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Recalls affecting Iowa

Data last updated: September 8, 2026 at 1:13 PM UTC

16,604 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 Men — dietary 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/virusAnnounced 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

▸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/virusAnnounced September 3, 2026

Great Value — Organic 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)
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

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

▸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)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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)
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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2019

Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

ALL 50 STATES
▸Full report

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

Recall #:
82927
Lot/product code:
Lot Number: 907734
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2019

Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

ALL 50 STATES
▸Full report

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

Recall #:
82927
Lot/product code:
Lot Number: 905659, 905660, 906343
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2019

Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

ALL 50 STATES
▸Full report

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

Recall #:
82927
Lot/product code:
Lot Number: 902110, 902111
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 3, 2019

Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.

Insulin dosing calculations were erroneously high.

ALL 50 STATES
▸Full report

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

Recall #:
82828
Lot/product code:
Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10
Recalling firm:
Monarch Medical Technologies
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 9, 2019

Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.

The titanium implant has the wrong article number laser marked on it.

ALL 50 STATES
▸Full report

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

Recall #:
82796
Lot/product code:
Model Number: 21206-10; Lot Code: 26/F42778
Recalling firm:
I.T.S. GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 15, 2019

InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).

There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).

ALL 50 STATES
▸Full report

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

Recall #:
82626
Lot/product code:
Model Numbers/UDI: a) TH90G01/00763000058005  b) TH90GFA/00763000187231 c) TH90G02/00763000192259, 00763000192266, 00763000192273,  00763000192280, 00763000192297, 00763000192303, 00763000192310 d) TH90G03/00763000192310  ALL LOT/SERIAL NUMBERS
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
lots N5A0871KX N7A0527KX N7E0441KX N8J0039KX N8J0527KX N8J0820KX
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
N6E0296UX N6J1034UX N6J1035UX N6J1036UX N6L0007UX N6L0365UX N6L0721UX N6M0608UX N7A0414UX N7A0844UX N7B0401UX N7C0194X N7E0781X N7F0551X N7F1021X N7F1125X N7H0540X N7H1065X N7K0033X N7K0564X N7L0401X N7M0203X N7M0759X N8A0152X N8A0404X N8A0977X N8B0943X N8C0165X N8C0854X N8D0508X N8D1062X N8E0561X N8E0932X N8E0989X N8E1006X N8E1009X N8E1028X N8J0178X N8M0424Y N8M0530Y N8M0531Y
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
N6E0295UX N6H0576UX N6J1092UX N6K0230UX N6K0938UX N6L0422URX N6L0777UX N6M0607UX N7A0415UX N7C0112X N7D1013X N7E1089X N7F0275X N7F1126X N7G0444X N7H0047X N7H1067X N7J0175X N7L0825X N8A0249X N8A0655X N8B0455X N8B0945X N8C0757X N8C1213X N8D0593X N8D0907X N8E0015X N8G0648X N8J0764X N8K0823KY N8K0840Y N8L0166Y N8L0436Y N8M0845Y N9A0204Y N9B0455Y
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
N6E0033UX N6H0768UX N6H0772UX N6K0521UX N6K0522UX N6K0667UX N6K0668UX N6L0687UX N6M0399UX N7A0018UX N7A0213UX N7A0401UX N7A0837UX N7B0787UX N7C0238X N7C0470X N7E0496X N7E1088X N7F0670X N7H0962X N7J0370X N8A0188X N8B0057X N8B0483X N8B0940X N8D0365X N8D0649X N8E0092X N8E0213X N8E0516X N8E1178X N8F0483X N8F0819X N8F0974X N8J0440X N8L0589Y N8M0529Y N9A0050Y N9A0427Y
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
N6B0080KX N6C0975KX
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
N6B0079KX N8A0029KX
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

