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Recalls affecting Tennessee

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

17,086 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

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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)

▸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

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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.

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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 November 12, 2021

Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns

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

Recall #:
89129
Lot/product code:
Serial Numbers: As-Maintained System Serial Number 1442 1517 1367 1088 1210 209 422 35 261 692 1468 1469 1470 1471 990 1447 578 579 318 103 1067 518 1022 1513 73 548 549 710 711 107 352 539 319 655 1512 2138 1643 1059 36 1058 1647 1201 884 835 836 1613 769 284 232 1253 1254 1255 427 428 429 618 1203 379 705 708 532 706 707 669 1583 1368 1369 88 84 126 971 218 1696 612 133 1770 458 496 1073 1324 982 1756 351 890 1199 1926 1540 1541 642 433 832 1916 776 664 1545 267 1955 1195 432 632 283 2044 1221 1222 187 188 190 919 1121 34 1491 1320 1187 945 540 1041 1440 1049 1050 1051 1052 1053 1614 425 437 1006 1007 1343 517 1497 80 113 257 303 304 305 306 307 2255 1310 668 673 1760 1797 1798 489 629 750 1060 1337 1338 2059 2094 2095 2104 1336 1335 1178 1692 1693 1694 1695 915 1394 974 975 976 977 613 1448 203 1261 611 1732 1737 375 1466 1467 944 1429 716 324 1963 651 972 702 1799 1869 1870 2063 2062 1134 888 519 33 591 610 1645 1683 1893 211 544 219 2121 411 430 641 643 645 652 928 175 174 256 159 806 328 240 620 1057 520 1188 1025 1027 1083 1103 682 987 1644 993 204 205 340 1675 1808 1809 76 77 568 1125 1126 659 1101 1451 1452 943 1120 1985 1136 179 180 181 182 183 184 464 889 1153 1154 1232 1649 1010 962 445 2036 1004 1516 75 1017 1395 1514 858 927 85 1133 462 523 1628 368 980 1008 1009 1054 584 1979 1980 1309 721 724 94 1319 1119 983 485 916 1342 431 901 1021 1026 722 715 1592 1593 254 286 1347 1578 424 136 137 2180 323 216 1747 89 1856 2099 587 592 1190 1860 2199 1861 1828 134 994 448 1615 833 859 396 337 1312 883 886 1068 1960 1311 237 925 926 936 1749 985 1949 1767 1768 657 1533 189 1928 751 871 872 873 874 1211 236 1911 385 386 924 1416 1534 1097 1098 831 1677 370 405 1558 1671 138 1641 718 719 720 68 58 67 69 71 72 903 350 426 2137 434 435 436 409 404 1733 1100 1684 1260 1262 573 1207 1198 736 1189 885 270 262 961 387 388 367 1314 1194 530 1612 215 986 521 378 1122 1868 1065 513 792 1127 74 569 127 128 129 130 402 704 777 1208 1209 654 272 1239 210 265 2208 666 674 277 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(01)00884838058194(21)1696 (01)00884838058194(21)612 (01)00884838058194(21)133 (01)00884838058194(21)1770 (01)00884838058194(21)458 (01)00884838058194(21)496 (01)00884838058194(21)1073 (01)00884838058194(21)1324 (01)00884838058194(21)982 (01)00884838058194(21)1756 (01)00884838058194(21)351 (01)00884838058194(21)890 (01)00884838058194(21)1199 (01)00884838058194(21)1926 (01)00884838058194(21)1540 (01)00884838058194(21)1541 (01)00884838058194(21)642 (01)00884838058194(21)433 (01)00884838058194(21)832 (01)00884838058194(21)1916 (01)00884838058194(21)776 (01)00884838058194(21)664 (01)00884838058194(21)1545 (01)00884838058194(21)267 (01)00884838058194(21)1955 (01)00884838058194(21)1195 (01)00884838058194(21)432 (01)00884838058194(21)632 (01)00884838058194(21)283 (01)00884838058194(21)2044 (01)00884838058194(21)1221 (01)00884838058194(21)1222 (01)00884838058194(21)187 (01)00884838058194(21)188 (01)00884838058194(21)190 (01)00884838058194(21)919 (01)00884838058194(21)1121 (01)00884838058194(21)34 (01)0088483805819… (truncated, 14274 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 15, 2021

Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45, 0998-UC-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65, 0998-UC-0800-65.

Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.

ALL 50 STATES
▸Full report

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

Recall #:
88983
Lot/product code:
All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-31, 10607567109053; 0998-UC-0800-31, 10607567109053; 0998-00-0800-32, 10607567111117; 0998-UC-0800-32, 10607567111117; 0998-00-0800-33, 10607567109008; 0998-UC-0800-33, 10607567109008; 0998-00-0800-34, 10607567111940; 0998-UC-0800-34, 10607567111940; 0998-00-0800-35, 10607567109107; 0998-UC-0800-35, 10607567109107; 0998-00-0800-36, 10607567114187; 0998-UC-0800-36, 10607567114187; 0998-00-0800-45, 10607567108421; 0998-UC-0800-45, 10607567108421; 0998-00-0800-52, 10607567108438; 0998-UC-0800-52, 10607567108438; 0998-00-0800-53, 10607567108391; 0998-UC-0800-53, 10607567108391; 0998-00-0800-55, 10607567108414; 0998-UC-0800-55, 10607567108414; 0998-00-0800-65, 10607567113432; 0998-UC-0800-65, 10607567113432
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 15, 2021

Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.

Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.

ALL 50 STATES
▸Full report

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

Recall #:
88983
Lot/product code:
All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-75, 10607567112312; 0998-UC-0800-75, 10607567112312; 0998-00-0800-83, 10607567108407; 0998-UC-0800-83, 10607567108407; 0998-00-0800-85, 10607567113449; 0998-UC-0800-85, 10607567113449.
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 16, 2021

Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.

Increase in premature device failures

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

Recall #:
88984
Lot/product code:
Shipped between March 2019 and February 2021.
Recalling firm:
Ohio Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 16, 2021

cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.

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▸Full report

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

Recall #:
89643
Lot/product code:
UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086
Recalling firm:
Roche Molecular Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967

Kit packaging may have small holes compromising product sterility

CACOLAMAMDNDPATNUT
▸Full report

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

Recall #:
89111
Lot/product code:
Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Senior Living Arial Emergency and Nurse Call Systems

Systems are not alarming due to increased memory consumption.

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▸Full report

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

Recall #:
89181
Lot/product code:
Model No. 0900-989; Lot No.: 7VQYZB3, G1GG8B3, 1TX2613, 7VQWZB3, GRRT243, 1TX3613, G1H58B3, HJP7N23, HJP9N23, 51SDR33, and GRRV243; UDI No.: (01)00840948100987(21)7VQYZB3, (01)00840948100987(21)1TX2613, (01)00840948100987(21)7VQZZB3, (01)00840948100987(21)GRRT243, (01)00840948100987(21)G1GF8B3, (01)00840948100987(21)1TX3613, (01)00840948100987(21)G1H58B3, (01)00840948100987(21)HJP7N23, (01)00840948100987(21)HJP9N23, (01)00840948100987(21)51SDR33, (01)00840948100987(21)GRRV243
Recalling firm:
Stanley Security Solutions Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2

Kit packaging may have small holes compromising product sterility

CACOLAMAMDNDPATNUT
▸Full report

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

Recall #:
89111
Lot/product code:
Lot Numbers: 3272267, 3274728, 3323887
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled November 17, 2021

Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64

Temperature Abuse; temperature excursion during shipping

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

Recall #:
D-0286-2022
Lot/product code:
Lot #SAB06761A, exp 04/2023
Recalling firm:
Sandoz Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884

Kit packaging may have small holes compromising product sterility

CACOLAMAMDNDPATNUT
▸Full report

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

Recall #:
89111
Lot/product code:
Lot Numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1

