BIGNOPE
Ko-fi

Recalls affecting Oklahoma

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

16,641 recalls found

Just announced

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

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

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

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

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 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

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 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)
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)
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 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 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 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 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 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 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 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 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)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2021

Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed,

Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.

ALL 50 STATES
Full report

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

Recall #:
89369
Lot/product code:
Serial Numbers: XCONUS0013 XCONUS0079 XCONUS0105 XCONUS0036 XCONUS0044 XCONUS0004 XCONUS0014 XCONUS0080 XCONUS0109 XCONUS0021 XCONUS0066 XCONUS0027 XCONUS0017 XCONUS0084 XCONUS0061 XCONUS0043 XCONUS0089 XCONUS0059 XCONUS0019 XCONUS0085 XCONUS0051 XCONUS0047 XCONUS0005 XCONUS0042 XCONUS0020 XCONUS0086 XCONUS0110 XCONUS0055 XCONUS0010 XCONUS0083 XCONUS0022 XCONUS0087 XCONUS0111 XCONUS0064 XCONUS0053 XCONUS0121 XCONUS0023 XCONUS0088 XCONUS0112 XCONUS0002 XCONUS0056 XCONUS0018 XCONUS0024 XCONUS0090 XCONUS0113 XCONUS0003 XCONUS0006 XCONUS0054 XCONUS0030 XCONUS0091 XCONUS0115 XCONUS0007 XCONUS0052 XCONUS0081 XCONUS0032 XCONUS0094 XCONUS0116 XCONUS0012 XCONUS0073 XCONUS0008 XCONUS0039 XCONUS0095 XCONUS0118 XCONUS0070 XCONUS0009 XCONUS0040 XCONUS0096 XCONUS0025 XCONUS0072 XCONUS0001 XCONUS0049 XCONUS0092 XCONUS0026 XCONUS0075 XCONUS0011 XCONUS0058 XCONUS0093 XCONUS0028 XCONUS0082 XCONUS0045 XCONUS0067 XCONUS0097 XCONUS0122 XCONUS0048 XCONUS0065 XCONUS0068 XCONUS0098 XCONUS0123 XCONUS0063 XCONUS0029 XCONUS0069 XCONUS0099 XCONUS0124 XCONUS0031 XCONUS0035 XCONUS0074 XCONUS0100 XCONUS0034 XCONUS0071 XCONUS0046 XCONUS0076 XCONUS0102 XCONUS0038 XCONUS0060 XCONUS0050 XCONUS0077 XCONUS0103 XCONUS0041 XCONUS0062 XCONUS0015 XCONUS0078 XCONUS0104 XCONUS0033 XCONUS0037 XCONUS0016 UDI: Prefix: 4057224 (+ serial number)
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 9, 2021

Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i Anesthesia System C30 6888530 07325710010624 Flow-i Anesthesia System C40 6888540 07325710010631 Flow-i C20 Anesthesia System 6677200 07325710001349 Flow-i C30 Anesthesia System 6677300 07325710001349 Flow-i C40 Anesthesia System 6677400 07325710001318

A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.

ALL 50 STATES
Full report

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

Recall #:
89125
Lot/product code:
UDI: 07325710008430 Serial Nos. 15580 15890 15924 16284 16637 16837 16970 15582 15891 15925 16285 16638 16840 16971 15721 15894 16268 16345 16639 16842 15722 15914 16269 16352 16640 16843 15725 15917 16270 16354 16690 16844 15726 15919 16271 16632 16828 16961 15728 15920 16272 16633 16832 16964 15729 15921 16273 16634 16833 16965 15731 15922 16276 16635 16834 16966 15732 15923 16283 16636 16836 16968
Recalling firm:
Getinge Usa Sales Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2021

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.

ALL 50 STATES
Full report

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

Recall #:
89383
Lot/product code:
Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341
Recalling firm:
Mallinckrodt Pharmaceuticals Ireland Ltd
View official FDA record (opens in a new tab)