EGIA45 CT AR MD THK REL, EGIA45CTAMT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
N8L0401KY
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
N4C1545KX N4C1718KX N4D0042KX N4D0366KX N4D0453KX N4D0589KX N4D0605KX N4D0688KX N4D0814KX N4D0897KX N4D1145KX N4E1383KX N4E1505KX N4F0006KX N4F0076KX N4F0114KX N4F0516KX N4F0695KX N4F0719KX N4F0853KX N4F0929KX N4F0981KX N4F1092KX N4F1159KX N4F1163KX N4F1331KX N4F1383KX N4F1450KX N4F1542KX N4H0432KX N4H0475KX N4H0503KX N4J1170KX N4K0212KX N4K0742KX N4K0757KX N4K0835KX N4K0870KX N4L0249KX N4L0315KX N4M0982KX N4M1062KX N5A0286KX N5A0345KX N5A0364KX N5A1461KX N5B0031KX N5B0700KX N5B0757KX N5B0794KX N5B0856KX N5C0465KX N5C0639KX N5C0668KX N5C0725KX N5C0758KRX N5C0914KX N5C0986KX N5D0862KX N5E0348KX N5E1158KX N5E1213KX N5E1245KX N5F0181KX N5F0260KX N5F0330KX N5F0348KX N5G0114KX N5G0154KX N5G0186KX N5G0660KX N5G0877KX N5G0983KX N5G1011KX N5G1122KX N5G1147KX N5G1248KX N5H0100KX N5H0226KX N5H0250KX N5H0481KX N5H0623KX N5H0676KX N5H0730KX N5H0762KX N5H0838KX N5H0949KX N5H0970KX N5H0993KX N5H1013KX N5H1082KX N5H1111KX N5H1158KX N5H1186KX N5H1216KX N5J0220KX N5J0266KX N5J0295KX N5J0321KX N5J0418KX N5J0492KX N5J0512KX N5J0532KX N5J0572KX N5J0658KX N5J0694KX N5J0775KX N5J0816KX N5J0966KX N5J1099KX N5J1130KX N5K0139KX N5K0208KX N5K0308KX N5K0374KX N5K0412KX N5K0429KX N5K0564KX N5K0595KX N5K0629KX N5K0665KX N5K0700KX N5K0732KX N5K0775KX N5K0848KX N5K0895KX N5K0941KX N5K0992KX N5K1054KX N5L0595KX N5L0673KRX N5L0746KX N5L0809KX N5M0088KX N5M0150KX N5M0459KX N5M0491KX N5M0536KX N5M0582KX N5M0632KX N5M0769KX N5M0827KX N6A0004KX N6A0034KX N6A0086KX N6A0124KX N6A0253KX N6A0255KX N6A0428KX N6A0520KX N6A0527KX N6B0028KX N6B0052KX N6B0081KX N6B0105KX N6B0135KX N6B0177KX N6B0219KX N6B0270KX N6B0323KX N6B0386KX N6B0405KX N6B0477KX N6B0504KX N6B0541KX N6B0624KX N6B0722KX N6B0746KX N6B0788KX N6B0852KX N6B0923KX N6C0355KX N6C0369KX N6C0370KX N6C0398KX N6C0509KX N6C0524KX N6C0562KX N6C0589KX N6C0598KX N6C0678KX N6C0701KX N6C0737KX N6C0753KX N6C0800KX N6C0841KX N6C0889KX N6C0913KX N6C0938KX N6C0972KX N6D0009KX N6D0051KX N6D0070KX N6D0091KX N6D0160KX N6D0180KX N6D0230KX N6D0283KX N6D0285KX N6D0334KX N6D0376KX N6D0536KX N6D0580KX N6D0607KX N6D0672KX N6D0715KX N6D0735KX N6D0757KX N6D0796KX N6D0830KX N6D0903KX N6D0924KX N6E0002KX N6E0068KX N6E0244KX N6E0287KX N6E0335KX N6E0462KX N6E0573KX N6E0600KX N6E0652KX N6E0691KX N6F0087KX N6F0165KX N6F0211KX N6F0232KX N6F0279KX N6F0307KX N6F0385KX N6F0397KX N6F0442KX N6F0474KX N6F0512KX N6F0541KX N6F0573KX N6F0611KX N6F0656KX N6F0659KX N6F0705KX N6F0935KX N6J0202KX N6J0314KX N6J0364KX N6K0742KX N6L0523KX N6L0527KX N6L0556KX N6L0634KX N6L0946KX N6M0329KX N6M0556KX N6M0698KX N6M0729KX N6M0737KX N7A0086KX N7A0131KX N7A0167KX N7A0208KX N7A0227KX N7A0941KX N7B0024KX N7B0123KX N7B0345KX N7B0591KX N7B0739KX N7C0275KX N7C0332KX N7C0371KX N7C0756KX N7C0799KX N7C0833KX N7C0959KX N7D0453KX N7D0592KX N7D0632KX N7D0690KX N7D0744KX N7D0908KX N7D0949KX N7E0043KX N7E0109KX N7E0148KX N7E0188KX N7E0223KX N7E0304KX N7E0605KX N7E0726KX N7E0806KX N7E0990KX N7F0061KX N7F0157KX N7F0173KX N7F0307KX N7F0370KX N7F0500KX N7F0589KX N7F0868KX N7F0903KX N7F0923KX N7F0961KX N7F0964KX N7G0062KX N7G0209KX N7G0246KX N7G0287KX N7G0661KX N7G0689KX N7G0723KX N7G0775KX N7H0102KX N7H0396KX N7H0422KX