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Recalls affecting Guam

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

15,987 recalls found

Just announced

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

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

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

ALL 50 STATES
Full report

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

Recall #:
88058
Lot/product code:
All Serial Numbers  Material Numbers: DSX9999H11 INX9999H19 RINX9999H19
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 18, 2021

Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.

ALL 50 STATES
Full report

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

Recall #:
88426
Lot/product code:
Serial Numbers: 1709VG0832 1803CE0680 1803CE0681 1803CE0682 1803CE0683 1803CE0684 1803CE0685 1803CE0686 1803CE0687 1803CE0688 1803CE0689 1803CE1024 1803CE1025 1803CE1026 1803CE1027 1803CE1028 1803CE1029 1803CE1030 1803CE1031 1803CE1032 1803CE1033 1803CE1084 1803CE1085 1803CE1086 1803CE1087 1804CE0171 1804CE0172 1804CE0173 1804CE0174 1804CE0175 1804CE0176 1804CE0177 1804CE0178 1804CE0179 1804CE0180 1804CE0292 1804CE0293 1804CE0294 1804CE0295 1804CE0296 1804CE0297 1804CE0298 1804CE0299 1804CE0300 1804CE0301 1805CE0298 1805CE0299 1805CE0300 1805CE0301 1805CE0302 1805CE0303 1805CE0304 1805CE0305 1805CE0306 1805CE0307 1805CE0362 1805CE0363 1805CE0364 1805CE0365 1805CE0366 1805CE0367 1805CE0368 1805CE0369 1805CE0370 1805CE0371 1805CE0805 1805CE0806 1805CE0807 1805CE0808 1805CE0809 1805CE0810 1805CE0811 1805CE0812 1805CE0813 1805CE0814 1806CE0013 1806CE0014 1806CE0015 1806CE0016 1806CE0017 1806CE0018 1806CE0019 1806CE0020 1806CE0021 1806CE0022 1806CE0318 1806CE0319 1806CE0320 1806CE0321 1806CE0322 1806CE0323 1806CE0324 1806CE0325 1806CE0326 1806CE0327 1806CE0328 1806CE0329 1806CE0330 1806CE0331 1806CE0332 1806CE0333 1806CE0334 1806CE0335 1806CE0336 1806CE0337 1807CE0343 1807CE0344 1807CE0345 1807CE0346 1807CE0347 1807CE0348 1807CE0349 1807CE0350 1807CE0351 1807CE0425 1807CE0426 1807CE0427 1807CE0428 1807CE0429 1807CE0430 1807CE0431 1807CE0432 1807CE0433 1807CE0434 1807CE0467 1807CE0468 1807CE0469 1807CE0470 1807CE0471 1807CE0472 1807CE0473 1807CE0474 1807CE0475 1807CE0476 1807CE0551 1807CE0552 1807CE0553 1807CE0554 1807CE0555 1807CE0556 1807CE0557 1807CE0558 1807CE0559 1807CE0560 1807CE0601 1807CE0602 1807CE0603 1807CE0604 1807CE0605 1807CE0606 1807CE0607 1807CE0608 1807CE0609 1807CE0610 1807CE0658 1807CE0659 1807CE0660 