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Recalls affecting Michigan

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

16,996 recalls found
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Just announced

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

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2021

Trilogy Evo Universal, Product number DS2000X11B

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

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▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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

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

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▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

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

ALL 50 STATES
▸Full report

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

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

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

Defective container: possibility for lack of seal integrity.

ALL 50 STATES
▸Full report

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

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

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

Failed Stability Specifications; not meeting quality requirements for shear.

ALL 50 STATES
▸Full report

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

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

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

Failed Stability Specifications; not meeting quality requirements for shear.

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D

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

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots: 20015114 20015115 20015116 20015117 20015118 20025813 20025814 20025815 20025816 20025817 20025818 20025819 20036187 20036188 20036259 20036260 20036261 20036262 20036327 20036328 20036329 20037133 20046569 20046570 20046615 20046616 20046617 20055967 20055968 20055984 20055985 20055986 20055987 20055988 20055989 20056364 20056365 20056366 20056452 20056453 20056565 20056566 20057064 20075232 20075235 20075616 20075617 20075238 20085525 20085526 20085774 20085775 20086097 20086098 20086099 20086100 20086101 20086102 20086427 20086428 20086429 20095126 20095127 20095128 20095129 20095130 20095131 20095146 20097042 20095147 20095148 20095150 20095151 20096880 20096881 20097041 20097043 20097044 20097045 20097046 20097047 20105605 20105606 20105607 20106571 20106572 20106573 20106677 20106678 20115001 20115002 20115003 20115004 20115005 20115006 20115007 20115008 20115009 20115010 20115011 20115012 20116408 20116409 20116410 20116411 20116815 20116961 20116830 20116831 20116832 20117063 20117064 20125036 20125037 20125245 20125246 20125247 20125248 20125249 20125250 20125454 20125455 20125456 20125457 20125518 20125519 20125520 20125589 20125590 20125591 20125628 20125629 20125630 20125631 20125632 20125633 20125634 20125635 20125636 20125637 20125638 21015733 21015734 21015735 21015736 21015876 21015877 21015737 21015878 21015879 21015989 21015990 21015991 21016007 21016025 21016026 21016056 21016057 21016058 21016232 21016391 21016392 21035751 21035752 21035753 21035757 21035758 21035754 21035755 21035756 21035759 21035760 21045887 21045888 21045889 21045890 21045891 21046137 21046139 21046140 21046574 21046581 21046656 21046673 21046672 21046717
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

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

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

ALL 50 STATES
▸Full report

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

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

BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Buerette Set SmartSite Port (Burette) 3 SmartSite Y-Sites, REF: 10821753; BD Alaris Pump Infusion Buerette Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 11607787; BD Alaris Pump Infusion Buerette Set 0.2Micron Filter Ball Valve SmartSite Port (Burette) 2 SmartSite Y-Sites, REF: 11613191; BD Alaris Pump Infusion Buerette Set Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2440-0600; BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Site, REF: 2441-0007; BD Alaris Pump Infusion Buerette Set Low Sorbing Tubing Smartsite Port (Burette), REF: 2444-0007; BD Alaris Pump Infusion Buerette Set Ball Valve Smartsite Port (Burette) 2 Smartsite Y-Sites, REF: 2447-0007; BD Alaris Pump Infusion Set Back Check Valve 4-Way Stopcock 3 Smartsite Y-Sites Extension Set With SmartSite Port, REF: C24104E