N7H0464KX N7H0493KX N7H0716KX N7H0762KX N7H0827KX N7H0867KX N7J0214KX N7J0254KX N7J0286KX N7J0371KX N7J0386KX N7J0420KX N7J0454KX N7J0748KX N7J0792KX N7J0845KX N7J0884KX N7K1094KX N7K1119KX N7L0635KX N7L0737KX N7L0738KX N7L0894KX N7L0957KX N7M0072KX N7M0322KX N7M0323KX N7M0785KX N7M0864KX N8A0098KX N8A0744KX N8A0818KX N8A0819KX N8A0882KX N8A0911KX N8A1044KX N8B0311KX N8B0372KX N8B0411KX N8B0458KX N8B0497KX N8B0553KX N8C0112KX N8C0638KX N8D0183KX N8D0226KX N8D0242KX N8D0314KX N8E0633KX N8E0676KX N8E0687KX N8E0814KX N8E1013KX N8E1060KX N8E1135KX N8E1175KX N8E1177KX N8F0098KX N8F0523KX N8F0581KX N8F0619KX N8F1045KX N8F1111KX N8G0035KX N8G0067KX N8G0122KX N8G0179KX N8G0202KX N8G0217KX N8G0244KX N8G0284KX N8G0351KX N8G0388KX N8G0440KX N8G0468KX N8G0489KX N8G0513KX N8G0550KX N8G0566KX N8G0624KX N8G0688KX N8G0697KX N8G0752KX N8G0780KX N8G0839KX N8G0879KX N8G0880KX N8G0936KX N8G0983KX N8G1025KX N8H0016KX N8H0089KX N8H0135KX N8H0159KX N8H0175KX N8H0220KX N8H0298KX N8H0332KX N8H0372KX N8H0406KX N8H0434KX N8H0474KX N8H0506KX N8H0574KX N8H0600KX N8H0606KX N8H0613KX N8H0652KX N8H0653KX N8H0750KX N8H0776KX N8H0800KX N8H0815KX N8H0868KX N8H0894KX N8H0940KX N8H0969KX N8J0005KX N8J0030KX N8J0060KX N8J0102KX N8J0188KX N8J0221KX N8J0260KX N8J0301KX N8J0313KX N8J0319KX N8J0414KX N8J0443KX N8J0494KX N8J0523KX N8J0534KX N8J0564KX N8J0617KX N8J0686KX N8J0723KX N8J0762KX N8J0787KX N8J0810KX N8J0852KX N8J0882KX N8J0952KX N8J0990KX N8J1019KX N8J1064KX N8J1070KX N8K0016KX N8K0081KX N8K0110KX N8K0136KX N8K0180KX N8K0212KX N8K0231KX N8K0254KX N8K0319KX N8K0361KX N8K0393KX N8K0421KX N8K0437KX N8K0452KX N8K0492KX N8K0531KX N8K0584KX N8K0632KX N8K0697KY N8K0709KY N8K0762KY N8K0800KY N8K0842KY N8K0898KY N8K0939KY N8K0971KY N8K0983KY N8K0996KY N8K1023KY N8K1063KY N8L0016KY N8L0072KY N8L0073KY N8L0099KY N8L0163KY N8L0204KY N8L0234KY N8L0283KY N8L0327KY N8L0351KY N8L0368KY N8L0440K… (truncated, 5872 characters total — see the official FDA record for the full value)
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
N8L0311KY N8M0063KY
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
N6C0533UX N6C0582UX N6C0657UX N6C0681UX N6E0115UX N6E0116UX N6E0976UX N6E0977UX N6E0978UX N6E0979UX N6F0045UX N6F0046UX N6F0047UX N6F0048UX N6F0049UX N6F0050UX N6F0295UX N6F0503UX N6F0504UX N6F0505UX N6F0506UX N6F0507UX N6F0508UX N6F0509UX N6F0748UX N6F0758UX N6F0759UX N6F0760UX N6F0786UX N6F0787UX N6F0788UX N6G0068UX N6G0270UX N6G0271UX N6G0287UX N6G0288UX N6G0486UX N6G0499UX N6G0784UX N6G0785UX N6G0786UX N6H0105UX N6H0106UX N6H0107UX N6H0155UX N6H0156UX N6H0157UX N6H0173UX N6H0174UX N6H0298UX N6H0299UX N6H0302UX N6H0522UX N6H0693UX N6H0734UX N6H0909UX N6H0946UX N6J0040UX N6J0092UX N6K0302UX N6K0970UX N6K1067UX N6L0152UX N6M0328UX N7A0170UX N7C0475X N7C1091X N7C1092X N7D0104X N8A0087X N8D0035X N8D0225X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
N6E0176UX N6E0278UX N6E0584UX N6E0587UX N6E0589UX N6E0590UX N6E0975UX N6F0141UX N6F0142UX N6F0143UX N6F0144UX N6F0340UX N6F0341UX N6F0342UX N6F0343UX N6F0436UX N6G0033UX N6G0034UX N6G0035UX N6G0036UX N6G0037UX N6G0038UX N6G0125UX N6G0744UX N6H0757UX N6J0436UX N6K0010UX N6K0372UX N6K0415UX N6K0990UX N6K0991UX N6K1110UX N7C0111X N7C0381X N7C0499X N7C0611X N7D0303X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2019

EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

ALL 50 STATES
▸Full report

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

Recall #:
82950
Lot/product code:
lots N4D0328KX N4D0338KX N4E0796KX N4E0846KX N4E0980KX N4E1018KX N4E1059KX N4E1173KX N4E1269KX N4E1654KX N4E1655KX N4G0523KX N4G1541KX N4H0078KX N4J0215KX N4J0250KX N4J0271KX N4J1002KX N4J1217KX N4J1247KX N4K1465KX N4M0921KX N5B0285KX N5B0340KX N5B0417KX N5B0484KX N5B0680KX N5D0467KX N5D0497KX N5D0550KX N5D0609KX N5D0660KX N5D0736KX N5D0765KX N5D1008KX N5E0068KX N5E0143KX N5E0297KX N5E0727KX N5E0756KX N5F0096KX N5F1223KX N5F1382KX N5G0244KX N5G0329KX N5G0339KX N5G0355KX N5G0405KX N5G0414KX N5G0809KX N5G0868KX N5J1153KX N5J1201KX N5J1233KX N5K0045KX N5K0089KX N5K0115KX N5M0172KX N5M0662KX N5M0693KX N5M0732KX N5M0741KX N6A0913KX N6B0332KX N6C0462KX N6D0388KX N6D0474KX N6D0506KX N6E0078KX N6E0099KX N6E0117KX N6E0129KX N6E0366KX N6E0416KX N6F0039KX N6F0088KX N6F0156KX N6F0720KX N6F0780KX N6F0816KX N6G0099KX N6G0139KX N6G0191KX N6G0198KX N6G0213KX N6G0243KX N6G0280KX N6H0168KX N6H0247KX N6H0291KX N6H0327KX N6H0370KX N6H0433KX N6H0456KX N6H0466KX N6H0792KX N6H0827KX N6J0152KX N6J0185KX N6J0243KX N6J0476KX N6K0160KX N6K0209KX N6K0251KX N6K0293KX N6K0676KX N6K0739KX N6K0774KX N6K0824KX N6K0871KX N6K1137KX N6L0806KX N6L0814KRX N6L0909KX N6L0942KX N6L0944KX N6M0065KX N6M0095KX N6M0113KX N6M0134KX N6M0263KX N7A0293KX N7A0792KX N7B0070KX N7B0125KX N7B0154KX N7B0177KX N7B0885KX N7B0905KX N7B0946KX N7C0387KX N7C0405KX N7C0442KX N7C0485KX N7C0517KX N7C0775KX N7C0812KX N7C0857KX N7C0899KX N7C0927KX N7C0977KX N7C1014KX N7D0101KX N7D0135KX N7D0182KX N7D0226KX N7D0247KX N7D0264KX N7D0416KX N7D0473KX N7D0495KX N7D0538KX N7D0591KX N7D0918KX N7D0945KX N7E0372KX N7E0518KX N7E0565KX N7E0610KX N7E0920KX N7E0962KX N7F0093KX N7F0094KX N7F0186KX N7F0224KX N7F0662KX N7F0663KX N7F0696KX N7F0745KX N7F0822KX N7F1019KX N7F1052KX N7F1139KX N7G0016KX N7G0241KX N7G0279KX N7G0498KX N7G0790KX N7G0904KX N7H0012KX N7H0174KX N7H0315KX N7H0347KX N7H0419KX N7H0470KX N7H0520KX N7H0569KX N7H0712KX N7H0786KX N7H0957KX N7H1017KX N7H1057KX N7H1096KX N7H1141KX N7H1175KX N7H1187KX N7J0070KX N7J0099KX N7J0135KX N7J0174KX N7J0483KX N7J0508KX N7J0550KX N7J0636KX N7J0692KX N7J0858KX N7J0897KX N7J1014KX N7J1155KX N7K0008KX N7K0085KX N7K0087KX N7K0154KX N7K0225KX N7K0270KX N7K0272KX N7K0303KX N7K0307KX N7K0400KX N7K0443KX N7K0500KX N7K0544KX N7K0562KX N7K0711KX N7K0742KX N7K0783KX N7K0821KX N7K0904KX N7K0956KX N7K1052KX N7K1150KX N7K1181KX N7K1183KX N7L0057KX N7L0091KX N7L0132KX N7L0361KX N7L0403KX N7L0431KX N7L0475KX N7L0592KX N7L0811KX N7L0856KX N7L1004KX N7L1098KX N7M0100KX N7M0132KX N7M0506KX N7M0554KX N7M0589KX N7M0592KX N7M0614KX N7M0620KX N7M0778KX N7M0918KX N7M0967KX N7M1000KX N8A0065KX N8A0203KX N8A0380KX N8A0381KX N8A0772KX N8A0960KX N8A1028KX N8A1050KX N8A1099KX N8A1119KX N8B0114KX N8B0137KX N8B0204KX N8B0571KX N8B0641KX N8B0666KX N8B0709KX N8B0769KX N8B0805KX N8B0849KX N8B0885KX N8B0905KX N8B0958KX N8B1009KX N8B1034KX N8B1048KX N8C0159KX N8C0324KX N8C0340KX N8C0470KX N8C0546KX N8C0589KX N8C0718KX N8C0777KX N8C0779KX N8C0816KX N8C1338KX N8C1339KX N8D0043KX N8D0083KX N8D0142KX N8D0311KX N8D0312KX N8D0394KX N8D0482KX N8D0483KX N8D0536KX N8D0594KX N8D0647KX N8D0694KX N8D1045KX N8D1067KX N8E0081KX N8E0149KX N8E0201KX N8E0233KX N8E0266KX N8E0321KX N8E0378KX N8E0431KX N8E0435KX N8E0498KX N8E0567KX N8E0612KX N8E0659KX N8E0699KX N8E0700KX N8E0725KX N8F0094KX N8F0183KX N8F0258KX N8F0307KX N8F0335KX N8F0347KX N8F0383KX N8F0428KX N8F0482KX N8F0658KX N8F0691KX N8F0773KX N8F0858KX N8F0879KX N8F0921KX N8F0976KX N8F1015KX N8F1046KX N8G0871KX N8G0911KX N8G0942KX N8G0980KX N8H0683KX N8H0735KX N8H0759KX N8J0819KX N8L0895KY N8M0168KRY N9A0665KRY N9A0954KRY N9B0348KY
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2019

Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.

Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge.

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

Recall #:
85091
Lot/product code:
Model Number CSS7200 (Guardian Connect App: iOS); Catalog Numbers: MMT-7821 (Guardian Connect Transmitter - GST4C); UPN - 00763000186333.  There are no assigned lot or serial numbers.
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2019

The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision refraction.

Lack of 510K clearance

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

Recall #:
83298
Lot/product code:
ALL
Recalling firm:
Opternative Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2019

LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM, Model Number H41212ZD; e. Vscan Extend Sector USB, Model Number H41212RR; f. Vscan Extend Sector Wi-Fi, Model Number H41212ZC Product Usage: Vscan Extend is a general- purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It s pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, and triage.

Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.