1807CE0661 1807CE0662 1807CE0663 1807CE0664 1807CE0665 1807CE0666 1807CE0667 1807CE0825 1807CE0826 1807CE0827 1807CE0828 1807CE0829 1807CE0830 1807CE0831 1807CE0832 1807CE0833 1807CE0834 1807CE0915 1807CE0916 1807CE0917 1807CE0918 1807CE0919 1807CE0920 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1808CE0804 1808CE0805 1808CE0806 1808CE0859 1808CE0860 1808CE0861 1808CE0862 1808CE0863 1808CE0864 1808CE0865 1808CE0866 1808CE0867 1808CE0868 1808CE0890 1808CE0891 1808CE0892 1808CE0893 1808CE0894 1808CE0895 1808CE0896 1808CE0897 1808CE0898 1808CE0899 1808CE0972 1808CE0973 1808CE0974 1808CE0975 1808CE0976 1808CE0977 1808CE0978 1808CE0979 1808CE0980 1808CE0981 1809CE0094 1809CE0095 1809CE0096 1809CE0097 1809CE0098 1809CE0099 1809CE0100 1809CE0101 1809CE0102 1809CE0103 1809CE0134 1809CE0135 1809CE0136 1809CE0137 1809CE0138 1809CE0139 1809CE0140 1809CE0141 1809CE0142 1809CE0143 1809CE0461 1809CE0462 1809CE0463 1809CE0464 1809CE0465 1809CE0466 1809CE0467 1809CE0468 1809CE0469 1809CE0470 1809CE0471 1809CE0472 1809CE0504 1809CE0505 1809CE0506 1809CE0507 1809CE0508 1809CE0509 1809CE0510 1809CE0511 1809CE0512 1809CE0513 1809CE0631 1809CE0632 1809CE0633 1809CE0634 1809CE0635 1809CE0636 1809CE0637 1809CE0638 1809CE0639 1809CE0640 1809CE0735 1809CE0736 1809CE0737 1809CE0738 1809CE0739 1809CE0740 1809CE0741 1809CE0742 1809CE0743 1809CE0744 1809CE0810 1809CE0811 1809CE0812 1809CE0813 1809CE0814 1809CE0815 1809CE0816 1809CE0817 1809CE0818 1809CE0819 1809CE0974 1809CE0975 1809CE0976 1809CE0977 1809CE0978 1809CE0979 1809CE0980 1809CE0981 1809CE0982 1809CE0983 1809CE1039 1809CE1040 1809CE1041 1809CE1042 1809CE1043 1809CE1044 1809CE1045 1809CE1046 1809CE1047 1809CE1048 1809CE1121 1809CE1122 1809CE1123 1809CE1124 1809CE1125 1809CE1126 1809CE1127 1809CE1128 1809CE1129 1809CE1130 1809CE1211 1809CE1212 1809CE1213 1809CE1214 1809CE1215 1809CE1216 1809CE1217 1809CE1218 1809CE1219 1809CE1220 1811CE0620 1811CE0621 1811CE0622 1811CE0623 1811CE0624 1811CE0625 1811CE0626 1811CE0627 1811CE0628 1811CE0629 1811CE1006 1811CE1007 1811CE1008 1811CE1009 1811CE1010 1811CE1011 1811CE1012 1811CE1013 1811CE1014 1811CE1015 1811CE1113 1811CE1114 1811CE1115 1811CE1116 1811CE1117 1811CE1118 1811CE1119 1811CE1120 1811CE1121 1811CE1122 1811CE1123 1811CE1124 1812CE0499 1812CE0500 1812CE0501 1812CE0502 1812CE0503 1… (truncated, 12115 characters total — see the official FDA record for the full value)
Recalling firm:
WOM World of Medicine AG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 18, 2021

Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.

ALL 50 STATES
Full report

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

Recall #:
88127
Lot/product code:
Model V60 Plus Ventilator: P/N 1138747 and 1137276;  US System Serial Number/UDI Code: 100363973/ ; 100366525/ ; 100366542/ ; 100371876/ (01)00884838090996(21)100371876; 100373102/ (01)00884838090996(21)100373102; 100374459/ (01)00884838090996(21)100374459; 100376350/ (01)00884838090996(21)100376350; 100377311/ (01)00884838090996(21)100377311; 100377324/ (01)00884838090996(21)100377324; 100380441/ (01)00884838090996(21)100380441; 100382407/ (01)00884838090996(21)100382407; 100382452/ (01)00884838090996(21)100382452; 100382461/ (01)00884838090996(21)100382461; 100384413/ (01)00884838090996(21)100384413; 100384748/ (01)00884838090996(21)100384748; 100385425/ (01)00884838090996(21)100385425; 100385428/ (01)00884838090996(21)100385428; 100385429/ (01)00884838090996(21)100385429; 100385447/ (01)00884838090996(21)100385447; 100385529/ (01)00884838090996(21)100385529; 100386081/ (01)00884838090996(21)100386081; 100386137/ (01)00884838090996(21)100386137; 100386179/ (01)00884838090996(21)100386179; 100389986/ (01)00884838090996(21)100389986; 100390076/ (01)00884838090996(21)100390076; 100392652/ (01)00884838090996(21)100392652; 100392801/ (01)00884838090996(21)100392801; 100392809/ (01)00884838090996(21)100392809; 100392899/ (01)00884838090996(21)100392899; 100393482/ (01)00884838090996(21)100393482; 100393544/ (01)00884838090996(21)100393544; 100393555/ (01)00884838090996(21)100393555; 100393571/ (01)00884838090996(21)100393571; 100393741/ (01)00884838090996(21)100393741; 100393749/ (01)00884838090996(21)100393749; 100395503/ (01)00884838090996(21)100395503; 100395807/ (01)00884838090996(21)100395807; 100396158/ (01)00884838090996(21)100396158; 100396540/ (01)00884838090996(21)100396540; 100396598/ (01)00884838090996(21)100396598; 100396747/ (01)00884838090996(21)100396747; 100398796/ (01)00884838090996(21)100398796; 100398852/ (01)00884838090996(21)100398852; 100403796/ (01)00884838090996(21)100403796; 100403798/ (01)00884838090996(21)100403798; 100403813/ (01)00884838090996(21)100403813; 100403828/ (01)00884838090996(21)100403828; 100403830/ (01)00884838090996(21)100403830; 100403832/ (01)00884838090996(21)100403832; 100403842/ (01)00884838090996(21)100403842; 100404111/ (01)00884838090996(21)100404111; 100404113/ (01)00884838090996(21)100404113; 100404114/ (01)00884838090996(21)100404114; 100404115/ (01)00884838090996(21)100404115; 100404117/ (01)00884838090996(21)100404117; 100404118/ (01)00884838090996(21)100404118; 100404124/ (01)00884838090996(21)100404124; 100404131/ (01)00884838090996(21)100404131; 100404192/ (01)00884838090996(21)100404192; 100405715/ (01)00884838090996(21)100405715; 100405718/ (01)00884838090996(21)100405718; 100405741/ (01)00884838090996(21)100405741; 100405742/ (01)00884838090996(21)100405742; 100406077/ (01)00884838090996(21)100406077; 100406208/ (01)00884838090996(21)100406208; 100408124/ (01)00884838090996(21)100408124; 100408126/ (01)00884838090996(21)100408126; 100408129/ (01)00884838090996(21)100408129; 100408133/ (01)00884838090996(21)100408133; 100408137/ (01)00884838090996(21)100408137; 100408144/ (01)00884838090996(21)100408144; 100408149/ (01)00884838090996(21)100408149; 100408419/ (01)00884838090996(21)100408419; 100408882/ (01)00884838090996(21)100408882; 100408886/ (01)00884838090996(21)100408886; 100408899/ (01)00884838090996(21)100408899; 100408901/ (01)00884838090996(21)100408901; 100409389/ (01)00884838090996(21)100409389; 100409394/ (01)00884838090996(21)100409394; 100409537/ (01)00884838090996(21)100409537; 100409560/ (01)00884838090996(21)100409560; 100409712/ (01)00884838090996(21)100409712; 100409734/ (01)00884838090996(21)100409734; 100409932/ (01)00884838090996(21)100409932; 100409937/ (01)00884838090996(21)100409937; 100410001/ (01)00884838090996(21)100410001; 100410024/ (01)00884838090996(21)100410024; 100412283/ (01)00884838090996(21)100412283; 100412293/ (01)00884838090996(21)100412293; 100412450/ (01)00884838090996(21)100412450; 100412596/ (01)00884838090996(21)100412596; 100412940/ (01)00884838090996(21)100412940; 100412943/ (01)00884838090996(21)100412943; 100412976/ (01)00884838090996(21)100412976; 100412980/ (01)00884838090996(21)100412980; 100412981/ (01)00884838090996(21)100412981; 100413021/ (01)00884838090996(21)100413021; 100413027/ (01)00884838090996(21)100413027; 100413028/ (01)00884838090996(21)100413028; 100413030/ (01)00884838090996(21)100413030; 100413033/ (01)00884838090996(21)100413033; 100413524/ (01)00884838090996(21)100413524; 100413571/ (01)00884838090996(21)100413571; 100413663/ (01)00884838090996(21)100413663; 100413670/ (01)00884838090996(21)100413670; 100413672/ (01)00884838090996(21)100413672; 100413837/ (01)00884838090996(21)100413837; 100413905/ (01)00884838090996(21)100413905; 100413990/ (01)00884838090996(21)100413990; 100414030/ (01)00884838090996(21)100414030; 100414034/ (01)00884838090996(21)100414034; 100414256/ (01)00884838090996(21)100414256; 100414346/ (01)00884838090996(21)100414346; 100414349/ (01)00884838090996(21)1… (truncated, 21466 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 18, 2021

Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.

ALL 50 STATES
Full report

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

Recall #:
88127
Lot/product code:
Model V60 Ventilator: P/N 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076716, 1137292  US System Serial Number/UDI Code: 100351272 (01)00884838020054(21)100351272 100006691  100193211  100220566 (01)00884838020054(21)100220566 100313757 (01)00884838020054(21)100313757 100313412 (01)00884838020054(21)100313412 100080135  100081569  100110187  100121703  100013472  100230650 (01)00884838020054(21)100230650 100374411 (01)00884838020054(21)100374411 100054305  100068863  100188390  100181283  100030036  100030039  100030046  100030040  100043349  100030041  100037246  201029401 (01)00884838020054(21)201029401 100278366 (01)00884838020054(21)100278366 100088340  100131320  201030489 (01)00884838020054(21)201030489 100057026  100074563  201005638  201001514  100027860  201005635  100154662  100056752  100130449  100154846  100078004  100055123  100191452  100077709  100015080  100191788  100129710  100028046  100077079  201017909  100224361 (01)00884838020054(21)100224361 100043830  100024302  100133355  100077493  100077503  100039424  100177846  201011206  100076877  100191271  100152171  100056385  100120289  100262177 (01)00884838020054(21)100262177 100120262  100047561  100156074  100104165  100115189  201026331 (01)00884838020054(21)201026331 100057549  100133002  100258925 (01)00884838020054(21)100258925 201030702 (01)00884838020054(21)201030702 100040748  100290605 (01)00884838020054(21)100290605 100044617  100147649  100038426  100049697  100318142 (01)00884838020054(21)100318142 100062636  100047178  100130954  100017106  100172675  100265434 (01)00884838020054(21)100265434 100097540  100174538  100028947  201033184 (01)00884838020054(21)201033184 100158623  100184938  100184879  100094731  100325804 (01)00884838020054(21)100325804 100117611  100048641  100267973 (01)00884838020054(21)100267973 100148068  100416709 (01)00884838020054(21)100416709 100118800  100177855  100023735  100025030  100040300  100279146 (01)00884838020054(21)100279146 100008228  100054315  100008224  100008438  100258476 (01)00884838020054(21)100258476 100008146  100006219  100063484  100074097  100349391 (01)00884838020054(21)100349391 100064083  100187263  100168073  100280881 (01)00884838020054(21)100280881 100256575 (01)00884838020054(21)100256575 100245312 (01)00884838020054(21)100245312 100038024  100088492  100017237  100039542  100245557 (01)00884838020054(21)100245557 100275362 (01)00884838020054(21)100275362 100053364  100190401  100237792 (01)00884838020054(21)100237792 100059977  100360168 (01)00884838020054(21)100360168 100268194 (01)00884838020054(21)100268194 100147646  100063411  201024993 (01)00884838020054(21)201024993 100112558  100113474  100266415 (01)00884838020054(21)100266415 100031093  100037777  100051583  100105808  100411005 (01)00884838020054(21)100411005 100148200  100376334 (01)00884838020054(21)100376334 100057733  100091066  100122067  100073597  100057124  100146619  100302964 (01)00884838020054(21)100302964 100091075  100120976  100147661  100032534  MX0000332 (01)00884838020054(21)MX0000332 201028104 (01)00884838020054(21)201028104 100130950  100360674 (01)00884838020054(21)100360674 100094723  201032131 (01)00884838020054(21)201032131 100347825 (01)00884838020054(21)100347825 100043722  100114570  100266417 (01)00884838020054(21)100266417 100043812  100312855 (01)00884838020054(21)100312855 100066482  100066913  100057973  100240908 (01)00884838020054(21)100240908 100360608 (01)00884838020054(21)100360608 100132982  100172584  100105301  MX0000811 (01)00884838020054(21)MX0000811 100049922  201014454  100045057  100119310  100279355 (01)00884838020054(21)100279355 100256638 (01)00884838020054(21)100256638 100379488 (01)00884838020054(21)100379488 100230368 (01)00884838020054(21)100230368 100012543  100058126  100095885  100072279  100074017  100028855  100272829 (01)00884838020054(21)100272829 100027744  100015201  100058120  100134489  100065687  100192989  100266252 (01)00884838020054(21)100266252 201030363 (01)00884838020054(21)201030363 100080380  100060798  100010101  100073350  100050880  201019491  100034592  100059844  100292155 (01)00884838020054(21)100292155 100065690  100240306 (01)00884838020054(21)100240306 100092442  100084643  100063471  100091560  100184278  201008243  100051577  100292954 (01)00884838020054(21)100292954 100095009  100092540  100170409  100251069 (01)00884838020054(21)100251069 100184876  201022432 (01)00884838020054(21)201022432 100249314 (01)00884838020054(21)100249314 100188585  100141803  100028067  100265833 (01)00884838020054(21)100265833 100112787  100238524 (01)00884838020054(21)100238524 100023629  100191117  100023474  100060967  100066569  100148673  100092302  100042111  201029330 (01)00884838020054(21)201029330 100094822  100150330  100084010  100113272  100378839 (01)00884838020054(21)100378839 100104483  100043449  100082989  100132958  100090020  100031686  100029521  100084770  100042021  100080984  100091092  100096788  1… (truncated, 35919 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
a) REF 3779422, Lot 00A1160635 b) REF 3769522, Lot 00A1160656 c) REF 3708522, Lot 00A1160638
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
a) REF 3832572: Lot 11T80189 b) REF 3842572, Lot 11T80198 c) REF 3821572, Lot 11T80149 d) REF 3833572, Lot 11T80292 e) REF 3831572, Lot 12T80230 f) REF 3810572, Lot 12T80302 g) REF 3852572, Lot 12T80349
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
a) REF 3738522, Lot 00A2160813 b) REF 3738822, Lot 00A1160822
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
a) REF 3836272, Lot 11T80188 b) REF 3814272, Lot 11T80272 c) REF 3845272, Lot 12T80147 d) REF 3856272, Lot 12T80347
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
Lot 00A1160806
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
a) REF 3814773, Lot 11T00118 b) REF 3835773, Lot 11T00119 c) REF 3825773, Lot 11T00120 d) REF 3837773, Lot 11T00121 e) REF 3846773, Lot 11T00122 f) REF 3831473, Lot 11T00142 g) REF 3842473, Lot 11T00143 h) REF 3821473, Lot 11T00146 i) REF 3832473, Lot 11T00147 j) REF 3833473, Lot 11T00148 k) REF 3821573, Lot 11T00177 l) REF 3831573, Lot 11T00178 m) REF 3833573, Lot 11T00179 n) REF 3824773, Lot 11T00230 o) REF 3804773, Lot 11T00231 p) REF 3845773, Lot 11T00232 q) REF 3811473, Lot 11T05089 r) REF 3836773, Lot 11T05136 s) REF 3843473, Lot 11T05166 t) REF 3800473, Lot 11T10007 v) REF 3842573, Lot 12T00180 w) REF 3832573, Lot 11T10015 x) REF 3847773, Lot 11T10016 y) REF 3800573, Lot T1010018
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
a) REF 3832072, Lot 11T80190 b) REF 3810072, Lot 11T80303 c) REF 3842072, Lot 12T80342 d) REF 3852072, Lot 12T80348
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA SELFSAFE PUR T, I.V. Catheter:

