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Recalls affecting Vermont

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

16,288 recalls found

Just announced

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

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

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled 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.

ALL 50 STATES
Full report

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.

ALL 50 STATES
Full report

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.

ALL 50 STATES
Full report

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.

ALL 50 STATES
Full report

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.

ALL 50 STATES
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)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2021

DBB-06 Hemodialysis Delivery System

Device lacks premarket approval.

ALL 50 STATES
Full report

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

Recall #:
88641
Lot/product code:
Model Number: DBB-06; Serial Numbers: J1910861, J1905670, J1905916, J1910971, J1909943, J1909306, J1908111, J1909202, J1907127, J1908023, J1910962, J1910866, J1910028, J1909307, J1907329, J1909853, J1908776, J1908108, J1914585, J1908762, J1909020, J1908872, J1908439, J1908777, J1910867, J1911026, J1907034, J1911033, J1908665, J1909209, J1909705, J1906923, J1911029, J1910870, J1910967, J1911040, J1910499, J1905788, J1910558, J1909689, J1910498, J1909315, J1909662, J1906052, J1910692, J1909412, J1908116, J1910688, J1908582, J1908657, J1909017, J1908281, J1908581, J1909012, J1908660, J1907321, J1907123, J1907317, J1911036, J1905580, J1911354, J1911217, J1907939, J1911035, J1908584, J1911039, J1906050, J1910494, J1909850, J1910560, J1908020, J1908115, J1907932, J1908118, J1910774, J1905789, J1905576, J1909116, J1910489, J1909312, J1908435, J1905791, J1905921, J1910116, J1910027, J1909407, J1909406, J1910491, J1909405, J1909952, J1910495, J1910023, J1909947, J1909945, J1909690, J1910296, J1910300, J1910112, J1910030, J1909414, J1909308, J1909942, J1909313, J1910118, J1905793, J1910690, J1905920, J1910686, J1910400, J1911038, J1910297, J1910115, J1910406, J1905927, J1910136, J1908417, J1908778, J1908034, J1907320, J1909122, J1908114, J1907116, J1908664, J1906921, J1908112, J1908870, J1908757, J1908120, J1908570, J1908291, J1907937, J1908441, J1908583, J1908658, J1908024, J1909022, J1908030, J1908770, J1909204, J1908285, J1907931, J1910862, J1908866, J1908426, J1908774, J1908033, J1908113, J1908750, J1906826, J1907119, J1909021, J1907122, J1908773, J1908659, J1908771, J1909200, J1909199, J1908779, J1909011, J1908571, J1909117, J1906927, J1910860, J1911223, J1911352, J1905787, J1905926, J1910969, J1909708, J1905799, J1911220, J1910562, J1910864, J1908025, J1907926, J1909109, J1909119, J1908751, J1908412, J1907106, J1909024, J1907033, J1908662, J1911115, J1914588, J1911222, J1905800, J1910857, J1910488, J1905795, J1905919, J1908752, J1910402, J1914584, J1905667, J1910869, J1908424, J1905918, J1905575, J1905798, J1908760, J1905579, J1910685, J1910691, J1911114, J1905923, J1908572, J1905922, J1905578, J1905581, J1905928, J1911027, J1911216, J1905584, J1911221, J1905666, J1911218, J1910868, J1905660, J1905582, J1905674, J1910687, J1908022, J1909208, J1909120, J1908107, J1910856, J1910779, J1910564, J1910863, J1905577, J1905930, J1909110, J1905801, J1908109, J1908768, J1911219, J1910694, J1906055, J1908772, J1914587, J1906053, J1911357, J1909304, J1908871, J1908663, J1908289, J1907126, J1908661, J1908294, J1908575, J1908769, J1905668, J1909305, J1909196, J1908578, J1909197, J1909195, J1908754, J1908117, J1909015, J1908026, J1909013, J1907105, J1906825, J1909112, J1908758, J1909206, J1910563, J1910775, J1909121, J1909203, J1907453, J1909111, J1907328, J1908867, J1908414, J1908775, J1911350, J1908761, J1909114, J1907928, J1907933, J1908416, J1908428, J1908437, J1908865, J1909019, J1909123, J1906926, J1907936, J1908749, J1908763, J1909115, J1909118, J1908110, J1908421, J1908580, J1908874, J1909207, J1908579, J1909302, J1908415, J1908873, J1907109, J1907318, J1907454, J1907927, J1907929, J1908021, J1908119, J1908280, J1908282, J1908423, J1908429, J1908442, J1908577, J1908651, J1908753, J1908759, J1909010, J1907128, J1907935, J1908031, J1908780, J1909014, J1906827, J1906830, J1907930, J1906829, J1906924, J1906925, J1906930, J1907029, J1907035, J1907037, J1907315, J1907324, J1907925, J1907938, J1908027, J1908028, J1908029, J1908032, J1908290, J1908419, J1908420, J1908430, J1908433, J1908436, J1908438, J1908440, J1908574, J1908576, J1908655, J1908781, J1908868, J1909016, J1909018, J1909023, J1909113, J1909198, J1906831, J1906834, J1907038, J1907117, J1907118, J1907124, J1908283, J1908284, J1908286, J1908413, J1908425, J1908432, J1908434, J1908652, J1908869, J1907125, J1908293, J1908418, J1908431, J1908573, J1908654, J1907326, J1908422, J1908653, J1907120, J1907325, J1908292, J1906838, J1906118, J1906400, J1906784, J1906824, J1906828, J1906835, J1906836, J1906928, J1906108, J1906121, J1906291, J1906404, J1906779, J1906780, J1906781, J1906782, J1906110, J1906113, J1906832, J1906931, J1906932, J1906933, J1906411, J1906109, J1906117, J1906282, J1906287, J1906405, J1906407, J1906409, J1906281, J1906286, J1906289, J1906292, J1906293, J1906294, J1906408, J1906116, J1906280, J1906283, J1906403, J1906783, J1907114, J1906929, J1907031, J1907032, J1907036, J1907115, J1907455, J1906833, J1906920, J1906934, J1907108, J1907322, J1907323, J1906107, J1906837, J1906922, J1907030, J1907121, J1907319, J1906778, J1906511, J1906663, J1906664, J1906667, J1906668, J1906669, J1906671, J1906672, J1906673, J1906675, J1906677, J1907458, J1907459, J1907460, J1907463, J1907464, J1907465, J1907466, J1907624, J1907625, J1907628, J1907630, J1907631, J1907633, J1907636, J1907637, J1907711, J1907712, J1907713, J1907714, J1907715, J1907716, J1907717, J1907719, J1907720, J1907722, J1907723, J1906410, J1906509, J1906510, J1906666, J1906670, J1906674, J1906770, J1… (truncated, 7846 characters total — see the official FDA record for the full value)
Recalling firm:
Nikkiso Ltd - Shizuoka Plant
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2021

Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109

Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation

ALL 50 STATES
Full report

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

Recall #:
89190
Lot/product code:
Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2021

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89173
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Heel Snuggler, Reference # 989805603411 99047

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Infant Heel Warmers w/strap, Reference # 989805603201 1223

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Medichoice Infant Heel Warmer, Reference # 989805643721 1079906

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 30, 2021

Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.

Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.

Full report

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

Recall #:
89070
Lot/product code:
Activforce Kit Number: AB0000-AC5540 Serial Numbers: 5P1011011708AB0000 5P1011011708AB0001 5P1011011708AB0002 5P1011011708AB0003 5P1011011708AB0004 5P1011011708AB0005 5P1011011708AB0006 5P1011011708AB0007 5P1011011708AB0008 5P1011011708AB0009 5P1011011708AB0010 5P1011011708AB0011 5P1011011708AB0012 5P1011011708AB0013 5P1011011708AB0014 5P1011011708AB0015 5P1011011708AB0016 5P1011011708AB0017 5P1011011708AB0018 5P1011011708AB0019 5P1011011708AB0020 5P1011011708AB0021 5P1011011708AB0022 5P1011011708AB0023 5P1011011708AB0024 5P1011011708AB0025 5P1011011708AB0026 5P1011011708AB0027 5P1011011708AB0028 5P1011011708AB0029 5P1011011708AB0030 5P1011011708AB0031 5P1011011708AB0032 5P1011011708AB0033 5P1011011708AB0034 5P1011011708AB0035 5P1011011708AB0036 5P1011011708AB0037 5P1011011708AB0038 5P1011011708AB0039 5P1011011708AB0040 5P1011011708AB0041 5P1011011708AB0042 5P1011011708AB0043 5P1011011708AB0044 5P1011011708AB0045 5P1011011708AB0046 5P1011011708AB0047 5P1011011708AB0048 5P1011011708AB0049 5P1011011708AB0050 5P1011011708AB0051 5P1011011708AB0052 5P1011011708AB0053 5P1011011708AB0054 5P1011011708AB0055 5P1011011708AB0056 5P1011011708AB0057 5P1011011708AB0058 5P1011011708AB0059 5P1011011708AB0060 5P1011011708AB0061 5P1011011708AB0062 5P1011011708AB0063 5P1011011708AB0064 5P1011011708AB0065 5P1011011708AB0066 5P1011011708AB0067 5P1011011708AB0068 5P1011011708AB0069 5P1011011708AB0070 5P1011011708AB0071 5P1011011708AB0072 5P1011011708AB0073 5P1011011708AB0074 5P1011011708AB0075 5P1011011708AB0076 5P1011011708AB0077 5P1011011708AB0078 5P1011011708AB0079 5P1011011708AB0080 5P1011011708AB0081 5P1011011708AB0082 5P1011011708AB0083 5P1011011708AB0084 5P1011011708AB0085 5P1011011708AB0086 5P1011011708AB0087 5P1011011708AB0088 5P1011011708AB0089 5P1011011708AB0090 5P1011011708AB0091 5P1011011708AB0092 5P1011011708AB0093 5P1011011708AB0094 5P1011011708AB0095 5P1011011708AB0096 5P1011011708AB0097 5P1011011708AB0098 5P1011011708AB0099 5P1011011708AB0100 5P1011011708AB0101 5P1011011708AB0102 5P1011011708AB0103 5P1011011708AB0104 5P1011011708AB0105 5P1011011708AB0106 5P1011011708AB0107 