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

Recall #:
82938
Lot/product code:
a. Model Number H41212ZA, Serial Number (UDI): VH162494DA (01008406821216511118060021VH162494DA), VH162530R2 (01008406821216511118060021VH162530R2), VH160454PQ (01008406821216511118040021VH160454PQ), VH161212Z9 (01008406821216511118040021VH161212Z9), VH162305WM (Not Available), VH162300UE (Not Available), VH163166GF (Not Available), VH163170QD (Not Available), VH162011PE (01008406821216511118040021VH162011PE), VH163454AQ (01008406821216511118110021VH163454AQ), VH161912X9 (01008406821216511118040021VH161912X9), VH163489ED (01008406821216511118110021VH163489ED), VH160832WB (01008406821216511118040021VH160832WB), VH162896FQ (01008406821216511118100021VH162896FQ), VH163307IQ (Not Available), VH160748G4 (01008406821216511118040021VH160748G4), VH163100A6 (Not Available), VH162900GC (Not Available), VH163879G6 (Not Available), VH163278ZM (Not Available), VH162142TV (Not Available), VH163485KC (Not Available), VH163031AZ (Not Available), VH163175AT (Not Available), VH162126EN (Not Available), VH163659A8 (Not Available), VH1633048M (Not Available), VH163350EC (Not Available), VH163326UE (Not Available), VH163770L1 (Not Available), VH163784LD (Not Available), VH163036JA (Not Available), VH161216M7 (Not Available), VH1620432N (01008406821216511118040021VH1620432N), H41212RN, Serial Number (UDI): VH160254IY (Not Available), VH1607044U (Not Available), VH160176N2 (Not Available), VH1600406Z (Not Available), VH160053C5 (01008406821216511117020121VH160053C5), VH160485GP (Not Available), VH160181WQ (Not Available), VH161330TM (Not Available), VH160164PH (Not Available), VH16055084 (Not Available);   b .Model Number H41212RK, Serial Number (UDI): VH160462WV (Not Available), VH16092049 (Not Available);   c. Model Numbers H41212YZ, Serial Number (UDI): VH163439U9 (Not Available), VH163527ZC (Not Available), VH163066UJ (Not Available), VH163340NW (Not Available), VH163458CU (Not Available), VH163502LY (Not Available), VH163511T8 (Not Available), VH1636016Y (Not Available), VH163755YI (Not Available), VH163691TX (Not Available), VH1637399H (Not Available), VH163746S1 (Not Available), VH163764NN (Not Available), VH163763GE (Not Available), VH163759LP (Not Available), VH163765G2 (Not Available), VH163116N7 (Not Available), VH163044T8 (Not Available), VH162988WW (Not Available), VH163374LA (Not Available), VH163398MZ (Not Available), VH163428UW (Not Available), VH163415KB (Not Available), VH163446Z5 (Not Available), VH1634671E (Not Available), VH1636924B (Not Available), VH163744SF (Not Available), VH1637439Z (Not Available), VH1637388B (Not Available), VH163747I4 (Not Available), VH163741W3 (Not Available), VH163761IM (Not Available), VH16374052 (Not Available), VH163762TT (Not Available), VH163756TX (Not Available), VH1637451Y (Not Available), VH163766TJ (Not Available), VH163461K7 (Not Available), VH1634367P (Not Available), VH163383YB (Not Available), VH163493AE (Not Available), VH163477CV (Not Available), VH163445UT (Not Available), VH163676PS (Not Available), VH163671M1 (Not Available), VH1636685E (Not Available), VH163672YP (Not Available), VH1617429V (Not Available), VH163373TQ (Not Available), VH1634495A (Not Available), VH162698PH (Not Available), VH163113IV (Not Available), VH1633366P (Not Available), VH163002F8 (Not Available), VH163093EU (Not Available), VH16313978 (Not Available), VH163450F7 (Not Available), VH163751QX (Not Available), VH1632313N (Not Available), VH163748WX (Not Available), VH163754PU (Not Available), VH163742K9 (Not Available), VH1631245M (Not Available), VH162779KK (Not Available), H41212RL, Serial Number (UDI): VH1600189D (Not Available), VH1606843M (Not Available), VH1604606U (Not Available);   d. Model Number H41212ZD, Serial Number (UDI): VH1505638R (Not Available), VH150582C6 (Not Available), VH150663J5 (Not Available), VH150553A2 (Not Available);   e. Model Number H41212RR, Serial Number (UDI): VH150282CY (Not Available);   f. Model Number H41212ZC, Serial Number (UDI): VH150657SF (Not Available)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2019

The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.

Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line

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

Recall #:
88162
Lot/product code:
Lot Number: 2000401997  Unique Device Identifier (UDI) 08717872021294
Recalling firm:
Dutch Ophthalmic USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 23, 2019

Various products which were contract sterilized.

The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.

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

Recall #:
83001
Lot/product code:
Product Number (Lot Code):   1. G26862 (W3915653);   2. 8065751801 (15027297X-2015-06);   3. E7924 (HD1206703);   4. MCFK64 (MBKY190);   5. PCB502090 (16105672, 17525844);   6. PCB602090 (17766962, 17716501, 17505067, 17465154, 17339717, 17191941, 16536005, 15473410, 15441264, 16685888);   7. PCB702090 (16722293);   8. 277-10-50 (12094017);   9. 420024 (73B1500332);   10. 160636 (1202143, 1109213),   11. 160656 (1208163);   12. 7210424 (50506601);   13. AD750-KE40 (169-16), AD750-KE35 (182-16);   14. AD750-KE30 (102-16);   15. AD750-KE35 ( 118-16);   16. 614-481 (648221);   17. 76353200M (208992282, 207180152, 206969148, 206110579);   18. ASHA4250-01 (2004847);   19. GN1000 (9592565);   20. GN1500 (9916746);   21. SK200 (9577286);   22. GN2000 (9909194);   23. 9-AVP2-014 (1204040241);   24. 9-AVP2-016 (1201055704);   25. 401814RMC (35227834);   26. EICA5872-01 (1035512, 1049334, 1046764, 1050636);   27. 1011895H (141110A081);   28. 10031 (AM043619);   29. 424-7020W (17022849);   30. 424-5020W (17144227);   31. 115321 (HUUG0824), 115311 (HUTJ0689);   32. 96830-012 (12071254);   33. 96880-021 (2016120999);   34. OMS-T10BT ( P6J0204X, P6M0586X, P6H0631X);   35. 113230 (HUZH2232, HUZF1409, HUZI1854);   36. 681 (HUWB1603 );   37. S11886001 (HUWB1085);   38. G09691 (5335591);   39. G27023 (5094825);   40. G11672 (5425109, 5201291);   41. KD-V431M-0720 (73V, 72V, 76V);   42. KD-V411M-0730 (71V, 6ZV);   43. 8065750352 (1642344H);   44. 260-120 (15603764);   45. G53025 (4414833);   46. 82-1735 (CNCDBF);   47. 134450 (HUWA0947, HUVJ0726, HUVA1707);   48. CQF7554 (REYF0349);   49. CS40G (F4PE3M, F4PF8T);   50. M00530880 (G65382, G43088);   51. M00530870 (3888336, 788930, G43096, G59523);   52. G22732 (W3627617, W3665361, W353500, W3655212, W3531994);   53. G21765 (W3775367, W3611934);   54. 2124 (MN14080, MN13391);   55. 2296-100-216 (12034017);   56. PCB802090 (17747960);   57. 112750 (HUVJ1411, HUVF1668, HUUJ1326, HUTG1189, HUTE0455, HUSL1081);   58. 70138014 (531003018);   59. 70138001 (619552823);   60. 70138033 (640797753);   61. D-201-12704 (46K);   62. 24009 (2014011549);   63. G25671 (C1305047, C1314474, C1320703);   64. G25672 (C1162486, C1160026);   65. 5614 (20249064);   66. 91-12504 (6000004655);   67. SRK30 (MO27683);   68. 