 Venovo 10F 16/120/1200mm OUS VENEL16140 Venovo 10F 16/140/1200mm OUS VENEL16160 Venovo 10F 16/160/1200mm OUS VENEL18040 Venovo 10F 18/40/1200mm OUS VENEL18060 Venovo 10F 18/60/1200mm OUS VENEL18080 Venovo 10F 18/80/1200mm OUS VENEL18100 Venovo 10F 18/100/1200mm OUS VENEL18120 Venovo 10F 18/120/1200mm OUS VENEL18140 Venovo 10F 18/140/1200mm OUS VENEL18160 Venovo 10F 18/160/1200mm OUS VENEL20040 Venovo 10F 20/40/1200mm OUS VENEL20060 Venovo 10F 20/60/1200mm OUS VENEL20080 Venovo 10F 20/80/1200mm OUS VENEL20100 Venovo 10F 20/100/1200mm OUS VENEL20120 Venovo 10F 20/120/1200mm OUS VENEL20140 Venovo 10F 20/140/1200mm OUS VENEL20160 Venovo 10F 20/160/1200mm OUS VENEM16040 Venovo 10F 16/40/800mm OUS VENEM16060 Venovo 10F 16/60/800mm OUS VENEM16080 Venovo 10F 16/80/800mm OUS VENEM16100 Venovo 10F 16/100/800mm OUS VENEM16120 Venovo 10F 16/120/800mm OUS VENEM16140 Venovo 10F 16/140/800mm OUS VENEM16160 Venovo 10F 16/160/800mm OUS VENEM18040 Venovo 10F 18/40/800mm OUS VENEM18060 Venovo 10F 18/60/800mm OUS VENEM18080 Venovo 10F 18/80/800mm OUS VENEM18100 Venovo 10F 18/100/800mm OUS VENEM18120 Venovo 10F 18/120/800mm OUS VENEM18140 Venovo 10F 18/140/800mm OUS VENEM18160 Venovo 10F 18/160/800mm OUS VENEM20040 Venovo 10F 20/40/800mm OUS VENEM20060 Venovo 10F 20/60/800mm OUS VENEM20080 Venovo 10F 20/80/800mm OUS VENEM20100 Venovo 10F 20/100/800mm OUS VENEM20120 Venovo 10F 20/120/800mm OUS VENEM20140 Venovo 10F 20/140/800mm OUS VENEM20160 Venovo 10F 20/160/800mm OUS VENUL16040 Venovo 10F 16/40/1200mm US VENUL16060 Venovo 10F 16/60/1200mm US VENUL16080 Venovo 10F 16/80/1200mm US VENUL16100 Venovo 10F 16/100/1200mm US VENUL16120 Venovo 10F 16/120/1200mm US VENUL16140 Venovo 10F 16/140/1200mm US VENUL16160 Venovo 10F 16/160/1200mm US VENUL18040 Venovo 10F 18/40/1200mm US VENUL18060 Venovo 10F 18/60/1200mm US VENUL18080 Venovo 10F 18/80/1200mm US VENUL18100 Venovo 10F 18/100/1200mm US VENUL18120 Venovo 10F 18/120/1200mm US VENUL18140 Venovo 10F 18/140/1200mm US VENUL18160 Venovo 10F 18/160/1200mm US VENUL20040 Venovo 10F 20/40/1200mm US VENUL20060 Venovo 10F 20/60/1200mm US VENUL20080 Venovo 10F 20/80/1200mm US VENUL20100 Venovo 10F 20/100/1200mm US VENUL20120 Venovo 10F 20/120/1200mm US VENUL20140 Venovo 10F 20/140/1200mm US VENUL20160 Venovo 10F 20/160/1200mm US VENUM16040 Venovo 10F 16/40/800mm US VENUM16060 Venovo 10F 16/60/800mm US VENUM16080 Venovo 10F 16/80/800mm US VENUM16100 Venovo 10F 16/100/800mm US VENUM16120 Venovo 10F 16/120/800mm US VENUM16140 Venovo 10F 16/140/800mm US VENUM16160 Venovo 10F 16/160/800mm US VENUM18040 Venovo 10F 18/40/800mm US VENUM18060 Venovo 10F 18/60/800mm US VENUM18080 Venovo 10F 18/80/800mm US VENUM18100 Venovo 10F 18/100/800mm US VENUM18120 Venovo 10F 18/120/800mm US VENUM18140 Venovo 10F 18/140/800mm US VENUM18160 Venovo 10F 18/160/800mm US VENUM20040 Venovo 10F 20/40/800mm US VENUM20060 Venovo 10F 20/60/800mm US VENUM20080 Venovo 10F 20/80/800mm US VENUM20100 Venovo 10F 20/100/800mm US VENUM20120 Venovo 10F 20/120/800mm US VENUM20140 Venovo 10F 20/140/800mm US VENUM20160 Venovo 10F 20/160/800mm US