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

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots:  20055717 20066810 20066818 20066819 20077318 20077321 20077322 20077522 20077523 20077541 20086584 20106957 20106958 20106959 21025085 21025086 21025220 20025114 20025123 20026226 20026227 20026322 20026323 20026382 20026383 20026510 20056946 20056947 20057055 20057056 20017423 20096285 20096286 20015347 20016918 20016919 20016960 20016961 20017112 20035102 20035133 20035134 20035281 20035295 20035296 20035368 20035526 20035527 20035603 20035604 20056757 20065191 20065192 20065281 20065282 20065298 20065299 20065346 20065347 20065362 20065759 20065944 20065945 20065946 20075258 20075510 20075511 20075512 20075577 20075643 20075644 20075660 20075719 20075720 20075721 20075887 20075888 20075889 20075890 20076104 20076847 20076848 20076872 20076873 20076874 20076965 20076966 20076967 20076968 20076969 20077074 20077075 20085132 20085133 20085134 20085135 20085697 20085698 20085699 20085729 20085730 20085731 20085858 20085859 20085875 20085876 20086019 20086020 20086036 20086037 20086213 20086214 20086227 20086228 20086229 20086338 20086339 20086353 20086354 20086491 20086924 20086960 20086966 20086965 20087333 20087334 20087341 20087412 20096174 20096183 20096260 20096366 20096400 20096401 20097100 20097101 20097102 20097157 20015346 20056758 20056830 20056850 20056851 20066701 20066724 20066775 20066776 20066777 20105671 20105706 20125218 20125219 21025839 21025840 21025841 20017400 20017401 20036962
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10011087; BD EXTENSION SET SMALLBORE TUBING SmartSite VALVE (DETACHABLE), REF: 10011253; BD EXTENSION SET LOW SORBING TUBING 0.2 MICRON FILTER SmartSite VALVE, REF: 10013902; BD EXTENSION SET 2 SmartSite VALVES Y-CONNECTOR, REF: 10014692; BD EXTENSION SET SMALLBORE TUBING 2 DETACHABLE SmartSite VALVES, REF: 10015488; BD SmartSite NEEDLE FREE VALVE, REF: 2000E; BD Extension Set J-LOOP SMALLBORE Tubing SmartSite VALVE, REF: 20021E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20035E; BD Extension Set SMALLBORE Tubing SmartSite VALVE SLIP LUER, REF: 20037E; BD Extension Set TRI-PORT SMALLBORE Tubing 3 SmartSite VALVES, REF: 20038E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20039E; BD Extension Set SmartSite VALVE SLIP LUER, REF: 20057E; BD Extension Set SmartSite VALVE, REF: 20059E; BD extension Set Y-CONNECTOR 2 SmartSite VALVES, REF: 20061E; BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite VALVES, REF: 20062E; BD EXTENSION SET Y-CONNECTOR 2 SmartSite VALVE, REF: 20159E; BD Extension Set TRI-PORT SMALLBORE TUBING SmartSite VALVE DETACHABLE, REF: 20338E; BD EXTENSION SET SmartSite VALVE, REF: 21059E; BD 8.5-IN PRESSURE RATED EXTENSION SET SmartSite VALVE, REF: 22003E-07; BD Texium SmartSite VALVE MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T; BD EXTENSION SET SmartSite VALVE (DETACHABLE), REF: 22059E; BD EXTENSION SET SmartSite VALVE (DETACHABLE) SLIP LUER, REF: C25015E; BD SmartSite Syringe-Syringe Transfer Device, REF: MV0450

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

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots:  20035964 21016575 20015157 20025207 20025243 20025244 20025245 20025246 20106552 20115468 20115469 21039510 20015758 20055744 20055745 20075637 20075638 20075639 20075673 20096017 20096018 21016323 20125462 20016553 20056551 20076494 20075342 21026223 20075341 21016571 20015128 20015129 20015130 20015131 20015132 20015133 20015134 20015257 20015258 20015259 20015260 20015261 20015908 20015909 20015910 20015911 20016199 20016200 20016201 20016202 20016545 20016546 20016547 20016548 20016549 20016872 20016873 20016874 20016876 20017016 20017017 20017018 20017019 20017077 20017078 20017079 20017080 20017081 20017082 20017432 20017431 20017445 20017446 20017447 20025394 20025395 20025396 20025397 20025398 20025399 20025400 20025401 20025402 20025403 20025537 20025904 20025905 20025906 20025907 20025908 20026416 20026417 20026422 20026612 20026613 20026614 20026615 20026657 20026658 20026655 20026656 20035497 20035498 20035499 20035584 20035585 20035693 20035694 20035695 20035696 20035831 20035832 20035833 20035954 20035974 20035976 20035977 20035978 20035979 20036241 20045312 20045446 20045447 20045448 20045449 20045714 20045715 20045791 20045792 20045793 20045794 20045795 20045796 20045797 20045798 20046047 20046246 20046320 20046321 20046322 20046323 20046324 20046325 20046371 20046372 20046373 20046374 20046539 20046540 20046618 20046619 20046620 20046621 20046645 20046646 20046647 20046648 20046649 20086573 20085924 20085925 20086110 20086111 20087250 20095322 20095323 20095557 20095558 20105992 20106349 20106350 20106351 20106352 20106353 20106354 20106355 20115584 20115585 20115586 20115587 20115589 20115590 20115591 20115592 20115596 20115597 20115599 20115602 20115603 20115604 20115605 20115710 20116994 20116995 20116996 20116997 20116998 20125044 20125045 20125046 20125251 20125252 20125253 20125254 20125639 20125640 20125641 20125642 20125683 20125684 20125685 21016238 21016239 21016240 21025047 21025048 21025046 21025049 21025158 21025284 21025286 21025287 21025288 21025387 21025388 21025389 21035546 21035545 21035547 21035548 21035549 21035550 21035551 21035552 21035553 21035554 21035555 21035556 21035557 21035558 21035559 21035768 21035769 21035770 21035771 21035772 21035773 21035774 21036160 21036161 21036162 21036163 21036164 21036165 21036265 21036266 21036267 21036268 21036269 21036270 21036685 21036708 21036709 21036793 20025613 20035447 20045445 20056567 20075230 20075231 20096525 20096526 20115443 20125734 20125735 20126420 21015632 21015633 21015745 21015746 21026032 21026033 21026034 20016826 20016827 20036929 20056944 20076261 20095884 20115656 20117016 21029597 21029598 21026129 21026130 21026131 20055740 21016395 21016396 20016607 20025053 20025054 20025055 20035897 20045997 20045998 20045999 20046001 20056936 20066144 20066145 20075640 20075946 20075947 20086316 20086446 20095356 20105634 20105635 20105636 20115305 20115437 20117017 20117018 20117019 21015446 21015447 21015534 21015535 21015536 21016268 21016269 21016416 21016417 21016418 21016419 21016420 21026521 21026522 21026523 21026565 21026567 21026608 21026609 21026625 21026626 21026627 21026692 21026712 21026713 21035108 21035109 20015291 20015292 20015389 20015293 20015294 20015295 20015296 20015297 20015298 20015299 20015300 20015301 20015302 20015303 20015487 20015488 20015489 20015490 20015491 20015513 20015514 20015515 20015516 20015517 20015518 20015519 20015520 20015521 20015887 20015892 20015894 20016032 20016033 20016034 20016035 20016036 20016101 20016037 20016102 20016103 20017312 20017313 20017314 20017315 20017316 20025821 20025822 20025823 20025824 20025825 20025826 20025827 20025991 20025820 20025773 20025992 20025993 20025994 20025995 20025996 20025997 20025998 20025999 20026001 20035866 20035865 20035867 20035868 20035869 20035870 20035871 20035872 20035973 20045190 20045191 20045192 20045193 20045308 20045309 20045310 20045311 20045439 20045440 20045441 20045442 20045443 20045444 20045702 20045703 20045704 20045705 20045706 20045707 20045708 20045709 20045710 20045711 20046120 20046121 20046240 20046241 20046242 20046243 20046382 20046383 20046384 20046456 20046457 20046458 20046459 20046460 20046662 20046663 20046672 20046682 20046683 20046684 20046685 20046779 20046780 20046781 20046875 20046876 20055136 20055137 20055138 20055139 20055140 20055141 20055143 20055142 20055144 20055145 20055146 20065646 20065647 20065648 20065851 20065852 20065853 20065854 20065855 20065856 20065857 20065858 20065859 20065860 20065861 20065862 20075405 20075406 20075407 20075408 20075472 20075473 20075474 20075475 20075476 20075477 20075478 20075479 20075480 20075784 20075785 20075786 20075787 20075788 20075789 20075850 20075851 20075852 20075919 20075920 20075923 20076066 20075921 20075922 20076062 20076063 20076064 20076065 20076067 20076068 20076069 20076242 20076243 20076244 20076245 20076796 20076572 20076573 20076797 20076798 20076799 20076800 20076801 20076802 20076803 20076903 20095296 20095297 20095996 2009529… (truncated, 10563 characters total — see the official FDA record for the full value)
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E