5P1011011708AB0108 5P1011011708AB0109 5P1011011708AB0110 5P1011011708AB0111 5P1011011708AB0112 5P1011011708AB0113 5P1011011708AB0114 5P1011011708AB0115 5P1011011708AB0116 5P1011011708AB0117 5P1011011708AB0118 5P1011011708AB0119 5P1011011708AB0120 5P1011011708AB0121 5P1011011708AB0122 5P1011011708AB0123 5P1011011708AB0124 5P1011011708AB0125 5P1011011708AB0126 5P1011011708AB0127 5P1011011708AB0128 5P1011011708AB0129 5P1011011708AB0130 5P1011011708AB0131 5P1011011708AB0132 5P1011011708AB0133 5P1011011708AB0134 5P1011011708AB0135 5P1011011708AB0136 5P1011011708AB0137 5P1011011708AB0138 5P1011011708AB0139 5P1011011708AB0140 5P1011011708AB0141 5P1011011708AB0142 5P1011011708AB0143 5P1011011708AB0144 5P1011011708AB0145 5P1011011708AB0146 5P1011011708AB0147 5P1011011708AB0148 5P1011011708AB0149 5P1011011708AB0150 5P1011011708AB0151 5P1011011708AB0152 5P1011011708AB0153 5P1011011708AB0154 5P1011011708AB0155 5P1011011708AB0156 5P1011011708AB0157 5P1011011708AB0158 5P1011011708AB0159 5P1011011708AB0160 5P1011011708AB0161 5P1011011708AB0162 5P1011011708AB0163 5P1011011708AB0164 5P1011011708AB0165 5P1011011708AB0166 5P1011011708AB0167 5P1011011708AB0168 5P1011011708AB0169 5P1011011708AB0170 5P1011011708AB0171 5P1011011708AB0172 5P1011011708AB0173 5P1011011708AB0174 5P1011011708AB0175 5P1011011708AB0176 5P1011011708AB0177 5P1011011708AB0178 5P1011011708AB0179 5P1011011708AB0180 5P1011011708AB0181 5P1011011708AB0182 5P1011011708AB0183 5P1011011708AB0184 5P1011011708AB0185 5P1011011708AB0186 5P1011011708AB0187 5P1011011708AB0188 5P1011011708AB0189 5P1011011708AB0190 5P1011011708AB0191 5P1011011708AB0192 5P1011011708AB0193 5P1011011708AB0194 5P1011011708AB0195 5P1011011708AB0196 5P1011011708AB0197 5P1011011708AB0198 5P1011011708AB0199 5P1011011708AB0200 5P1011011708AB0201 5P1011011708AB0202 5P1011011708AB0203 5P1011011708AB0204 5P1011011708AB0205 5P1011011708AB0206 5P1011011708AB0207 5P1011011708AB0208 5P1011011708AB0209 5P1011011708AB0210 5P1011011708AB0211 5P1011011708AB0212 5P1011011708AB0213 5P1011011708AB0214 5P1011011708AB0215 5P1011011708AB0216 5P1011011708AB0217 5P1011011708AB0218 5P1011011708AB0219 5P1011011708AB0220 5P1011011708AB0221 5P1011011708AB0222 5P1011011708AB0223 5P1011011708AB0224 5P1011011708AB0225 5P1011011708AB0226 5P1011011708AB0227 5P1011011708AB0228 5P1011011708AB0229 5P1011011708AB0230 5P1011011708AB0231 5P1011011708AB0232 5P1011011708AB0233 5P1011011708AB0234 5P1011011708AB0235 5P1011011708AB0236 5P1011011708AB0237 5P1011011708AB0238 5P1011011708AB0239 5P1011011708AB0240 5P1011011708AB0241 5P1011011708AB0242 5P1011011708AB0243 5P1011011708AB0244 5P1011011708AB0245 5P1011011708AB0246 5P1011011708AB0247 5P1011011708AB0248 5P1011011708AB0249 5P1011011708AB0250 5P1011011708AB0251 5P1011011708AB0252 5P1011011708AB0253 5P1011011708AB0254 5P1011011708AB0255 5P1011011708AB0256 5P1011011708AB0257 5P1011011708AB0258 5P1011011708AB0259 5P10110… (truncated, 295331 characters total — see the official FDA record for the full value)
Recalling firm:
Activbody, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 30, 2021