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

ALL 50 STATES
▸Full report

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

Recall #:
87208
Lot/product code:
Product Code/GTIN: VENEL16040 /00801741102431; VENEL16060 /00801741102448; VENEL16080 /00801741102455; VENEL16100 /00801741102462; VENEL16120 /00801741102479; VENEL16140 /00801741102486; VENEL16160 /00801741102493; VENEL18040 /00801741102578; VENEL18060 /00801741102585; VENEL18080 /00801741102592; VENEL18100 /00801741102608; VENEL18120 /00801741102967; VENEL18140 /00801741102974; VENEL18160 /00801741102981; VENEL20040 /00801741103063; VENEL20060 /00801741103070; VENEL20080 /00801741103087; VENEL20100 /00801741103094; VENEL20120 /00801741103100; VENEL20140 /00801741103117; VENEL20160 /00801741103124; VENEM16040 /00801741102363; VENEM16060 /00801741102370; VENEM16080 /00801741102387; VENEM16100 /00801741102394; VENEM16120 /00801741102400; VENEM16140 /00801741102417; VENEM16160 /00801741102424; VENEM18040 /00801741102509; VENEM18060 /00801741102516; VENEM18080 /00801741102523; VENEM18100 /00801741102530; VENEM18120 /00801741102547; VENEM18140 /00801741102554; VENEM18160 /00801741102561; VENEM20040 /00801741102998; VENEM20060 /00801741103001; VENEM20080 /00801741103018; VENEM20100 /00801741103025; VENEM20120 /00801741103032; VENEM20140 /00801741103049; VENEM20160 /00801741103056; VENUL16040 /00801741103629; VENUL16060 /00801741103636; VENUL16080 /00801741103643; VENUL16100 /00801741103650; VENUL16120 /00801741103667; VENUL16140 /00801741103674; VENUL16160 /00801741103681; VENUL18040 /00801741103766; VENUL18060 /00801741103773; VENUL18080 /00801741103780; VENUL18100 /00801741103797; VENUL18120 /00801741103803; VENUL18140 /00801741103810; VENUL18160 /00801741103827; VENUL20040 /00801741103902; VENUL20060 /00801741103919; VENUL20080 /00801741103926; VENUL20100 /00801741103933; VENUL20120 /00801741103940; VENUL20140 /00801741103957; VENUL20160 /00801741103964; VENUM16040 /00801741103551; VENUM16060 /00801741103568; VENUM16080 /00801741103575; VENUM16100 /00801741103582; VENUM16120 /00801741103599; VENUM16140 /00801741103605; VENUM16160 /00801741103612; VENUM18040 /00801741103698; VENUM18060 /00801741103704; VENUM18080 /00801741103711; VENUM18100 /00801741103728; VENUM18120 /00801741103735; VENUM18140 /00801741103742; VENUM18160 /00801741103759; VENUM20040 /00801741103834; VENUM20060 /00801741103841; VENUM20080 /00801741103858; VENUM20100 /00801741103865; VENUM20120 /00801741103872; VENUM20140 /00801741103889; VENUM20160 /00801741103896;  U.S. Devices Serial Numbers: ANEQ5007; ANEQ5008; ANEQ5009; ANEQ5010; ANEQ5011; ANEQ5012; ANEQ5013; ANEQ5014; ANEQ5015; ANEQ5016; ANEQ5017; ANEQ5018; ANEQ5019; ANEQ5020; ANEQ5021; ANEQ5022; ANER0482; ANER0483; ANER0484; ANER0485; ANER0486; ANER0487; ANER0488; ANER0489; ANER0494; ANER0495; ANER0496; ANER0497; ANER0498; ANER0499; ANER0500; ANER0501; ANER0502; ANER0503; ANER0504; ANER0511; ANER0512; ANER0513; ANER0514; ANER0530; ANER0531; ANER1498; ANER1499; ANER1500; ANER1501; ANER1504; ANER1505; ANER1506; ANER1531; ANER1532; ANER2801; ANER2802; ANER2803; ANER2804; ANER2805; ANER2806; ANER2807; ANER2808; ANER2809; ANER2810; ANER2811; ANER2820; ANER2821; ANER2822; ANER2823; ANER2824; ANER2825; ANER2826; ANER2827; ANER2828; ANER2829; ANER2830; ANER2831; ANER2832; ANER2833; ANER2834; ANER2835; ANER2836; ANER2839; ANER2840; ANER2842; ANER2843; ANER2844; ANER2846; ANER2847; ANER2848; ANER2849; ANER2850; ANER2856; ANER2857; ANER4199; ANER4200; ANER4201; ANER4203;; ANER4204; ANER4206; ANER4207; ANER4208; ANER4209; ANER4212; ANER4214; ANER4215; ANER4218; ANER4220; ANER4222; ANER4223; ANER4224; ANER4226; ANER4227; ANER4229; ANER4230; ANER4231; ANER4233; ANER4234; ANER4235; ANER4237; ANER4240; ANER4241; ANER4242; ANER4243; ANER5123; ANER5124; ANER5125; ANER5129; ANER5130; ANER5131; ANER5132; ANER5133; ANER5139; ANER5140; ANER5144; ANER5145; ANER5146; ANER5147; ANER5148; ANER5155; ANER5156; ANER5157; ANER5158; ANER5162; ANER5163; ANER5164; ANER5171; ANER5172; ANER5173; ANER5174; ANER5179; ANER5180; ANER5181; ANES1051; ANES1052; ANES1053; ANES1054; ANES1055; ANES1056; ANES1057; ANES1058; ANES1059; ANES2227; ANES2228; ANES2229; ANES2230; ANES2231; ANES2232; ANES2238; ANES3025; ANES3026; ANES3027; ANES3028; ANES3029; ANES3030; ANES3031; ANES3032; ANES3033; ANES3034; ANES3035; ANES3036; ANES3037; ANES3038; ANES3041; ANES3042; ANES3043; ANES3044; ANES3046; ANES3047; ANES3048; ANES3049; ANES3053; ANES3054; ANES3055; ANES3056; ANES3059; ANES3060; ANES3065; ANES3066; ANES3068; ANES4105; ANES4106; ANES4107; ANES4108; ANES4109; ANES4110; ANES4120; ANES4121; ANES4122; ANES4123; ANES4124; ANES4125; ANES4126; ANES4127; ANES4128; ANET0562; ANET0563; ANET0564; ANET0565; ANET0575; ANET0576; ANET0577; ANET0578; ANET0579; ANET0580; ANET0581; ANET0582; ANET0583; ANET1080; ANET1081; ANET1082; ANET1083; ANET1084; ANET1471; ANET1472; ANET1473; ANET1474; ANET1475; ANET1476; ANET1477; ANET1478; ANET1479; ANET1480; ANET1481; ANET1482; ANET1483; ANET1484; ANET1489; ANET1491; ANET1492; ANET1493; ANET1494; ANET1495; ANET1496; ANET1497; ANET1499; ANET1500; ANET1501; ANET1506; ANET1507; ANET2539; ANET2545; ANET2546; ANET2547… (truncated, 87873 characters total — see the official FDA record for the full value)
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 14, 2020

VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS; VENEL14080 /Venovo 9F 14/80/1200mm OUS; VENEL14100 /Venovo 9F 14/100/1200mm OUS; VENEL14120 /Venovo 9F 14/120/1200mm OUS; VENEL14140 /Venovo 9F 14/140/1200mm OUS; VENEL14160 /Venovo 9F 14/160/1200mm OUS; VENEM14040 /Venovo 9F 14/40/800mm OUS; VENEM14060 /Venovo 9F 14/60/800mm OUS; VENEM14080 /Venovo 9F 14/80/800mm OUS; VENEM14100 /Venovo 9F 14/100/800mm OUS; VENEM14120 /Venovo 9F 14/120/800mm OUS; VENEM14140 /Venovo 9F14/140/800mm OUS; VENEM14160 /Venovo 9F 14/160/800mm OUS; VENUL14040 /Venovo 9F 14/40/1200mm US; VENUL14060 /Venovo 9F 14/60/1200mm US; VENUL14080 /Venovo 9F 14/80/1200mm US; VENUL14100 /Venovo 9F 14/100/1200mm US; VENUL14120 /Venovo 9F 14/120/1200mm US; VENUL14140 /Venovo 9F 14/140/1200mm US; VENUL14160 /Venovo 9F 14/160/1200mm US; VENUM14040 /Venovo 9F 14/40/800mm US; VENUM14060 /Venovo 9F 14/60/800mm US; VENUM14080 /Venovo 9F 14/80/800mm US; VENUM14100 /Venovo 9F 14/100/800mm US; VENUM14120 /Venovo 9F 14/120/800mm US; VENUM14140 /Venovo 9F 14/140/800mm US; VENUM14160 /Venovo 9F 14/160/800mm US;