Kit packaging may have small holes compromising product sterility

CACOLAMAMDNDPATNUT
▸Full report

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

Recall #:
89111
Lot/product code:
Lot Numbers: 3289074
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3

Kit packaging may have small holes compromising product sterility

CACOLAMAMDNDPATNUT
▸Full report

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

Recall #:
89111
Lot/product code:
Lot Numbers: 3347921, 3358240
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2

Kit packaging may have small holes compromising product sterility

CACOLAMAMDNDPATNUT
▸Full report

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

Recall #:
89111
Lot/product code:
Lot Numbers: 3309015, 3347920, 3351630, 3356836, 3360219, 3364419
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2021

Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000

(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results

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

Recall #:
89160
Lot/product code:
Software version: V1.25.1 and lower. UDI: 00630414002163
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2021

SOMATOM Definition AS-Computed tomography system Model 8098027

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

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

Recall #:
89208
Lot/product code:
Serial Numbers: 96278 96887 66027 64492 64541 64519 64427 67297 95303 96267 64864 96211 59802 67241 64798 98423 65597 95389 96689 64419 64347 64860 64382 64869 65238 66734 92078 95804 96471 98402 95985 96710 95889 95778 92353 95847 95936 67236 64464 64471 65852 95798 96454 96466 95363 64927 91966 98354 95934 96279 95807 95602 95639 65288 64773 95229 65297 65159 64036 95628 66143 64317 95610 98474 95859 95939 95601 95070 95882 95596 95791 66219 65752 98356 95677 64104 66506 66312 95844 95670 66858 65382 98424 66588 92280 67399 64413 64559 64235 66611 92056 92261 92342 95684 66319 95545 96547 95702 95766 67218 67128 64859 95788 64487 96491 65370 95234 95466 95809 67098 95616 59819 66032 95372 95461 95043 66087 95582 95143 67363 96950 65768 92186 96941 95951 95100 98422 98413 66600 64030 66844 66649 66635 95299 66225 66842 66916 95584 95151 66188 66355 64022 92375 95578 96777 66467 98417 64498 64763 64372 95362 65788 65015 66150 96647 66933 96472 98366 65299 66461 66604 65115 66441 96948 95196 92184 92131 65515 66498 96380 96973 66197 66688 66164 95777 65769 95609 96424 96020 66768 65304 67233 95742 92298 64825 96413 96015 96824 65770 59825 67310 64066 66201 66406 66574 96529 95856 96544 65713 66700 65926 66503 98404 65443 96305 95881 95845 98364 96845 65804 95280 96773 96455 66126 65478 95923 95903 96747 67116 96726 95095 96370 98445 95940 64516 95784 98403 65407 65251 64720 92335 92300 66969 96750 96530 64685 66001 96038 96863 96992 95175 95457 95459 66928 65403 96341 66542 95465 92358 96984 67175 65740 66690 95451 67326 95274 95875 95983 67380 65555 64709 65291 66965 66151 67181 95891 64314 95181 66557 96633 96543 96669 66148 96335 95892 67288 67085 64446 92180 66705 96823 65418 95152 96421 67133 67048 95411 64677 67319 95960 64740 59820 98441 65755 66019 66062 92023 96014 96865 65501 66234 64221 98449 98357 95893 65927 65186 95659 59803 95193 98363 96709 96351 95413 64211 96385 95848 98359 96785 156012 66478 66850 96443 96749 92053 95437 96346 95272 64218 95207 64480 64947 95393 96893 96438 66999 95846 64463 65283 96369 95485 64835 64913 64834 64942 96316 96028 92243 66011 95647 67391 96812 66297 65818 96418 95344 92321 66618 96288 66396 96238 95080 96676 92101 96352 96444 92313 92177 96271 66473 66423 66304 66349 67010 67108 