BIGNOPE
Ko-fi

Recalls affecting Rhode Island

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

16,286 recalls found
NewOld
High RiskLow Risk
AllClear

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/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

▸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 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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/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 July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
▸Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT80X Lot #: TS19060095, TS19060169, TS19060328, TS19060357, TS19070100, TS19080183, TS19080225, TS19080308, TS19090043, TS19090188, TS19090292, TS19100150, TS19100214, TS19100282, TS19110050, TS19110115, TS19110295, TS19110334, TS19120049, TS20050165  Additional Affected Lots as of 10/20/20: TS20040334, TS20040358, TS20040359, TS20050106, TS20050322, TS20060026, TS20060084
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
▸Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT85X Lot #: TS19060044, TS19060122, TS19060189, TS19080111, TS19080184, TS19080227, TS19090008, TS19090127, TS19100079, TS19100220, TS19110109, TS19110285, TS19110331, TS19120316, TS20050031, TS20050139  Additional Affected Lots as of 10/20/20: TS20050169, TS20050262, TS20060005
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
▸Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT55X Lot #: TS19060338, TS19070077, TS19070176, TS19090164, TS19090248, TS19100272, TS19110080, TS20010146, TS20020202, TS20040092  Additional Affected lots as of 10/20/20: TS20040247, TS20050050, TS20050051, TS20050261, TS20060112, TS20060113, TS20070125
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
▸Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT75X Lot #: TS19060031, TS19060065, TS19060168, TS19060302, TS19080080, TS19080176, TS19080203, TS19080262, TS19090027, TS19090064, TS19090167, TS19090272, TS19100111, TS19100197, TS19100244, TS19100262, TS19110041, TS19110102, TS19110176, TS19110238, TS19120002, TS19120044, TS19120274, TS20020286, TS20030288, TS20040030, TS20040086, TS20050114  Additional Affected Lots as of 10/20/20: TS20040051, TS20040075, TS20040058, TS20040176, TS20040280, TS20040281, TS20040291, TS20050010, TS20050174, TS20050306, TS20050353, TS20060032, TS20060038, TS20060120, TS20060174, TS20060175, TS20060260, TS20050250
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
▸Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT90X Lot #: TS19080275, TS19090162, TS19090231, TS20010216, TS20030153  Additional Affected Lots of as 10/20/20: TS20040290, TS20050032, TS20060107  Additional Affected Lots as of 2/23/21: TS20040344
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
▸Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT70X Lot #: TS19060339, TS19070029, TS19070108, TS19070180, TS19070285, TS19080035, TS19080064, TS19080140, TS19080186, TS19080271, TS19090054, TS19090149, TS19090266, TS19100058, TS19100107, TS19100186, TS19100308, TS19110038, TS19110090, TS19110157, TS19110225, TS19120005, TS20030299, TS20040046  Additional Affected Lots as of 10/20/20: TS20040204, TS20040260, TS20040312, TS20050113, TS20050157, TS20050289, TS20050290, TS20050391, TS20060093, TS20060152, TS20060153, TS20060204, TS20060237, TS20060238, TS20060296, TS20060304, TS20060305, TS20070020, TS20070107
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

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-0080-2021
Lot/product code:
1931102AL
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

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-0081-2021
Lot/product code:
1931101AL
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

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-0079-2021
Lot/product code:
1931104AL
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

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-0082-2021
Lot/product code:
Lots ending in 1001,1002, 1003, 1004, 1005.
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

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-0078-2021
Lot/product code:
all lots
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 31, 2020

PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME PHAC1222 PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME PHAC1224 PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME PHAC1232 PROFEMUR NECK A/R 8DG SHORT COBALT CHROME PHAC1234 PROFEMUR NECK A/R 8DG LONG COBALT CHROME PHAC1242 PROFEMUR NECK A/R 15DG SHORT COBALT CHROME PHAC1244 PROFEMUR NECK A/R 15DG LONG COBALT CHROME PHAC1252 PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME PHA01202 PROFEMUR NECK NEUTRALSHORT SHORT PHA01204 PROFEMUR NECK NEUTRAL LONG PHA01206 PROFEMUR NECK NEUTRAL X LONG PHA01212 PROFEMUR NECK A/R VAR/VAL 2 SHORT PHA01214 PROFEMUR NECK A/R VAR/VAL 2 LONG PHA01222 PROFEMUR NECK A/R VAR/VAL 1 SHORT PHA01224 PROFEMUR NECK A/R VAR/VAL 1 LONG PHA01232 PROFEMUR NECK 8DG A/R SHORT PHA01234 PROFEMUR NECK 8DG A/R LONG PHA01236 PROFEMUR NECK 8DG A/R X LONG PHA01242 PROFEMUR NECK 15DG A/R SHORT PHA01244 PROFEMUR NECK 15DG A/R LONG PHA01252 PROFEMUR NECK 8DG VAR/VAL SHORT PHA01254 PROFEMUR NECK 8DG VAR/VAL LONG PHA01256 PROFEMUR NECK 8DG VAR/VAL X LONG PHA01262 PROFEMUR NECK 15DG VAR/VAL SHORT PHA01264 PROFEMUR NECK 15DG VAR/VAL LONG Intended Use: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR Hip System Package Insert with the most recent revision (150803-8).

