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Recalls affecting Nevada

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

16,602 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 October 21, 2021

HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
Batches: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, 27393787 GTIN: 08714729283867 Exp. 05/09/2022 to 05/27/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
Batches: 25644951, 25649190, 25650286, 25651334, 25654287, 25947916, 25947918, 26010397, 26058298, 26406532, 26435581, 26449368, 26533973, 26555544, 26868194, 27074110, 27269956, 27384708. GTIN: 08714729283843 Exp. 05/27/2022 to 05/26/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
GTIN: 08714729283805 Lot Numbers: 25612668, 25649812, 25704208, 25771760, 25878552, 26000695, 26010387, 26058284, 26087172, 26087173, 26123181, 26324742, 26366746, 26406513, 26429808, 26499853, 26527374, 26573853, 26638827, 26651718, 26665448, 26893604, 27026984, 27074109, 27145234, 27162321, 27255235, 27306699. Exp. 05/19/2022 to 05/13/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301

Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.

Full report

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

Recall #:
88986
Lot/product code:
G300 with Windows XP. G301 with Windows 7 Embedded System.
Recalling firm:
AMO Manufacturing USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
GTIN: 08714729283836 Batches: 25576770, 25576881, 25576882, 25576883, 25576884, 25576885, 25608762, 25623386, 25623387, 25623388, 25623389, 25623390, 25623391, 25623392, 25623393, 25623394, 25623395, 25623396, 25623397, 25623398, 25649814, 25649817, 25649820, 25649821, 25649825, 25649826, 25649830, 25649831, 25678823, 25678827, 25678832, 25678837, 25680097, 25704217, 25704218, 25704219, 25704220, 25704221, 25704222, 25704223, 25739152, 25739153, 25739154, 25739155, 25739157, 25739158, 25771773, 25771774, 25771775, 25771776, 25771777, 25771778, 25836083, 25836084, 25836085, 25836086, 25836087, 25836088, 25836089, 25836090, 25836091, 25836092, 25878557, 25878558, 25878559, 25878980, 25878981, 25878982, 25878983, 25878984, 25878985, 25940124, 25940125, 25942723, 25947907, 25947909, 25947911, 25947913, 25947915, 25975775, 25975776, 25975777, 25975778, 25995786, 25996198, 26000471, 26000476, 26000477, 26000478, 26000479, 26000580, 26000700, 26010393, 26010394, 26010395, 26010396, 26058288, 26058291, 26058293, 26058294, 26058295, 26058296, 26058297, 26087734, 26087735, 26087736, 26087737, 26087738, 26087739, 26087740, 26087741, 26123187, 26123188, 26123189, 26123190, 26123191, 26123247, 26123248, 26123249, 26175470, 26175471, 26175472, 26175473, 26207983, 26207984, 26207985, 26207986, 26207987, 26207988, 26207989, 26207990, 26207991, 26238132, 26238133, 26238134, 26240368, 26240370, 26240371, 26240373, 26247248, 26247249, 26247250, 26247251, 26247252, 26247253, 26247254, 26247255, 26247256, 26247257, 26283632, 26283633, 26283634, 26283635, 26283636, 26283637, 26283638, 26283639, 26284140, 26284141, 26284142, 26284143, 26324749, 26324751, 26324752, 26324754, 26350404, 26350405, 26350406, 26350407, 26356444, 26366753, 26366754, 26366755, 26366756, 26366757, 26406522, 26406523, 26406524, 26406525, 26406526, 26406527, 26406528, 26406529, 26406530, 26406531, 26426921, 26426922, 26426923, 26428970, 26429811, 26429812, 26435537, 26435538, 26435539, 26435580, 26452047, 26456916, 26456917, 26462399, 26473523, 26473769, 26473770, 26473771, 26473772, 26473773, 26473774, 26495372, 26495950, 26500637, 26500638, 26512452, 26512453, 26512454, 26512455, 26512456, 26512457, 