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
REF 3738522, Lot 00A2160813 REF 3738822, Lot 00A1160822
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
REF 3708122, Lot 00A1160627
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA Self Safe, I.V. Catheter REF 3738222

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
REF 3738222, Lot 00A1160625
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
Full report

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

Recall #:
88234
Lot/product code:
a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std Backrest, Electric; Serial Numbers: 10001-SC2-20 to 10135-SC2-20; 10001-SC2-21 to 10240-SC2-21. Model Number: CHAIR-0-SC3-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Manual; Serial Numbers: 10116-SC3-20 to 10145-SC3-20; 10236-SC3-20 to 10295-SC3-20; 10001-SC3-21 to 10090-SC3-21; 10271-SC3-21 to 10360-SC3-21; 10001-SC3-20 to 10115-SC3-20; 10146-SC3-20 to 10235-SC3-20. Model Number: CHAIR-0-SC4-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Electric; Serial Numbers: 10001-SC4-20 to 10030-SC4-20.

The firm has identified a potential for the backrest to become detached from the chair.

ALL 50 STATES
Full report

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

Recall #:
88441
Lot/product code:
Serial Numbers (Domestically distributed) 10001-SC3-20 to 10115-SC3-20 10146-SC3-20 to 10235-SC3-20
Recalling firm:
Accora Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.

ALL 50 STATES
Full report

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

Recall #:
96078
Lot/product code:
Soft ware version 1.49.02 UDI: +B595BSM20500/\$\$7V1.49.02/16D20200504S and Software version 1.52.00 UDI: +B595BSM20500/\$\$7V1.52.00/16D20210305K
Recalling firm:
Murata Vios, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled June 22, 2021

Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Domingo, Dominican Republic UPC 7 487040 301587

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

ALL 50 STATES
Full report

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

Recall #:
D-0691-2021
Lot/product code:
Batch Number # 079932-4611-05-J, exp. date May 2022
Recalling firm:
Ardil Comercial S.R.L.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 22, 2021

QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by HoYu (US) Logistics Inc UPC 6 926645 716288

Weaker than it should be

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-0643-2021
Lot/product code:
Lot # Q20200320, exp. date 03/19/2022
Recalling firm:
HOYU(US) LOGISTICS INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2021

TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm; TJC4011 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 11G x 10cm; TJM4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm; TJC4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm;

Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

ALL 50 STATES
Full report

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

Recall #:
88314
Lot/product code:
Catalog Number//UDI: TJM6008/(01)10885403044595(17)241031(10)0001330707; TJC3513/(01)1088540344014(17)241031(10)0001330400; TJM4011/(01)10885403044588(17)241031(10)0001330949; TJC4011/(01)10885403044052(17)241031(10)0001331232; TJM4008/(01)10885403044564(10)0001331230(17)241031; TJC4008/(01)10885403044038(17)241130(10)0001334951;  Serial Numbers: 0001330707; 0001330400; 0001330400; 0001330400; 0001331232; 0001331230; 0001334951;
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2021

TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm

Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

ALL 50 STATES
Full report

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

Recall #:
88314
Lot/product code:
Catalog Number/UDI: TIN3018/(01)10885403043819(17)241031(10)0001330956; TIN3015/(01)10885403043796(17)241031(10)0001331229;  Serial Numbers: 0001330956; 0001331229;
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2021

EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm

Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

ALL 50 STATES
Full report

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

Recall #:
88314
Lot/product code:
Catalog Number/UDI: EJM4011/ (01)10885403464157(17)241031(10)0001330769; Serial Numbers: 0001330769; 0001331231;
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2021

CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.

There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.

ALL 50 STATES
Full report

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

Recall #:
88621
Lot/product code:
All Serial Numbers
Recalling firm:
CardioQuip, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2021

KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005

Product label intended for the European community was distributed to the USA market via their US distribution organization

ALL 50 STATES
Full report

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

Recall #:
88427
Lot/product code:
Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner, +5mm Lateralized, G0, 22mm ID. Orthopedic hip implant component.

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

ALL 50 STATES
Full report

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

Recall #:
88126
Lot/product code:
All serial numbers. UDI-DI numbers: 10885862024213, 10885862024220, 10885862024237
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)