ALL 50 STATES
▸Full report

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

Recall #:
86211
Lot/product code:
All lots 1431860 1435705 1430154 1431065 1431308 1436522 1437003 0298131491437686 06113732261437685 1286531651437687 1430775 1431243 1431309 1431622 1431825 1431864 1432439 1432440 1433425 1433430 1433432 1433433 1434152 1435449 1435602 1435699 1435700 1436524 1436526 1436556 1437004 W123831741436428 1433424 1434969 14080361437684 1433431 1434993 1436525 1436527 1436528 1438068 1438130 1435702 1437055 1438069 1438131 1438455 X013918551437840 14277201440118 1434151 1434965 1435450 1435701 1435727 1435728 1436529 1436557 1436713 1438245 1438609 1438456 1438775 1438776 0398262151439704 1435603 1436712 1438872 1439145 V072510101439739 W0989675B1439738 1437581 1437877 1438664 1438873 1439144 1439379 1439380 1439387 1439582 U06811981440149 U06811981440151 V062154321440171 V092442911440169 1432436 1434964 1436365 1439944 1439945 1439946 W063349591440289 W073506871440084 1437451 1437582 1438953 1439581 1439947 U11852411440150 V062154311440165 V072329521440166 W093590691440288 W09919661440428 W103727321440287 1435852 1436366 1440186 1436367 1433438 1434153 1436555 1437050 1437580 1440654 1436364 1436711 1440187 1438954 1440655 1437057 1437876 1438297 1438454 1439325 1439512 1439513 1440239 1439323 1439750 1439752 1440238 1440575 1440576 1441171 1439514 1441170 1441535 1439753 1442404 01010095631444294 01112878341444296 0197579261444305 0197610691444306 0197842261444320 0285403251444307 0285523101444308 0285562241444309 02895142011444310 0297967521444312 0485730671444289 06113570991444291 0686252461444293 0798931781444290 1441359 1441718 1442049 03010220831444429 03113107711444440 03113335641444441 03113336361444442 0374147011444444 0397842251444450 0397913511444451 0398054701444453 07113789351444150 08011853901444155 1439324 1441410 1441716 1441961 1441962 1442050 1442313 1442407 1426645 1441492 1442201 1442405 1442406 1443050 1443053 1444193 1443262 1443489 1443490 U04705491444408 V112725371443806 W103767491443808 X064183591443810 03010819061444439 0363229471444443 0385562251444446 0385670021444447 0385730661444449 05113531101443811 1444194 1444342 W053277871443804 1440184 1440185 1443263 1432950 1444631 1444902 1440189 1444632 1445653 1445921 1445654 1446056 03113263491447082 04113343381447081 10012317451447124 1444903 1446966 W113767461447122 W113767531447123 W113857491447121 1447399 1447599 1446055 1446287 1446288 1446968 01112894471448087 1440127 1445938 1446020 1446939 1447397 1447600 W113767521447939 0586023501448096 1446176 1447786 1447787 1448190 V112725451447945 1446052 1447215 1448058 1448059 1448060 1448061 1448063 1448064 1448191 1448192 1448927 1448928 01112886231449440 05113539081449442 05113565991449443 0598437561449701 06011499591449438 08011897241449439 0986935661449700 1074719851449436 1074766231449711 11012435971449434 12012613881449435 1446021 1446053 1446177 1446938 1446940 V122874111449452 14154801449569 1444905 1447216 1448382 01010147751449539 02112969061449756 02113041371449534 03113144021449766 03113338081449531 0398310121449537 05113533911449792 05113652461449791 06011555561449765 07011838171450002 11460621449632 1299867951449762 14064991449764 1444904 1447213 1448381 1449428 1449429 U03667141449793 U06779811449794 U07764831449795 U07764931449798 U09852421449799 U10852431449797 U111161981449836 U111162101449819 U121437931449820 V062017171449800 V082154331449451 V082154331449801 W023009161449812 W023087681449805 W023087711449821 W033145651449822 W043212111449802 W043212131449807 W053212141449813 W063277911449823 W063349591449803 W063349661449824 W073349611449808 W073349621449814 W073441571449815 W073506901449816 W093590661449817 W09888841449809 W0989685111449818 W103590651449810 W103727301449804 W103767501449811 W103767561449825 0786716701450491 1448969 1448923 1448924 1448970 05113533871450501 1447214 1450118 1450206 1450208 W023143321450794 W033145591450795 0197842241451697 0398146081451827 04010969711451830 04011005261451832 04011041821451834 04113390251451835 0498281021451844 0498281031451845 0498383671451847 14456531449473 1447234 1449727 1450207 U06716531450796 U121355681451032 W013009121451017 W023090201450790 W023090201450792 W023090201451018 W033145561451020 W033145591450981 W073441541451026 W073443721451038 W0989693A1451044 W09919661451033 W103727291451039 W113767431451027 W123831761451040 1087165731450953 1449728 U08814851451031 W023143311450980 W073349581451023 W073441541450978 W093590691451029 W09896821451043 01112878341451696 02010398131451698 03010598641451700 03113234941451701 0398164731451828 04011041811451833 0497983621451840 0498281011451842 0498305411451846 0498383681451848 0498489881451849 05011398691451850 05113652481451851 0598352541451854 06011629991451855 06113570991451856 0698693431451866 0698876431451867 0698887841451868 1448769 1448971 1450791 1450793 1451169 1451170 01010209681452418 01010348151452419 01010356271451695 01010356271452380 0197801011452421 0197842261452381 02010398131452382 02010526571452424 02112949751452425 0297938031452427 0298024131452428 0298… (truncated, 138716 characters total — see the official FDA record for the full value)
Recalling firm:
MicroPort Orthopedics Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 3, 2020

DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in preparation for the tibial baseplate keel.

There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.

ALL 50 STATES
▸Full report

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

Recall #:
86257
Lot/product code:
Model/Catalog no. 801-05-040; :Lot/serial No.s 281905L08, 281905L15, 283808L01, 305197L02, 318871L10 Model/Catalog no. 801-05-018, Lot/serial No.s: 215488L08, 236760L01, 228231L01, 241946L02, 259710L01, 314969L01
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.

Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.

ALL 50 STATES
▸Full report

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

Recall #:
85962
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.

Infusion pump component defect may result in interruption of patient monitoring

ALL 50 STATES
▸Full report

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

Recall #:
85997
Lot/product code:
Model: EtCO2 8300; Lot/Serial numbers: 10002682711,  10002720508, 1000287042, 10002882569
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
▸Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 3000162, 300163, 300174, 300176
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
▸Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 353020, 353021, 353023, 353045, 353049
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
▸Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
▸Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 600229, 600230, 600232, 600271, 600282
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 7, 2020

RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044

Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.