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

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
UDI: 27613203013813; Lots: 21045673 21045672 21045671 21045670 21045669 21045243 21036889 21036844 21036767 21036766 21036698 21036697 21036696 21036695 21036643 21036642 21026547 21026546 21026545 21026379 21026378 21026377 21026327 21026326 21026325 21026324 21026323 21025283 21025282 21025281 21025280 21025279 21025278 21025157 21025156 21025155 21016751 21016394 21016393 21015306 21015305 20126555 20126554 20126553 20126552 20126529 20126528 20126527 20126526 20125986 20125985 20125984 20125983 20125982 20125981 20125980 20125979 20125978 20125977 20125976 20125975 20125974 20125973 20125972 20125950 20125949 20125948 20115023 20115022 20115021 20115020 20115019 20115018 20115017 20115016 20115015 20115014 20106570 20106231 20106230 20106229 20105085 20105084 20095138 20095137 20095136 20095135 20095134 20095133 20095132 20066719 20066718 20066717 20066448 20066447 20066446 20066231 20066230 20066229 20066228 20066109 20066108 20066107 20066106 20066105 20066104 20055332 20055331 20055330 20055329 20055080 20055079 20055078 20055077 20055076 20045843 20045842 20045841 20045840 20045839 20045838 20045837 20045836 20035578 20035577 20035496 20035495 20035494 20035493 20025024 20025023 20025022 20025021 20016446 20016445 20016444 20016443 20016442 20016317 20016316 20016315 20016194 20016193 20016192 20016191 20016190 20016105 20016104
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

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

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

ALL 50 STATES
▸Full report

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

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

BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006

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

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots:  20066502 20066503 20066504 20076251 20076352 20086483 20086484 20086485 20086486 20087129 20087130 20096280 20096281 20096282 20096283 20097163 20105074 20105075 20095374 20095375 20096302 20105754 20105755 20105756 20105757 20105758 20115470 21036462 21036463 21036464 21036465 21036466
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006

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

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots:  20066405 20075901 20075902 20076376 20076377 20116469 21016457 21016458 21016459 21016460 21016690 21016691 21035305 21035306 21035418 21035419 21035420 21035421 21035422 21035423 21035424
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006

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

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots:  20025345 20025483 20037040 20037041 20037042 20086605 20086606 20086696 20095927 20096020 20105323 20125599 20125695 20125709 20125710 21015395
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

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

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

ALL 50 STATES
▸Full report

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

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