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

ALL 50 STATES
▸Full report

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

Recall #:
87208
Lot/product code:
Product Code/GTIN: VENEL14040 /00801741102295; VENEL14060 /00801741102301; VENEL14080 /00801741102318; VENEL14100 /00801741102325; VENEL14120 /00801741102332; VENEL14140 /00801741102349; VENEL14160 /00801741102356; VENEM14040 /00801741102226; VENEM14060 /00801741102233; VENEM14080 /00801741102240; VENEM14100 /00801741102257; VENEM14120 /00801741102264; VENEM14140 /00801741102271; VENEM14160 /00801741102288; VENUL14040 /00801741103483; VENUL14060 /00801741103490; VENUL14080 /00801741103506; VENUL14100 /00801741103513; VENUL14120 /00801741103520; VENUL14140 /00801741103537; VENUL14160 /00801741103544; VENUM14040 /00801741103414; VENUM14060 /00801741103421; VENUM14080 /00801741103438; VENUM14100 /00801741103445; VENUM14120 /00801741103452; VENUM14140 /00801741103469; VENUM14160 /00801741103476;  U.S. Device Serial Numbers: ANEP2484; ANEP2485; ANEP2487; ANEP3962; ANEP3964; ANEP3966; ANEP3968; ANEP3972; ANEP3973; ANEP3979; ANEP3982; ANEP3986; ANEP5357; ANEP5362; ANEP5363; ANEP5364; ANEP5367; ANEP5368; ANEP5370; ANEP5373; ANEP5375; ANEP5378; ANEQ0213; ANEQ0216; ANEQ0217; ANEQ0219; ANEQ0220; ANEQ0221; ANEQ1381; ANEQ1382; ANEQ1383; ANEQ1384; ANEQ1402; ANEQ1403; ANEQ1404; ANEQ1405; ANEQ1406; ANEQ1407; ANEQ1408; ANEQ1409; ANEQ1410; ANEQ1411; ANEQ2758; ANEQ2759; ANEQ2777; ANEQ2778; ANEQ3075; ANEQ3076; ANEQ4080; ANEQ4081; ANEQ4082; ANEQ4083; ANEQ4092; ANEQ4093; ANEQ4094; ANEQ4106; ANEQ4387; ANEQ4747; ANEQ4748; ANEQ4749; ANEQ4752; ANEQ4981; ANEQ4982; ANEQ4983; ANEQ4984; ANEQ4985; ANEQ4998; ANEQ4999; ANEQ5000; ANEQ5001; ANEQ5002; ANER0479; ANER0480; ANER0481; ANER0492; ANER0493; ANER0533; ANER0534; ANER1497; ANER1503; ANER2390; ANER2391; ANER2392; ANER2393; ANER2394; ANER2395; ANER2798; ANER2799; ANER2800; ANER2817; ANER2818; ANER2819; ANER2837; ANER2845; ANER2851; ANER2852; ANER2853; ANER2854; ANER4202; ANER4205; ANER4210; ANER4211; ANER4213; ANER4216; ANER4219; ANER4221; ANER4225; ANER4232; ANER5121; ANER5122; ANER5128; ANER5137; ANER5138; ANER5143; ANER5154; ANER5161; ANER5170; ANER5176; ANER5177; ANER5178; ANES1034; ANES1050; ANES2225; ANES2226; ANES2237; ANES3023; ANES3039; ANES3040; ANES3051; ANES3052; ANES3057; ANES3058; ANES3061; ANES3062; ANES3063; ANES3064; ANES3130; ANES4104; ANES4119; ANET0569; ANET0570; ANET0571; ANET0572; ANET0573; ANET0574; ANET1485; ANET1486; ANET1487; ANET1488; ANET1498; ANET1502; ANET1503; ANET1504; ANET1505; ANET2538; ANET2542; ANET2543; ANET2544; ANET2560; ANET2568; ANET2569; ANET2570; ANET2571; ANET2572; ANET3801; ANET3802