26512458, 26512459, 26512480, 26512481, 26512483, 26512485, 26549972, 26552065, 26556788, 26556789, 26559542, 26559543, 26559544, 26559548, 26581407, 26581408, 26582103, 26582104, 26582105, 26582106, 26582107, 26588072, 26588073, 26588074, 26588075, 26588076, 26628443, 26628444, 26638830, 26638831, 26651713, 26651714, 26651715, 26651716, 26665561, 26665567, 26665571, 26665572, 26665573, 26685875, 26685876, 26685877, 26685878, 26685879, 26699192, 26699193, 26699194, 26699195, 26699196, 26699197, 26728782, 26728784, 26728785, 26759345, 26760530, 26778894, 26778895, 26778896, 26778897, 26778898, 26779080, 26779081, 26779082, 26779083, 26793782, 26793783, 26793784, 26808197, 26808198, 26808199, 26808300, 26808301, 26808302, 26808303, 26848720, 26848721, 26848722, 26848723, 26848724, 26848725, 26871168, 26871169, 26871170, 26871171, 26871172, 26871173, 26871174, 26910997, 26910998, 26910999, 26911840, 26911841, 26911842, 26911845, 26919040, 26919041, 26919042, 26960166, 26960167, 26960168, 26960169, 26960170, 26960171, 26960172, 26960173, 26960174, 26960175, 27009668, 27027289, 27027290, 27027291, 27027292, 27062054, 27062055, 27062056, 27062057, 27065830, 27065831, 27065832, 27065833, 27065834, 27065835, 27100017, 27100018, 27100019, 27100240, 27100241, 27100242, 27110096, 27110097, 27121582, 27121583, 27121584, 27121585, 27121620, 27121621, 27121625, 27148636, 27148637, 27148638, 27162326, 27162327, 27162328, 27162329, 27182896, 27182897, 27182898, 27182899, 27203768, 27203769, 27203770, 27203771, 27203772, 27203773, 27255217, 27255219, 27255220, 27255221, 27255222, 27255223, 27308422, 27308423, 27308424, 27308425, 27335091, 27335092, 27335093, 27335094, 27340629, 27340630, 27340632, 27340633, 27340634, 27340638, 27347592, 27347593, 27384705, 27384706, 27384713, 27384715. Exp. 05/10/2022 to 05/26/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
GTIN: 8714729283829 Batches: 25623385, 25678822, 25739151, 25771772, 25975774, 26010392, 26051928, 26087733, 26123186, 26175469, 26406521, 26429810, 26456904, 26579839, 26581406, 26601326, 26660957, 26793786, 26896864, 27026985, 27096335, 27226570, 27255234, 27400203. Exp. 05/23/2022 to 05/28/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
Batches: 25608760, 25612672, 25649815, 25649818, 25649822, 25649823, 25649827, 25649828, 25649832, 25649833, 25678824, 25678828, 25678829, 25678833, 25678834, 25678838, 25680098, 25680099, 25704224, 25704225, 25704226, 25704227, 25704228, 25704229, 25739159, 25739160, 25739161, 25739162, 25739163, 25739164, 25739165, 25739166, 25739167, 25739168, 25788242, 25789369, 25789801, 25836093, 25836094, 25836095, 25836096, 25836097, 25836098, 25836099, 25836140, 25836141, 25836142, 25836143, 25836144, 25836145, 25878556, 25894780, 25894781, 25894782, 25916457, 25939485, 25939684, 25940126, 25940127, 25940131, 25947920, 25947921, 25975779, 25975780, 25975781, 25975782, 25975783, 25975784, 25975785, 25975786, 25975787, 26000581, 26000582, 26000583, 26000584, 26051925, 26051926, 26051927, 26058299, 26058420, 26058421, 26058422, 26058425, 26096221, 26096222, 26096223, 26099224, 26123192, 26123193, 26123194, 26123195, 26123196, 26123250, 26123251, 26175474, 26175475, 26175476, 26175477, 26175478, 26175479, 26175500, 26207992, 26207993, 26207994, 26207995, 26207996, 26207997, 26207998, 26238135, 26240374, 26240376, 26240377, 26240378, 26247258, 26247259, 26247280, 26247281, 26247282, 26247283, 26247284, 26247285, 26284144, 26284145, 26284146, 26284147, 26284148, 26284149, 26284150, 26284151, 26324756, 26324758, 26324760, 26324762, 26324764, 26324765, 26324767, 26350408, 26351999, 26356443, 