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64

Stronger than it should be Drug: Minimally stronger than it should be

ALL 50 STATES
Full report

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

Recall #:
D-0296-2022
Lot/product code:
Lot #: 15594, Exp Date 05/2023
Recalling firm:
Teligent Pharma, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 30, 2021

activforce 2 package labeling: Model: Activ5-M R 201-200563

Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.

Full report

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

Recall #:
89070
Lot/product code:
Activforce 2 Serial Numbers: 5M1011012046AK7655 5M1011012046AK7556 5M1011012046AK7557 5M1011012046AK7559 5M1011012046AK7560 5M1011012046AK7561 5M1011012046AK7562 5M1011012046AK7563 5M1011012046AK7564 5M1011012046AK7565 5M1011012046AK7566 5M1011012046AK7567 5M1011012046AK7568 5M1011012046AK7569 5M1011012046AK7570 5M1011012046AK7571 5M1011012046AK7572 5M1011012046AK7573 5M1011012046AK7574 5M1011012046AK7575 5M1011012046AK7576 5M1011012046AK7577 5M1011012046AK7578 5M1011012046AK7579 5M1011012046AK7580 5M1011012046AK7581 5M1011012046AK7582 5M1011012046AK7583 5M1011012046AK7584 5M1011012046AK7585 5M1011012046AK7586 5M1011012046AK7587 5M1011012046AK7588 5M1011012046AK7589 5M1011012046AK7590 5M1011012046AK7591 5M1011012046AK7592 5M1011012046AK7593 5M1011012046AK7594 5M1011012046AK7595 5M1011012046AK7596 5M1011012046AK7597 5M1011012046AK7598 5M1011012046AK7599 5M1011012046AK7600 5M1011012046AK7601 5M1011012046AK7602 5M1011012046AK7603 5M1011012046AK7604 5M1011012046AK7605 5M1011012046AK7606 5M1011012046AK7607 5M1011012046AK7608 5M1011012046AK7609 5M1011012046AK7610 5M1011012046AK7611 5M1011012046AK7612 5M1011012046AK7613 5M1011012046AK7614 5M1011012046AK7615 5M1011012046AK7616 5M1011012046AK7617 5M1011012046AK7618 5M1011012046AK7619 5M1011012046AK7620 5M1011012046AK7621 5M1011012046AK7622 5M1011012046AK7623 5M1011012046AK7624 5M1011012046AK7625 5M1011012046AK7626 5M1011012046AK7627 5M1011012046AK7628 5M1011012046AK7629 5M1011012046AK7630 5M1011012046AK7631 5M1011012046AK7632 5M1011012046AK7633 5M1011012046AK7634 5M1011012046AK7635 5M1011012046AK7636 5M1011012046AK7637 5M1011012046AK7638 5M1011012046AK7639 5M1011012046AK7640 5M1011012046AK7641 5M1011012046AK7642 5M1011012046AK7643 5M1011012046AK7644 5M1011012046AK7645 5M1011012046AK7646 5M1011012046AK7647 5M1011012046AK7648 5M1011012046AK7649 5M1011012046AK7650 5M1011012046AK7651 5M1011012046AK7652 5M1011012046AK7653 5M1011012046AK7654 5M1011012102AL7776 5M1011012102AL7777 5M1011012102AL7778 5M1011012102AL7779 5M1011012102AL7780 5M1011012102AL7781 5M1011012102AL7783 5M1011012102AL7784 5M1011012102AL7785 5M1011012102AL7786 5M1011012102AL7787 5M1011012102AL7788 5M1011012102AL7789 5M1011012102AL7790 5M1011012102AL7791 5M1011012102AL7792 5M1011012102AL7793 5M1011012102AL7794 5M1011012102AL7795 5M1011012102AL7796 