; ANET3803; ANET3819; ANET3820; ANET3821; ANET3822; ANET3823; ANET3842; ANET3879; ANET3880; ANEU0744; ANEU0749; ANEU0750; ANEU0751; ANEU0752; ANEU0753; ANEU0754; ANEU0772; ANEU1595; ANEU1607; ANEU1608; ANEU1609; ANEU1610; ANEU1627; ANEU2434; ANEU2435; ANEU2436; ANEU2443; ANEU2444; ANEU2445; ANEU2446; ANEU2447; ANEU2448; ANEU3279; ANEU3291; ANEU3292; ANEU3293; ANEU3294; ANEU4228; ANEU4233; ANEU4234; ANEU4241; ANEU4242; ANEU4247; ANEU4248; ANEU4249; ANEU4257; ANEV0589; ANEV0597; ANEV0600; ANEV0604; ANEV0615; ANEV1719; ANEV1720; ANEV1721; ANEV1722; ANEV1741; ANEV1742; ANEV1743; ANEV1744; ANEV1745; ANEV2618; ANEV3071; ANEV3072; ANEV3083; ANEV3084; ANEV3085; ANEV3497; ANEV4026; ANEV4027; ANEV4028; ANEV4029; ANEV4030; ANEV4047; ANEV4048; ANEV4049; ANEV4050; ANEV4051; ANEV4074; ANEW0555; ANEW0567; ANEW0568; ANEW0569; ANEW0570; ANEW0571; ANEW0572; ANEW0573; ANEW0574; ANEW0596; ANEW0597; ANEW1518; ANEW1586; ANEW2008; ANEW2009; ANEW2010; ANEW2011; ANEW2035; ANEW2036; ANEW2236; ANEW2237; ANEW2530; ANEW2774; ANEW3382; ANEW3383; ANEW3384; ANEW3385; ANEW3398; ANEW3399; ANEW3400; ANEW3423; ANEW3425; ANEW3426; ANEX0698; ANEX0714; ANEX0718; ANEX0725; ANEX0756; ANEX1728; ANEX1729; ANEX1731; ANEX1732; ANEX1733; ANEX1735; ANEX1738; ANEX1741; ANEX1745; ANEX1749; ANEX3102; ANEX3103; ANEX3106; ANEX3107; ANEX3108; ANEX3109; ANEX3110; ANEX3111; ANEX3114; ANEX3128; ANEX3133; ANEX3134; ANEX3140; ANEX4723; ANEX4724; ANEX4727; ANEX4728; ANEX4729; ANEX4739; ANEX4741; ANEX4749; ANEX4754; ANEX4757; ANEX4771; ANEX4774; ANEX4776; ANEX6029; ANEX6030; ANEX6031; ANEX6040; ANEX6041; ANEX6043; ANEX6044; ANEX6047; ANEX6050; ANEX6051; ANEX6058; ANEX6069; ANEY1238; ANEY1239; ANEY1245; ANEY1252; ANEY1253; ANEY1260; ANEY1261; ANEY1270; ANEY1271; ANEY1281; ANEY2057; ANEY2058; ANEY2059; ANEY2060; ANEY2061; ANEY2062; ANEY2063; ANEY3215; ANEY3216; ANEY3219; ANEY3220; ANEY3221; ANEY3222; ANEY3223; ANEY3224; ANEY3227; ANEY3228; ANEY3229; ANEY3230; ANEY3233; ANEY3234; ANEY3259; ANEY4238; ANEY4330; ANEY4331; ANEY4332; ANEY4333; ANEY4334; ANEY4335; ANEY4336; ANEY4337; ANEY4338; ANEY4339; ANEY4340; ANEY4341; ANEY4342; ANEY4343; ANEY4348; ANEY4559; ANEY4561; ANEZ0934; ANEZ0935; ANEZ0936; ANEZ0938; ANEZ0939; ANEZ0940; ANEZ0941; ANEZ0942; ANEZ0943; ANEZ0946; ANEZ0947; ANEZ0948; ANEZ0949; ANEZ0950; ANEZ0951; ANEZ0952; ANEZ0953; ANEZ1475; ANEZ2108; ANEZ2114; ANEZ2115; ANEZ2116; ANEZ2117; ANEZ2125; ANEZ2126; ANEZ2127; ANEZ2128; ANEZ2129; ANEZ2130; ANEZ2141; ANEZ2142; ANEZ2143; ANEZ2144; ANEZ2145; ANEZ2146; ANEZ3440; ANEZ3441… (truncated, 45631 characters total — see the official FDA record for the full value)
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 14, 2020

VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/60/1200mm OUS; VENEL10080 /Venovo 8F 10/80/1200mm OUS; VENEL10100 /Venovo 8F 10/100/1200mm OUS; VENEL10120 /Venovo 8F 10/120/1200mm OUS; VENEL10140 /Venovo 8F 10/140/1200mm OUS; VENEL10160 /Venovo 8F10/160/1200mm OUS; VENEL12040 /Venovo 8F 12/40/1200mm OUS; VENEL12060 /Venovo 8F 12/60/1200mm OUS; VENEL12080 /Venovo 8F 12/80/1200mm OUS; VENEL12100 /Venovo 8F 12/100/1200mm OUS; VENEL12120 /Venovo 8F 12/120/1200mm OUS; VENEL12140 /Venovo 8F 12/140/1200mm OUS; VENEL12160 /Venovo 8F 12/160/1200mm OUS; VENEM10040 /Venovo 8F 10/40/800mm OUS; VENEM10060 /Venovo 8F 10/60/800mm OUS; VENEM10080 /Venovo 8F 10/80/800mm OUS; VENEM10100 /Venovo 8F 10/100/800mm OUS; VENEM10120 /Venovo 8F 10/120/800mm OUS; VENEM10140 /Venovo 8F 10/140/800mm OUS; VENEM10160 /Venovo 8F 10/160/800mm OUS; VENEM12040 /Venovo 8F 12/40/800mm OUS; VENEM12060 /Venovo 8F 12/60/800mm OUS; VENEM12080 /Venovo 8F 12/80/800mm OUS; VENEM12100 /Venovo 8F 12/100/800mm OUS; VENEM12120 /Venovo 8F 12/120/800mm OUS; VENEM12140 /Venovo 8F 12/140/800mm OUS; VENEM12160 /Venovo 8F 12/160/800mm OUS; VENUL10040 /Venovo 8F 10/40/1200mm US; VENUL10060 /Venovo 8F 10/60/1200mm US; VENUL10080 /Venovo 8F 10/80/1200mm US; VENUL10100 /Venovo 8F 10/100/1200mm US; VENUL10120 /Venovo 8F 10/120/1200mm US; VENUL10140 /Venovo 8F 10/140/1200mm US; VENUL10160 /Venovo 8F 10/160/1200mm US; VENUL12040 /Venovo 8F 12/40/1200mm US; VENUL12060 /Venovo 8F 12/60/1200mm US; VENUL12080 /Venovo 8F 12/80/1200mm US; VENUL12100 /Venovo 8F 12/100/1200mm US; VENUL12120 /Venovo 8F 12/120/1200mm US; VENUL12140 /Venovo 8F 12/140/1200mm US; VENUL12160 /Venovo 8F 12/160/1200mm US; VENUM10040 /Venovo 8F 10/40/800mm US; VENUM10060 /Venovo 8F 10/60/800mm US; VENUM10080 /Venovo 8F 10/80/800mm US; VENUM10100 /Venovo 8F 10/100/800mm US; VENUM10120 /Venovo 8F 10/120/800mm US; VENUM10140 /Venovo 8F 10/140/800mm US; VENUM10160 /Venovo 8F 10/160/800mm US; VENUM12040 /Venovo 8F 12/40/800mm US; VENUM12060 /Venovo 8F 12/60/800mm US; VENUM12080 /Venovo 8F 12/80/800mm US; VENUM12100 /Venovo 8F 12/100/800mm US; VENUM12120 /Venovo 8F 12/120/800mm US; VENUM12140 /Venovo 8F 12/140/800mm US; VENUM12160 /Venovo 8F 12/160/800mm US;