26366758, 26366759, 26366760, 26366761, 26366762, 26366763, 26366764, 26366765, 26366766, 26395974, 26406533, 26406534, 26406535, 26406536, 26406537, 226435588, 26456918, 26456919, 26473775, 26473776, 26473777, 26473778, 26491312, 26491313, 26491314, 26491319, 26491480, 26512487, 26512488, 26512490, 26527375, 26527376, 26527377, 26527378, 26551465, 26551466, 26551467, 26551468, 26551470, 26577498, 26613121, 26614494, 26614495, 26614496, 26614497, 26614498, 26614800, 26614801, 26628445, 26628446, 26628447, 26651711, 26651712, 26665036, 26665037, 26665038, 26665039, 26665360, 26665361, 26696684, 26696685, 26696686, 26696687, 26706788, 26706789, 26706790, 26706791, 26706792, 26706793, 26706794, 26760454, 26760456, 26760458, 26760459, 26760520, 26760521, 26760522, 26760523, 26760524, 26760525, 26779085, 26799125, 26799126, 26799127, 26799128, 26799129, 26818882, 26818883, 26818884, 26818885, 26818886, 26818887, 26818888, 26818889, 26818890, 26818891, 26818892, 26848726, 26848727, 26848728, 26848729, 26848730, 26848731, 26888163, 26888164, 26888165, 26888166, 26888167, 26888168, 26910996, 26919048, 26919049, 26919050, 26919051, 26919341, 26990595, 26990596, 26990598, 26990599, 26990980, 26990981, 26990982, 27008813, 27008814, 27008815, 27008816, 27008817, 27009671, 27027284, 27027285, 27027286, 27027287, 27027288, 27055010, 27055018, 27062058, 27065836, 27065837, 27065838, 27065839, 27074113, 27074114, 27100243, 27100244, 27110098, 27110099, 27110720, 27121586, 27121587, 27121588, 27121589, 27148635, 27162330, 27162331, 27162332, 27183300, 27183301, 27183302, 27203774, 27203775, 27203776, 27203777, 27203778, 27203779, 27255225, 27255226, 27255227, 27255228, 27255229, 27255230, 27255231, 27255232, 27255233, 27265232, 27269957, 27269958, 27269959, 27308426, 27308427, 27335095, 27335096, 27335097, 27347594, 27347595, 27347596, 27384709, 27393786, 27407169, 27408779, 27408920, 274089216406538, 26426920, 26435582, 26435583, 26435585, 26435586, 26435587, 26435588, 26456918, 26456919, 26473775, 26473776, 26473777, 26473778, 26491312, 26491313, 26491314, 26491319, 26491480, 26512487, 26512488, 26512490, 26527375, 26527376, 26527377, 26527378, 26551465, 26551466, 26551467, 26551468, 26551470, 26577498, 26613121, 26614494, 26614495, 26614496, 26614497, 26614498, 26614800, 26614801, 26628445, 26628446, 26628447, 26651711, 26651712, 26665036, 26665037, 26665038, 26665039, 26665360, 26665361, 26696684, 26696685, 26696686, 26696687, 26706788, 26706789, 26706790, 26706791, 26706792, 26706793, 26706794, 26760454, 26760456, 26760458, 26760459, 26760520, 26760521, 26760522, 26760523, 26760524, 26760525, 26779085, 26799125, 26799126, 26799127, 26799128, 26799129, 26818882, 26818883, 26818884, 26818885, 26818886, 26818887, 26818888, 26818889, 26818890, 26818891, 26818892, 26848726, 26848727, 26848728, 26848729, 26848730, 26848731, 26888163, 26888164, 26888165, 26888166, 26888167, 26888168, 26910996, 26919048, 26919049, 26919050, 26919051, 26919341, 26990595, 26990596, 26990598, 26990599, 26990980, 26990981, 26990982, 27008813, 27008814, 27008815, 27008816, 27008817, 27009671, 27027284, 27027285, 27027286, 27027287, 27027288, 27055010, 27055018, 27062058, 27065836, 27065837, 27065838, 27065839, 27074113, 27074114, 27100243, 27100244, 27110098, 27110099, 27110720, 27121586, 27121587, 27121588, 27121589, 27148635, 27162330, 27162331, 27162332, 27183300, 27183301, 27183302, 27203774, 27203775, 27203776, 27203777, 27203778, 27203779, 27255225, 27255226, 27255227, 27255228, 27255229, 27255230, 27255231, 27255232, 27255233, 27265232, 27269957, 27269958, 27269959, 27… (truncated, 5190 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