105-5092-150 (A096597);   69. ECR60W (L4EE9G, J4AE6D, K4DP4M, K4CC4H);   70. EC45A (K4CZ96);   71. EGIA45AMT (N2E0120ULX);   72. 30453 (N9L0087);   73. 30453 (N9A14);   74. 30453 (N2F0101LX);   75. 30453 (N2B0429LX);   76. 30453 (N1L0731LX);   77. 30453 (N1H0786LX);   78. 30453 (N1H0728LX);   79. 30453 (N5E0943KX);   80. 30453 (N1H0296LX);   81. 30453 (N1G0663LX);   82. 30453 (N1F0631LX);   83. 30453 (N0L0261);   84. 30453 (N0K0525);   85. 30453 (N1C0147LX);   86. 30453 (N3C0249LX);   87. 30453 (N2K0152LX);   88. 30453 (N2J0639LX);   89. 30453 (N4L0080KX);   90. 30453 (N2B0265LX);   91. 30453 (N1M0234LX);   92. 30453 (N1H0494LX);   93. 30453 (N1D0605LX);   94. 30453 (N9G0020);   95. 30453 (N8C413);   96. 30453 (N3F0179LX);   97. 30453 (N3B0327LX);   98. 30453 (N2F0340LX);   99. 30453 (N3E0189LX);   100. 30453 (N2C0297LX);   101. 30453 (N1L0474LX);   102. 30453 (N1G0249LX);   103. 30453 (N3D0092LX);   104. 30453 (N2F0194LX);   105. 30453 (N1F0422LX);   106. 30453 (N0F0164);   107. 30453 (N2B0529LX);   108. 30453 (N1F0767LX);   109. 173016 (N2F0618X);   110. 174601 (P2J0627X);   111. 30453 (N3C0405LX);   112. 30453 (N3A0707LX);   113. 30453 (N3A0221LX);   114. 30453 (N2K0401LX);   115. 30453 (N2G0538LX);   116. 30453 (N1M0112LX);   117. 30453 (N1H0900LX);   118. ECS33A (J4AT7Z, J4AG4G);   119. VH-3200 (25126202);   120. M00582080 (925804);   121. 711145 (1412697);   122. ATS45 (K4C81P);   123. 168190 (18673916);   124. 1000-90 (ELV32219V, ELV32215V);   125. G12830 (5204864);   126. OMS-XB2 (P6E0652X);   127. 3932 (20769076);   128. G11638 (5138842);   129. G30393 (U2102887, U2018952);   130. CBM320010 (16933371);   131. CBM325010 (15280044);   132. CBM325006 (13530853);   133. CBM330006 (16816611);   134. CBM340010 (17078794);   135. CBM340006 (EH5796);   136. 375-940-000 (12117CE2);   137. G49572 (W3357124, W3908339, W3816378);   138. G48277 (W3905583, W3915008, W3989699);   139. G48278 (W3852820, W3835461, W3856129, W3849232, W3864789);   140. G50977 (W3797199, W3771825, W3763156);   141. G31527 (C1287719, C1212820);   142. G31551 (C1384600);   143. G21613 (W3621261, W3746570, W3920476);   144. G21475 (C1103316, C1136032), G21478 (C1222618, C1264137), G21479 (C1291590, C1231802, C1231802, G21480 (C1176271, C1215997, 1404674, C1406615);   145. G21578 (C1168847, C1193440, G21578 (C1349288);   146. G22190 (C1133441, C1181667);   147. G22206 (C1303007, C1151429);   148. G22212 (C1226620, G22212 (C1333128);   149. G22209 (C1159612, C1195005, C1401555);   150. G22210 (C1263370, C1137419, C1398095);   151. G21575 (C1181665, C1264138, C1269765)… (truncated, 13277 characters total — see the official FDA record for the full value)
Recalling firm:
Anewmed Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 23, 2019

Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.

During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated.

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

Recall #:
85050
Lot/product code:
ObalonR Balloon System with Navigation and Touch. UDI: 00859810006104; Model No.: Model 4300 Touch Dispenser;Software version 02.00.00.0076. Serial Numbers: 0097, 0076, 0077, 0078, 0079, 0080, 0082, 0083, 0084, 0085, 0086, 0087 0088, 0089, 0090, 0091, 0092, 0093, 0094, 0095, 0097, 0099, 0100, 0101, 0102, 0103, 0104, 0106, 0107, 0109, 0111, 0112, 0113, 0115, 0118, 0119, 0120, 0121, 0122, 0125, 0126, 0127, 0129, 0130, 0133.
Recalling firm:
Obalon Therapeutics Inc
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Class IHigh risk
FoodUndeclaredRecalled May 27, 2019

"DEEP***GOLDEN RAISINS***NET WT***198g/7oz***DEEP FOODS, INC. UNION, NJ 07083"

Deep Foods Inc., 1090 Springfield Road, Union, NJ-07083 is initiating a recall of Deep Golden Raisins because of not listed on the label sulfites.

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

Recall #:
F-1981-2019
Lot/product code:
This recall covers 7oz, 14oz, and 28oz sizes with the following UPC codes: 7oz: 011433133432 14oz: 011433133449 28oz: 011433433457
Recalling firm:
Deep Foods Inc
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