CAFLGAINKSMNNYOKPARIVAWA
▸Full report

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

Recall #:
86317
Lot/product code:
Part 509-00-044, Lot 380P1009A , UDI: 00888912144568
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 7, 2020

RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440

Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.

CAFLGAINKSMNNYOKPARIVAWA
▸Full report

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

Recall #:
86317
Lot/product code:
Part 509-00-440, Lot Numbers 387P1042A and 387P1045A, UDI: 00888912144599
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 10, 2020

Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75

Failed Stability Specifications: not meeting quality requirements result for enzyme activity levels noted during routine stability testing.

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-1507-2020
Lot/product code:
Lot #: A9306, Exp 2/28/2022
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
▸Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  00Z2117
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
▸Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A104X T7L042X T8D056X T8L032X T9D044X T0C041X T7L043X T8E053X T8L051X T9D047X T0C042X T7L044X T8E054X T8L104X T9D048X T7F018X T7L045X T8F041X T8L105X T9D049X T7F023X T7L046X T8F042X T8M045X T9D055X T7F024X T7L047X T8F043X T9A007X T9E025X T7J006X T8A005X T8F075X T9A008X T9F051X T7J011X T8A006X T8J011X T9B041X T9H144X T7J012X T8A041X T8K063X T9B042X T9J034X T7K030X T8A042X T8L028X T9C067X T9K078X T7K031X T8C039X T8L029X T9C068X T9K079X T7K032X T8C040X T8L030X T9C146X T9L020X T7K033X T8D055X T8L031X T9C157X T9L034X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
▸Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A013X  T7L050X  T8E048X  T8K051X  T9F118X T0A051X  T7L051X  T8E055X  T8K093X  T9G028X T0A085X  T7L052X  T8E056X  T8L129X  T9G030X T0B025X  T7M021X  T8E061X  T8L130X  T9G038X T0B032X  T7M022X  T8E062X  T8M009X  T9G088X T0B046X  T8A001X  T8E067X  T8M011X  T9G089X T0B047X  T8A002X  T8E068X  T8M097X  T9G090X T0B056X  T8A003X  T8F001X  T9A009X  T9G094X T0B073X  T8A004X  T8F002X  T9A031X  T9G159X T0B081X  T8A045X  T8F026X  T9A056X  T9G160X T0C043X  T8A046X  T8F045X  T9A099X  T9H042X T0C068X  T8A060X  T8F046X  T9B001X  T9H100X T0C069X  T8A061X  T8F047X  T9B004X  T9H101X T0C070X  T8B003X  T8F077X  T9B005X  T9H113X T0C103X  T8B037X  T8H001X  T9B038X  T9H114X T0D054X  T8B038X  T8H002X  T9C007X  T9J030X T0D059X  T8B039X  T8H003X  T9C008X  T9J035X T0D061X  T8B040X  T8H005X  T9C069X  T9J048X T0D115X  T8B041X  T8H006X  T9C070X  T9J073X T0E050X  T8C012X  T8H019X  T9C071X  T9J096X T7F019X  T8C034X  T8H051X  T9C156X  T9J097X T7F021X  T8C035X  T8H052X  T9E030X  T9J098X T7F022X  T8C041X  T8H072X  T9E069X  T9K002X T7J003X  T8C042X  T8J027X  T9E070X  T9K068X T7J004X  T8C044X  T8J038X  T9E071X  T9K104X T7J005X  T8D011X  T8J041X  T9E072X  T9K105X T7J013X  T8D057X  T8J042X  T9E111X  T9L019X T7J020X  T8D058X  T8J058X  T9E119X  T9L074X T7J032X  T8D059X  T8J067X  T9E120X  T9L075X T7L028X  T8D060X  T8K007X  T9F026X  T9L102X T7L029X  T8D061X  T8K009X  T9F049X  T9L103X T7L030X  T8D062X  T8K043X  T9F050X  T9M109X T7L048X  T8E047X  T8K050X  T9F078X  T9M110X T7L049X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)