GTIN: 08714729283812 Lot Numbers: 25576719, 25576720, 25576721, 25576769, 25611564, 25612669, 25612670, 25612671, 25612673, 25612674, 25623377, 25623378, 25623379, 25623380, 25623381, 25623382, 25623383, 25623384, 25640115, 25649813, 25649816, 25678821, 25678826, 25678831, 25678836, 25680096, 25704209, 25704210, 25704211, 25704212, 25704213, 25704214, 25704215, 25704216, 25739146, 25739147, 25739149, 25739150, 25771761, 25771762, 25771763, 25771764, 25771765, 25771766, 25771767, 25771768, 25771769, 25771770, 25771771, 25836081, 25836082, 25878553, 25878554, 25878555, 25894783, 25916270, 25916271, 25916445, 25916446, 25940122, 25940123, 25947675, 25947677, 25947678, 25947900, 25947902, 25947904, 25947905, 25975766, 25975767, 25975768, 25975769, 25975770, 25975771, 25975772, 25975773, 26000472, 26000473, 26000474, 26000475, 26000696, 26000697, 26000698, 26000699, 26010388, 26010389, 26010390, 26010391, 26058285, 26058286, 26087174, 26087175, 26087176, 26087177, 26087178, 26087179, 26087720, 26087721, 26087722, 26087723, 26087724, 26087725, 26087726, 26087727, 26087728, 26087729, 26087730, 26087731, 26087732, 26123182, 26123183, 26123184, 26123185, 26123244, 26123245, 26123246, 26175465, 26175466, 26175467, 26175468, 26207974, 26207975, 26207976, 26207977, 26207978, 26207979, 26207980, 26207981, 26207982, 26238131, 26240367, 26247246, 26247247, 26283625, 26283626, 26283627, 26283628, 26283629, 26283630, 26283631, 26324745, 26324747, 26344528, 26344529, 26348351, 26356445, 26366747, 26366748, 26366749, 26366750, 26366751, 26366752, 26406514, 26406515, 26406516, 26406517, 26406518, 26406519, 26406520, 26429809, 26435534, 26435535, 26435536, 26444430, 26447362, 26447363, 26449367, 26456914, 26456915, 26473765, 26473766, 26473767, 26473768, 26495948, 26499146, 26501878, 26511846, 26512444, 26512445, 26512446, 26512447, 26512448, 26512449, 26512450, 26512451, 26540309, 26556786, 26556787, 26559139, 26559540, 26559541, 26559546, 26559547, 26581401, 26581402, 26581403, 26581404, 26581405, 26582100, 26582101, 26582102, 26588068, 26588069, 26588070, 26588071, 26628440, 26628441, 26628442, 26638828, 26638829, 26651717, 26660956, 26665449, 26665450, 26665458, 26665560, 26677021, 26685872, 26685873, 26685874, 26699186, 26699187, 26699188, 26699189, 26699190, 26699191, 26728358, 26728359, 26728780, 26728781, 26769421, 26778891, 26778892, 26778893, 26792383, 26792384, 26792386, 26793780, 26793781, 26808194, 26808195, 26808196, 26818638, 26818639, 26818880, 26818881, 26848716, 26848717, 26848718, 26848719, 26872354, 26872355, 26872356, 26872357, 26872358, 26906626, 26906627, 26906628, 26906629, 26906630, 26906631, 26919043, 26919044, 26919045, 26919046, 26919047, 26940194, 26956470, 26956471, 26956472, 26956473, 26956474, 26956475, 26956476, 26956477, 26956478, 26956479, 27008818, 27008819, 27025671, 27027293, 27027294, 27027295, 27027296, 27027297, 27027298, 27027299, 27065828, 27065829, 27074111, 27074112, 27100015, 27100016, 27110095, 27121580, 27121581, 27121622, 27121623, 27121624, 27162322, 27162323, 27162324, 27162325, 27182893, 27182894, 27182895, 27183306, 27183307, 27183308, 27203712, 27203713, 27203714, 27203715, 27203716, 27203717, 27203718, 27203719, 27203760, 27203761, 27203762, 27203763, 27203764, 27203765, 27203766, 27203767, 27255211, 27255212, 27255213, 27255214, 27265231, 27269950, 27269951, 27269953, 27269954, 27269955, 27308420, 27308421, 27335099, 27335460, 27340626, 27340636, 27340637, 27347590, 27347591, 27384704, 27393782, 27408924 Exp. 05/10/2022 to 05/31/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031