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

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

Recall #:
87208
Lot/product code:
Product Code/GTIN: VENEL10040 /00801741102004; VENEL10060 /00801741104664; VENEL10080 /00801741104671; VENEL10100 /00801741102035; VENEL10120 /00801741102042; VENEL10140 /00801741102059; VENEL10160 /00801741102066; VENEL12040 /00801741102141; VENEL12060 /00801741102158; VENEL12080 /00801741102172; VENEL12100 /00801741102189; VENEL12120 /00801741102196; VENEL12140 /00801741102202; VENEL12160 /00801741102219; VENEM10040 /00801741101939; VENEM10060 /00801741101946; VENEM10080 /00801741101953; VENEM10100 /00801741101960; VENEM10120 /00801741101977; VENEM10140 /00801741101984; VENEM10160 /00801741101991; VENEM12040 /00801741102073; VENEM12060 /00801741102080; VENEM12080 /00801741102097; VENEM12100 /00801741102103; VENEM12120 /00801741102110; VENEM12140 /00801741102127; VENEM12160 /00801741102134; VENUL10040 /00801741103209; VENUL10060 /00801741103216; VENUL10080 /00801741103223; VENUL10100 /00801741103230; VENUL10120 /00801741103247; VENUL10140 /00801741103254; VENUL10160 /00801741103261; VENUL12040 /00801741103346; VENUL12060 /00801741103353; VENUL12080 /00801741103360; VENUL12100 /00801741103377; VENUL12120 /00801741103384; VENUL12140 /00801741103391; VENUL12160 /00801741103407; VENUM10040 /00801741103131; VENUM10060 /00801741103148; VENUM10080 /00801741103155; VENUM10100 /00801741103162; VENUM10120 /00801741103179; VENUM10140 /00801741103186; VENUM10160 /00801741103193; VENUM12040 /00801741103278; VENUM12060 /00801741103285; VENUM12080 /00801741103292; VENUM12100 /00801741103308; VENUM12120 /00801741103315; VENUM12140 /00801741103322; VENUM12160 /00801741103339;  U.S. Device; Serial Numbers: ANEQ4079; ANEQ4090; ANEQ4091; ANEQ4101; ANEQ4104; ANEQ4105; ANEQ4109; ANEQ4978; ANEQ4979; ANEQ4980; ANEQ4996; ANEQ4997; ANEQ5023; ANER0477; ANER0478; ANER0490; ANER0491; ANER0510; ANER0515; ANER0532; ANER1502; ANER1528; ANER1529; ANER1530; ANER1533; ANER2795; ANER2796; ANER2797; ANER2812; ANER2813; ANER2814; ANER2815; ANER2816; ANER2838; ANER2841; ANER2855; ANER4217; ANER4228; ANER4236; ANER4238; ANER4239; ANER5126; ANER5127; ANER5136; ANER5141; ANER5142; ANER5153; ANER5159; ANER5160; ANER5169; ANER5175; ANES2223; ANES2224; ANES2233; ANES2234; ANES2235; ANES2236; ANES3045; ANES3050; ANES3067; ANES4102; ANES4103; ANES4111; ANES4112; ANES4113; ANES4114; ANES4115; ANES4116; ANES4117; ANES4118; ANET0561; ANET0566; ANET0567; ANET0568; ANET1490; ANET1508; ANET1509; ANET2533; ANET2534; ANET2535; ANET2536; ANET2537; ANET2540; ANET2541; ANET3797; ANET3798; ANET3799; ANET3800; ANET3814; ANET3815; ANET3816; ANET3817; ANET3818; ANET3877; ANET3878; ANEU0748; ANEU1594; ANEU1601; ANEU1602; ANEU1603; ANEU1604; ANEU1605; ANEU1606; ANEU2442; ANEU3275; ANEU3276; ANEU3277; ANEU3278; ANEU3284; ANEU3285; ANEU3286; ANEU3287; ANEU3288; ANEU3289; ANEU3290; ANEU3306; ANEU4231; ANEU4232; ANEU4238; ANEU4239; ANEU4240; ANEU4246; ANEU4253; ANEU4256; ANEU4260; ANEU4261; ANEU4264; ANEU4265; ANEV0586; ANEV0587; ANEV0591; ANEV0594; ANEV0598; ANEV0599; ANEV0603; ANEV0606; ANEV0611; ANEV0614; ANEV1714; ANEV1715; ANEV1716; ANEV1717; ANEV1718; ANEV1737; ANEV1738; ANEV1739; ANEV1740; ANEV3078; ANEV3079; ANEV3080; ANEV3081; ANEV3082; ANEV3494; ANEV4019; ANEV4020; ANEV4021; ANEV4022; ANEV4023; ANEV4024; ANEV4025; ANEV4043; ANEV4044; ANEV4045; ANEV4046; ANEV4071; ANEV4076; ANEW0553; ANEW0554; ANEW0560; ANEW0561; ANEW0562; ANEW0563; ANEW0564; ANEW0565; ANEW0566; ANEW0599; ANEW0600; ANEW2005; ANEW2006; ANEW2007; ANEW2028; ANEW2029; ANEW2030; ANEW2031; ANEW2032; ANEW2033; ANEW2034; ANEW2239; ANEW2772; ANEW2773; ANEW3378; ANEW3379; ANEW3380; ANEW3381; ANEW3394; ANEW3395; ANEW3396; ANEW3397; ANEW3422; ANEW4229; ANEW4230; ANEW4231; ANEW4232; ANEW4233; ANEW4242; ANEW4243; ANEW4244; ANEW4245; ANEW4246; ANEW4247; ANEW4276; ANEW4280; ANEW4282; ANEW4291; ANEW4297; ANEW4298; ANEW4300; ANEX0704; ANEX0711; ANEX0713; ANEX0720; ANEX0729; ANEX0732; ANEX0735; ANEX0736; ANEX0739; ANEX0740; ANEX0741; ANEX0742; ANEX0743; ANEX0744; ANEX0745; ANEX1737; ANEX1743; ANEX1744; ANEX1746; ANEX1747; ANEX1750; ANEX1752; ANEX1753; ANEX1754; ANEX1755; ANEX3120; ANEX3121; ANEX3123; ANEX3131; ANEX3135; ANEX3136; ANEX3137; ANEX3144; ANEX3145; ANEX3147; ANEX3148; ANEX3149; ANEX3151; ANEX3153; ANEX3154; ANEX3156; ANEX4737; ANEX4740; ANEX4744; ANEX4745; ANEX4751; ANEX4753; ANEX4761; ANEX4762; ANEX4764; ANEX4773; ANEX4779; ANEX4780; ANEX4782; ANEX4783; ANEX4784; ANEX4785; ANEX4786; ANEX4787; ANEX4788; ANEX4789; ANEX6042; ANEX6046; ANEX6049; ANEX6056; ANEX6057; ANEX6065; ANEX6066; ANEX6068; ANEY1246; ANEY1247; ANEY1251; ANEY1257; ANEY1258; ANEY1259; ANEY1262; ANEY1263; ANEY1264; ANEY1265; ANEY1266; ANEY1267; ANEY1268; ANEY1269; ANEY1278; ANEY1279; ANEY1280; ANEY2049; ANEY2050; ANEY2051; ANEY2052; ANEY2053; ANEY2054; ANEY2055; ANEY2056; ANEY3241; ANEY3243; ANEY3245; ANEY3255; ANEY3256; ANEY3257; ANEY3258; ANEY3261; ANEY3537; ANEY3538; ANEY4346; ANEY4354; ANEY4355; ANEY4356; ANEY4357; ANEY4358; ANEY4562; ANEZ0957; ANEZ0958; ANEZ0959; ANEZ0967; ANEZ0972; ANEZ0973; ANEZ0974; ANEZ0980; ANEZ0996; ANEZ0997; ANE… (truncated, 36595 characters total — see the official FDA record for the full value)
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2020

REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction

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▸Full report

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

Recall #:
87069
Lot/product code:
Lot # 0219948893, 0220166870, 0220236215, 0220704352, 0220720015, 0220752505
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2020

REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction

ALL 50 STATES
▸Full report

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

Recall #:
87069
Lot/product code:
Lot # 0219927059, 0220149614, 0220393237, 0220601648,0220601649, 0220813029
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2020

REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction

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▸Full report

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

Recall #:
87069
Lot/product code:
Lot # 0219281777
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled December 17, 2020

ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by Ndal Laboratories, 449 Alvarado St., Monterey, CA 93940 (bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8. the Alvarado St. is for the bottle by putting "(bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8." (according to the label)

Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0269-2021
Lot/product code:
LOT # 2010045; Best Before 10 2023
Recalling firm:
NDAL Mfg Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 21, 2020

PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.

Medical device non-conformance to electrical safety standard (IEC 60601-1).

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

Recall #:
87011
Lot/product code:
Serial numbers 3. Serial numbers 320, 470, 507, 534, 621, 757, 770, 795, 892, 1165-1183, 1186- 1205, 1214-1293, 1295-1297, 1304-1330, 1333-1342, 1358 -1384, 1387-1389, 1391-1413, 1421-1430, 1434-1505, 1507- 1516.
Recalling firm:
Nihon Kohden America Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

ALL 50 STATES
▸Full report

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

Recall #:
88225
Lot/product code:
All lots sold prior to December 9, 2019.
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)

Device was distributed without a proper marketing authorization.

ALL 50 STATES
▸Full report

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)

Device was distributed without a proper marketing authorization.

ALL 50 STATES
▸Full report

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)

Device was distributed without a proper marketing authorization.

ALL 50 STATES
▸Full report

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)

Device was distributed without a proper marketing authorization.

ALL 50 STATES
▸Full report

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Deluxe At Home Artificial Insemination Kit (SKU 636391205832)

Device was distributed without a proper marketing authorization.

ALL 50 STATES
▸Full report

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Pro Series Fertility Device (SKU 644042788139)

Device was distributed without a proper marketing authorization.

ALL 50 STATES
▸Full report

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.

The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.

ALL 50 STATES
▸Full report

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

Recall #:
87176
Lot/product code:
Model Number - MS25510, MS25520, MS26372 Revisions 24 to 29
Recalling firm:
Draegar Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)

Device was distributed without a proper marketing authorization.

ALL 50 STATES
▸Full report

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Premium At Home Pro Series Insemination Kit (SKU 644042787927)

Device was distributed without a proper marketing authorization.

ALL 50 STATES
▸Full report

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)

Device was distributed without a proper marketing authorization.

ALL 50 STATES
▸Full report

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)

Device was distributed without a proper marketing authorization.

ALL 50 STATES
▸Full report

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

ALL 50 STATES
▸Full report

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

Recall #:
88225
Lot/product code:
All lots sold prior to December 9, 2019.
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

ALL 50 STATES
▸Full report

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

Recall #:
88225
Lot/product code:
All lots sold prior to December 9, 2019.
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

ALL 50 STATES
▸Full report

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

Recall #:
88225
Lot/product code:
All lots sold prior to December 9, 2019.
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)