95438 95439 95751 95710 96336 96324 67229 65611 67126 65936 66958 65709 65556 92033 92296 96312 95906 96896 96021 92254 65735 95768 95715 91964 64489 64732 92169 98401 66183 65793 96937 95928 95968 98447 64051 95014 65728 96832 64282 95174 64031 66587 66789 64056 95425 67291 95415 64729 65235 64999 98411 66232 98350 66290 65229 96226 92132 65925 65148 95818 64060 95661 65455 64960 96340 66173 65145 64110 96929 66918 66808 96697 66843 92347 92307 65844 95339 95022 95748 95199 65779 96553 96303 65272 95646 95034 66021 66095 99401 96022 65151 96828 67312 96338 95302 64568 59828 65610 64248 96023 67169 67193 96545 64602 64707 66237 64096 98353 95952 65079 65831 92087 95868 96991 96942 92336 96899 64501 66308 95378 96266 65003 66792 95737 67274 96922 95912 65808 92207 92125 95361 65800 95961 95701 95376 96328 65557 65371 92315 66356 66381 96713 66821 95580 66812 64572 64967 65022 64052 65795 66221 67036 95427 65173 64407 65848 66930 66077 95782 95938 67251 95972 66116 95192 96851 65586 96250 96776 96347 96310 92058 64998 66457 66502 65154 66490 92088 95785 92099 92288 95522 64238 66110 59823 59829 64094 65659 66248 98473 66579 64796 64500 96425 95493 96061 96861 95593 64983 66931 66288 59824 98442 59822 96736 98414 95678 64247 66529 96541 92113 64322 95342 96983 64148 65760 65865 66265 66335 65854 95786 96524 65017 66813 96925 96909 98352 59812 96589 96440 98409 95592 66081 64924 64934 65701 66082 65909 64813 59814 96677 95221 95703 92108 65347 65392 92091 66925 95087 96717 92176 95517 98362 67232 96821 66076 66536 66041 64019 64767 66689 95441 66407 96857 95947 95484 65493 95521 95059 95359 65365 65803 65956 96837 64160 64605 64064 95021 95013 66023 95499 96967 64675 92189 96538 96668 66510 95924 95498 95147 98452 95808 66403 92409 91968 92000 66470 65680 65805 95575 96049 96040 95591 92323 66223 66540 96268 59815 67192 66630 95719 66280 95079 64908 65247 92057 95632 92208 92155 92165 96542 96740 66859 64297 95559 65995 67321 95797 95758 95145 96864 96281 66664 65667 96058 65157 96463 95440 95549 66434 66017 95577 96302 95523 66445 95674 65773 67083 156018 95642 95717 91996 92164 96053 66677 95520 96956 96011 95937 91974 66462 96327 96326 95402 96645 95025 96286 96700 96029 66882 91990 96604 95024 64196 65906 95927 96364 96397 67392 95886 65829 64712 64132 92045 65866 65743 65830 65694 65303 95195 92069 95640 98421 67167 95510 66771 95635 96695 65777 66860 66694 96062 65368 92098 95914 95657 65758 95513 66425 96275 96003 95529 98418 98419 64785 95716 65998 66447 65652 66959 UDI: UDI 04056869003665
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2021

SOMATOM Confidence -Computed tomography systems Model 10590100

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

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

Recall #:
89208
Lot/product code:
Serial Numbers: 100172 100091 100112 100362 100278 100158 100143 100129 100237 100238 100191 100356 100425 100216 100307 100325 100328 100329 100326 100239 100461 100213 100070 100062 100072 100022 100107 100241 100157 100055 100340 100347 100137 100267 100190 100252 100438 100046 100197 100092 100202 100313 100311 100043 100136 100189 100283 100156 100079 100049 100056 100147 100262 100018 100240 100117 100097 100274 100242 100099 100383 100059 100289 100312 100174 100073 100016 100182 100146 100058 100170 100175 100292 100090 100271 100463 100257 100273 100067 100160 100218 100367 100087 100309 100284 100207 100405 100261 100025 100338 100272 100053 100019 100421 100280 100357 100220 100214 100393 100394 100486 100140 100085 100279 100254 100353 100298 100379 UDI: UDI 04056869011011
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2021