5M1011012102AL7797 5M1011012102AL7798 5M1011012102AL7799 5M1011012102AL7800 5M1011012102AL7801 5M1011012102AL7802 5M1011012102AL7803 5M1011012102AL7804 5M1011012102AL7805 5M1011012102AL7806 5M1011012102AL7807 5M1011012102AL7808 5M1011012102AL7809 5M1011012102AL7810 5M1011012102AL7811 5M1011012102AL7812 5M1011012102AL7813 5M1011012102AL7814 5M1011012102AL7815 5M1011012102AL7816 5M1011012102AL7817 5M1011012102AL7818 5M1011012102AL7819 5M1011012102AL7820 5M1011012102AL7821 5M1011012102AL7822 5M1011012102AL7823 5M1011012102AL7824 5M1011012102AL7825 5M1011012102AL7826 5M1011012102AL7827 5M1011012102AL7828 5M1011012102AL7829 5M1011012102AL7830 5M1011012102AL7831 5M1011012102AL7832 5M1011012102AL7833 5M1011012102AL7834 5M1011012102AL7835 5M1011012102AL7836 5M1011012102AL7837 5M1011012102AL7838 5M1011012102AL7839 5M1011012102AL7840 5M1011012102AL7841 5M1011012102AL7842 5M1011012102AL7843 5M1011012102AL7844 5M1011012102AL7845 5M1011012102AL7846 5M1011012102AL7847 5M1011012102AL7848 5M1011012102AL7849 5M1011012102AL7850 5M1011012102AL7851 5M1011012102AL7852 5M1011012102AL7853 5M1011012102AL7854 5M1011012102AL7855 5M1011012102AL7856 5M1011012102AL7857 5M1011012102AL7858 5M1011012102AL7859 5M1011012102AL7860 5M1011012102AL7861 5M1011012102AL7862 5M1011012102AL7863 5M1011012102AL7864 5M1011012102AL7865 5M1011012102AL7866 5M1011012102AL7867 5M1011012102AL7868 5M1011012102AL7869 5M1011012102AL7870 5M1011012102AL7871 5M1011012102AL7872 5M1011012102AL7873 5M1011012102AL7874 5M1011012102AL7875 5M1011012102AL7876 5M1011012102AL7877 5M1011012102AL7878 5M1011012102AL7879 5M1011012102AL7880 5M1011012102AL7881 5M1011012102AL7882 5M1011012102AL7883 5M1011012102AL7884 5M1011012102AL7885 5M1011012102AL7886 5M1011012102AL7887 5M1011012102AL7888 5M1011012102AL7889 5M1011012102AL7890 5M1011012102AL7891 5M1011012102AL7892 5M1011012102AL7893 5M1011012102AL7894 5M1011012102AL7895 5M1011012102AL7896 5M1011012102AL7897 5M1011012102AL7898 5M1011012102AL7899 5M1011012102AL7900 5M1011012102AL7901 5M1011012102AL7902 5M1011012102AL7903 5M1011012102AL7904 5M1011012102AL7905 5M1011012102AL7906 5M1011012102AL7907 5M1011012102AL7908 5M1011012102AL7909 5M1011012102AL7910 5M1011012102AL7911 5M1011012102AL7912 5M1011012102AL7913 5M1011012102AL7914 5M1011012102AL7915 5M1011012102AL7916 5M1011012102AL7917 5M1011012102AL7918 5M1011012102AL7919 5M1011012102AL7920 5M1011012102AL7921 5M1011012102AL7922 5M1011012102AL7923 5M1011012102AL7924 5M1011012102AL7925 5M1011012102AL7926 5M1011012102AL7927 5M1011012102AL7928 5M1011012102AL7929 5M1011012102AL7930 5M1011012102AL7931 5M1011012102AL7932 5M1011012102AL7933 5M1011012102AL7934 5M1011012102AL7935 5M1011012102AL7936 5M1011012102AL7937 5M1011012102AL7938 5M1011012102… (truncated, 150280 characters total — see the official FDA record for the full value)
Recalling firm:
Activbody, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled November 30, 2021