SOMATOM Edge Plus-Computed tomography system Model 1026700

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

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

Recall #:
89208
Lot/product code:
Serial Numbers: 122022 122185 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122194 122141 122167 122156 122183 122081 122126 122129 122090 122130 122179 122089 122085 122037 122009 122163 122177 122066 122064 122038 122161 122132 122171 122153 122168 122158 122144 122063 122086 122035 122041 122112 122114 122107 122101 122108 122109 122162 122187 122174 122125 122178 122011 122182 122052 122034 122057 122145 122147 122050 122106 122189 122180 122061 122051 122166 122170 122092 122004 UDI: UDI 04056869006949
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2021

Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.

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

Recall #:
89098
Lot/product code:
Kit Product Code MOL1455 (UDI 01-30816101025092) contains 3 discs with Disc Product Code MOL1452. Below lists the MOL1455 Kit Lot numbers (and MOL1452 Disc Lot Numbers):  12410N (12152N), 12411N (12147N), 12413N (12149N), 12477N (12150N), 12602N (11548NA), 12603N (12144N), 12721N (12148N), 12889N (12151N), 13369N (12817N), 13370N (13151N), 13434N (12382N), 13652N (12835N), and 13242N (12154N)*.  *Kit Lot #13242N (Disc Lot #12154N) was shipped to Europe and not within the US.
Recalling firm:
DiaSorin Molecular LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2021

SOMATOM Definition Edge -Computed tomography system Model 10590000

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

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▸Full report

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

Recall #:
89208
Lot/product code:
Serial Numbers: 155403 84012 83047 83095 83915 83801 155351 155658 155353 83826 83754 83277 83249 83904 155521 83632 83743 155578 83931 83979 155393 155396 155413 155489 83238 83336 83984 83401 84006 83834 155671 155649 83562 155341 83564 155613 83582 155606 83596 155596 155485 155437 83934 83746 83234 83971 155573 155335 83321 155422 83332 155459 155382 83994 83026 83330 155501 155639 155535 83281 83558 83767 155600 83880 83683 155360 155361 155564 83339 155580 83244 155615 83585 83899 155504 155315 155592 83613 83852 83226 83271 83607 84011 155405 83403 83599 155373 83695 83937 83246 83388 83668 155642 155343 155554 155399 83584 83837 83591 155616 83878 83714 155463 155447 155630 83574 155318 83567 83832 83886 83662 83763 83308 155312 155557 83871 83375 83988 155629 155637 83227 83359 83031 155364 83520 83262 155502 155627 84019 83903 83901 155524 84024 155513 83798 83292 83243 83319 83294 83544 83637 83640 83705 83083 83096 83707 155354 155507 83581 83717 155634 155632 83728 83056 83950 155559 83382 83819 83041 83363 83307 155388 84020 83732 83752 155581 155584 155569 155427 83961 155329 83845 83236 83348 155374 155365 83846 83399 155601 83749 83847 155322 83786 155300 155636 83975 84016 155389 83914 83842 83775 83084 83004 155358 155623 83669 155443 155304 83014 83573 155655 155515 83796 83274 94801 83768 155575 83684 83552 83210 84001 83537 83233 83352 83569 83909 155532 83968 155348 155585 83711 83697 155572 83991 155668 83395 155356 155357 155660 155442 155582 155342 155530 83621 83859 83335 83278 83742 83018 83322 83392 155558 155350 83279 83276 83365 83970 83928 83015 83093 83327 83091 83946 83207 83938 155316 83230 83254 83680 83708 83945 155594 155621 155605 83291 155549 155328 83203 83214 83913 83896 155583 155614 83790 83875 155553 83232 83362 83824 83306 83542 84010 155384 155448 155506 155412 155493 83942 83941 84017 83981 155566 83257 155576 155495 83057 83539 83810 155579 83758 155497 83239 83398 83565 83313 83653 83957 83347 83349 84027 83323 83739 155369 83266 155510 83522 83898 83951 83387 155400 83733 155407 155371 155638 83823 155434 155309 155653 155386 155570 83611 83633 83985 155380 83967 83589 UDI: UDI 04056869006949
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled November 19, 2021

AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2

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

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

Recall #:
D-0266-2022
Lot/product code:
Black capped bottles have no lot numbers but include expiration dates of 5/21/2022 and 05/24/2022. Clear capped bottles have neither lot numbers nor expiration dates.
Recalling firm:
American Screening LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2021

QIAcube Connect MDx, Model No. 9003070

During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.

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

Recall #:
90758
Lot/product code:
UDI-DI (GTIN): 04053228039129 Serial Numbers (U.S.) 30000 30009 30027 30039 30049 30061 30073 30002 30010 30028 30041 30050 30062 30075 30003 30132 30031 30042 30051 30063 30078 30004 30013 30032 30043 30053 30064 30080 30005 30016 30034 30044 30057 30065 30082 30006 30019 30035 30045 30058 30067 30089 30007 30021 30033 30046 30059 30069 30090 30008 30023 30037 30047 30060 30071 30093 30094 30095 30097 30102 30104 30109 30112 30114 30115 30117 30118 30119 30121 30124 30127 30128 30129 30130 30131 30133 30134 30136 30138 30139 30140 30141 30143 30145 30106 30025 30077 30054 30055 30066 30076
Recalling firm:
Qiagen Sciences LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2021

VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

Lower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.

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

Recall #:
89183
Lot/product code:
Lot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898)
Recalling firm:
Ortho-Clinical Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 23, 2021

1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.

Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.

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

Recall #:
89199
Lot/product code:
1. Sensis- 10764561; UDI: 04056869010137; Serial Numbers: 103493, 103432, 103466 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199; Serial Numbers: 103137, 103144, 103453, 103108, 103111, 103047, 103048, 103171, 103182, 103193, 103301, 103170, 103223,, 103225, 103247, 103313, 103315, 103196, 103198, 103166, 103173, 103177, 103184, 103186, 103199, 102326, 103139, 103161, 103167, 103168, 103172, 103178, 100263, 103424, 103319, 103320, 103321, 103323, 103325, 103328, 103330, 103333, 103334, 103335, 103344, 100216, 103337, 100416, 102008, 103413, 101083, 100208, 100209, 102138, 102145, 102147, 103160, 103314, 102199, 103079, 102221, 103123, 103124, 103131, 100163, 100306, 100309, 103300, 101099, 101100, 101101, 103265, 100422, 103019, 103331, 103362, 103393, 103402, 103419, 103252, 103261, 103267, 103269, 103270, 103276, 103277, 103280, 103281, 103022, 103381, 103194 103145, 103148, 103152, 100345, 102183, 103345, 103368, 103415, 103416, 103245, 103249, 103250, 103264, 103080, 103082, 103086, 103088, 103089, 103090, 100231, 103431, 103306, 103341, 103114, 100070, 100071, 100074, 102155, 102157, 103040, 103042, 103039, 102174, 102182, 103130, 103200, 103234, 103116, 103117, 103119, 103288, 103008, 103216, 103465, 103189, 103208, 102010, 102295, 102296, 102302, 100006, 100005, 103352, 103283, 103308, 103310, 103115, 103244, 103246, 103014, 103242, 102143, 103359, 103274, 103437 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205; Serial Numbers: 123021, 123004, 123047, 123053, 122011 ***Updated 1/18/22*** SENSIS Vibe Hemo, Serial #103185 ***Updated 2/24/22*** SENSIS Vibe Hemo Serial #103290 103510 103451 103461 103444 103450 103448 103445 103442 103449 103439 103457 SENSIS Vibe Combo Serial #123055 123056 123058 The following serial numbers have been removed from the scope of this recall: SENSIS Vibe Hemo Serial #103301 103424 ***Updated 8/5/22*** The following serial numbers have been added to the recall: SENSIS Vibe Combo Serial numbers 103307, 103312
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2021

Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722033, 722034, 722036, 722038, 722039. Allura Xper F010 {C+F). 722003 Allura Xper F010/10 722005 Allura Xper F020 722006 Allura Xper F020/10 and F020/20 722008 Allura Xper F010 722010 Altura Xper F010/10 722011 Allura Xper F020 722012 Allura Xper FD20 biplane 722013 Allura Xper FDlO OR Table 722014 Allura Xper FD20 OR Table 722015 Allura Xper FDl0/10 OR Table 722019 Allura Xper FD20 Biplane OR Table 722020 Allura Xper FD10 OR Table 722022 Allura Xper FD20 OR Table 722023 Allura Xper FD10/10 OR Table 722024 Altura Xper FD20 Biplane OR Table 722025 Allura Xper FD10 722026 Allura Xper FD10/10 722027 Altura Xper FD20/10 biplane 722029 Allura Xper FD10 OR Table 722033 Allura Xper FD10/10 OR Table 722034 Allura Xper FD20/10 OR Table 722036 Allure Xper F020/20 722038 Altura Xper FD20/20 biplane OR Table 722039

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

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

Recall #:
89375
Lot/product code:
Allura Xper FD10 722003/722026  (US) S/N:  24 40 71 162 191 266 283 294 319 347 406 485 825 959 965 967 985 990 1246 1353 1444 1944 1949 UDI: (01)00884838054189(21)825 (01)00884838054189(21)967 (01)00884838054189(21)1246 (01)00884838054189(21)965 (01)00884838054189(21)959 (01)00884838054189(21)990 (01)00884838054189(21)985   Allura Xper FD10/10 722005 S/N: 144 US OUS: 37 52 74 79 80 108 279 417 459  Allura Xper FD20 722006 S/N: US 44 72 234 246 263 268 327 333 429 469 471 498 514 535 550 554 588 604 718 754 766 861 1174 1274 1355 1400 1783 1831 1844 1878 1886 1931 2018 UDI: (01)00884838054202(21)893  OUS: 11 40 89 102 112 125 151 244 364 408 431 484 568 580 594 597 602 640 643 704 811 940 971 1262 1312 1402 1405 1424 1465 1481 1658 1691 1794 1796 1815 1852 1859 1879 1891 1948 1959 1974 1985 1988 2141 2311 2521 2554   Allura Xper FD20 Biplane 722008 S/N: 33, 82, 374 (US) OUS: 39 86 224 249 336 384 388 532   Allura Xper FD10 722010 S/N:OUS 163 340 1422 1429 1434  Allura Xper FD20 722012 S/N: OUS 395 463 927 1013 1518 2652 2854 2918  Allura Xper FD20 OR Table 722015 S/N: 30 (OUS)  Allura Xper FD10 722026 S/N OUS: 315 701 748 884 888 943 948 960 971 975 978 984 989 995  Allura Xper FD10/10 722027 S/N: OUS 268 278  Allura Xper FD20/10 722029 S/N:OUS 9  Allura Xper FD10 722026 S/N : US 825 959 965 967 985 990 1246  OUS: 11 40 89 102 112 125 151 244 364 408 431 484 568 580 594 597 602 640 643 704 811 940 971 1262 1312 1402 1405 1424 1465 1481 1658 1691 1794 1796 1815 1852 1859 1879 1891 1948 1959 1974 1985 1988 2141 2311 2521 2554  Allura Xper FD10/10 266 722027 S/N: 266  Allura Xper FD20 722028 S/N: 893 UDI: (01)00884838054202(21)893  Allura Xper FD20/10 722029 S/N: 91, 94 US UDI: (01)00884838054219(21)94 OUS:  S/N:6
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2021

Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

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▸Full report

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

Recall #:
89375
Lot/product code:
S/N: OUS 109
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)