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64

Stronger than it should be Drug

ALL 50 STATES
Full report

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

Recall #:
D-0295-2022
Lot/product code:
Lot #: 16345, Exp. Date 01/2024
Recalling firm:
Teligent Pharma, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2021

Zenition 50, Model #718096

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

ALL 50 STATES
Full report

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

Recall #:
89437
Lot/product code:
Wireless Foot switch 3P : 459801238191  Wireless Foot switch 3P: 459801238231
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2021

Zenition 70, Model #718133

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

ALL 50 STATES
Full report

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

Recall #:
89437
Lot/product code:
Wireless Foot switch 3P : 459801238191  Wireless Foot switch 3P: 459801238231
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2021

Veradius Unity, Model #718132

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

ALL 50 STATES
Full report

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

Recall #:
89437
Lot/product code:
Wireless Foot switch 3P : 459801238191  Wireless Foot switch 3P: 459801238231
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2021

Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.

Incorrect product is contained in the packaging.

ALL 50 STATES
Full report

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

Recall #:
89086
Lot/product code:
Lot numbers 02010697711582590 and 02010697711582591, GTIN 00840420108340.
Recalling firm:
Wright Medical Technology, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2021

Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.

The incorrect product is contained in the packaging.

ALL 50 STATES
Full report

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

Recall #:
89089
Lot/product code:
Lot #1643355
Recalling firm:
Wright Medical Technology Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2021

Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.

The incorrect product is contained in the packaging.

ALL 50 STATES
Full report

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

Recall #:
89089
Lot/product code:
Lot #1642103
Recalling firm:
Wright Medical Technology Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 6, 2021

Alinity m System, Part No. 08N53-002

There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.

ALL 50 STATES
Full report

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

Recall #:
89168
Lot/product code:
Alinity m System, Model 08N53-002, all serial numbers
Recalling firm:
Abbott Molecular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 6, 2021

Alinity m System, Part No. 08N53-002

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.

ALL 50 STATES
Full report

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

Recall #:
89167
Lot/product code:
Alinity m System, Model 08N53-002, all serial numbers
Recalling firm:
Abbott Molecular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 6, 2021

Alinity m System, Part No. 08N53-002

There is a potential for abnormal (non-sigmoidal) amplification curves.

ALL 50 STATES
Full report

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

Recall #:
89166
Lot/product code:
Model 08N53-002, all serial numbers
Recalling firm:
Abbott Molecular, Inc.
View official FDA record (opens in a new tab)