If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.

ALL 50 STATES
Full report

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

Recall #:
91853
Lot/product code:
GTIN: (01)00884838076747 (Model 709030), (01)00884838101456 (Model 709031; Serial Numbers: 10000000 10000001 10000002 10000003 10000004 10000006 10000007 10000010 10000011 10000012 10000013 10000014 10000015 10000016 10000019 10000020 10000021 10000022 10000023 10000024 10000025 10000026 10000027 10000029 10000030 10000031 10000032 10000034 10000035 10000036 10000037 10000038 10000040 10000041 10000042 10000043 10000044 10000045 10000046 10000047 10000048 10000049 10000050 10000051 10000052 10000053 10000054 10000055 10000056 10000057 10000058 10000060 10000061 10000063 10000064 10000065 10000066 10000067 10000068 10000069 10000070 10000071 10000072 10000073 10000075 10000076 10000078 10000079 10000080 10000081 10000082 10000083 10000087 10000089 10000090 10000092 10000093 10000094 10000095 10000096 10000097 10000099 10000100 10000102 10000103 10000104 10000107 10000108 10000109 10000111 10000112 10000114 10000115 10000116 10000117 10000118 10000119 10000121 10000122 10000124 10000125 10000126 10000127 10000130 10000131 10000133 10000134 10000135 10000136 10000137 10000138 10000139 10000140 10000144 10000145 10000149 10000151 10000152 10000156 10000165 10000166 10000168 10000169 10000170 10000171 10000174 10000176 10000178 10000179 10000180 10000184 10000185 10000186 10000187 10000188 10000189 10000190 10000191 10000194 10000198 10000199 10000202 10001000 10001001 10001010 10001070 10001071 10001072 10001073 10001074 10001075 10001076 10001078 10001079 10001080 10001081 10001082 10001083 10001084 10001085 10001086 10001087 10001088 10001089 10001090 10001091 10001092 10001093 10001094 10001095 10001096 10001097 10001098 10001099 10001100 10001216 10001218 17000018 17000164 18000069 11201-10 24233-03 24592-122 28 7175_04 7896_04 SN16000001 SN16000002 SN16000003 SN16000004 SN16000006 SN16000007 SN16000008 SN16000009 SN17000001 SN17000002 SN17000003 SN17000004 SN17000006 SN17000007 SN17000008 SN17000009 SN17000010 SN17000011 SN17000012 SN17000013 SN17000014 SN17000015 SN17000016 SN17000017 SN17000018 SN17000019 SN17000020 SN17000021 SN17000022 SN17000023 SN17000024 SN17000101 SN17000102 SN17000103 SN17000104 SN17000105 SN17000106 SN17000107 SN17000108 SN17000109 SN17000110 SN17000111 SN17000112 SN17000113 SN17000114 SN17000115 SN17000116 SN17000117 SN17000118 SN17000119 SN17000120 SN17000121 SN17000122 SN17000123 SN17000124 SN17000126 SN17000127 SN17000128 SN17000129 SN17000130 SN17000131 SN17000132 SN17000133 SN17000134 SN17000135 SN17000136 SN17000137 SN17000138 SN17000139 SN17000140 SN17000141 SN17000142 SN17000143 SN17000144 SN17000145 SN17000146 SN17000147 SN17000148 SN17000149 SN17000150 SN17000151 SN17000152 SN17000153 SN17000154 SN17000155 SN17000156 SN17000157 SN17000158 SN17000159 SN17000160 SN17000161 SN17000162 SN17000163 SN17000164 SN17000165 SN17000166 SN17000167 SN17000168 SN17000169 SN17000170 SN17000171 SN17000227 SN18000001 SN18000002 SN18000003 SN18000004 SN18000005 SN18000006 SN18000007 SN18000008 SN18000009 SN18000010 SN18000011 SN18000012 SN18000013 SN18000014 SN18000015 SN18000016 SN18000017 SN18000018 SN18000019 SN18000020 SN18000021 SN18000022 SN18000023 SN18000024 SN18000025 SN18000026 SN18000027 SN18000028 SN18000029 SN18000030 SN18000031 SN18000032 SN18000033 SN18000034 SN18000035 SN18000036 SN18000037 SN18000038 SN18000039 SN18000041 SN18000044 SN18000045 SN18000046 SN18000047 SN18000048 SN18000049 SN18000050 SN18000051 SN18000052 SN18000053 SN18000054 SN18000055 SN18000056 SN18000057 SN18000058 SN18000060 SN18000061 SN18000062 SN18000063 SN18000064 SN18000065 SN18000066 SN18000067 SN18000068 SN18000069 SN18000070 SN18000071 SN18000072 SN18000073 SN18000074 SN18000075 SN18000076 SN18000077 SN18000078 SN18000079 SN19000001 SN19000002 SN19000003 SN19000004 SN19000005 SN19000006 SN19000007 SN19000008 SN19000009 SN19000010 SN19000011 SN19000012 SN19000013 SN19000014 SN19000015 SN19000016 SN19000017 SN19000018 SN19000019 SN19000020 SN19000021 SN19000022 SN19000023 SN19000024 SN19000025 SN19000026 SN19000027 SN19000028 SN19000029 SN19000030 SN19000031 SN19000032 SN19000033 SN19000034 SN19000035 SN19000036 SN19000037 SN19000038 SN19000039 SN19000040 SN19000041 SN19000042 10001004 10001005 10001006 10001008 10001009 10001010 10001011 10001012 10001013 10001018 10001020 10001022 10001024 10001026 10001027 10001028 10001029 10001030 10001031 10001032 10001035 10001036 10001043 10001044 10001045 10001046 10001047 10001048 10001049 10001050 10001051 10001052 10001053 10001054 10001055 10001056 10001057 10001058 10001059 10001060 10001061 10001062 10001063 10001064 10001065 10001066 10001067 10001068 10001069 10001070 10001071 10001072 10001073 10001074 10001075 10001076 10001077 10001078 10001079 10001080 10001081 10001083 10001084 10001085 10001086 10001087 10001088 10001089 10001090 10001091 10001092 10001093 10001093 10001094 10001095 10001096 10001097 10001098 10001099 10001100 10001101 10001102 10001103 10001104 10001105 10001106 10001107 10001108 10001109 10001110 10001111 10001112 1000… (truncated, 5112 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 October 21, 2021

ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110

If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.

ALL 50 STATES
Full report

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

Recall #:
91853
Lot/product code:
GTIN: (01)00884838085619 (Model 706100), (01)00884838103221 (Model 709031); Serial Numbers: 597241 10000000 10000001 10000004 10000005 10000006 10000008 10000009 10000010 10000011 10000012 10000013 10000014 10000015 10000016 10000017 10000018 10000019 10000020 10000021 10000022 10000023 10000024 10000025 10000026 10000027 10000028 10000030 10000031 10000032 10000033 10000034 10000035 10000036 10000037 10000039 10000040 10000041 10000042 10000043 10000044 10000045 10000046 10000047 10000048 10000049 10000050 10000051 10000052 10000053 10000054 10000055 10001013 10001014 10001015 10001017 10001018 10001019 10001020 10001021 10001022 10001023 10001024 10001025 10001026 10001027 10001028 10001029 10001030 10001031 10001032 10001033 10001034 10001035 10001036 10001037 10001038 10001039 10001040 10001041 10001042 10001043 10001044 10001046 10001047 10001048 10001049 10001050 10001051 10001053 10001054 10001059 18000001 20000022 20000026 20000034 20000044 20000045 20000046 20000051 20000052 20000054 20000055 20000061 20000062 20000063 20000064 20000065 20000066 20000067 20000068 20000069 20000070 20000071 20000072 20000073 20000074 20000077 20000078 20000079 20000081 20000082 20000083 20000085 20000086 20000089 721815121706 SN10001000 SN10001001 SN10001002 SN10001003 SN10001004 SN10001005 SN10001006 SN10001007 SN10001008 SN10001009 SN10001010 SN10001011 SN10001012 SN18000001 SN18000002 SN18000003 SN18000004 SN18000005 SN18000006 SN18000007 SN18000008 SN18000009 SN18000011 SN18000012 SN18000013 SN18000014 SN18000015 SN18000016 SN18000017 SN18000018 SN18000019 SN18000020 SN18000021 SN18000022 SN18000023 SN18000024 SN18000152 SN18000249 SN19000001 SN19000002 SN19000003 SN19000004 SN19000005 SN19000006 SN19000007 SN19000008 SN19000009 SN19000010 SN19000011 SN19000012 SN19000013 SN19000014 SN19000015 SN19000016 SN19000017 SN19000018 10001057 10001064 10001059 10001058 10001062 10001069 10001052 10001060 10001070 10001061 10001063 10001068 10001067 10001066 10001073 10001065 10001103 10001075 10001079 10001085 10001084 10001074 10001106 10001087 10001088 10001076 10001086 10001093 10001091 10001089 10001100 10001099 10001104 10001078 10001098 10001102 10001105 10001072 10001096 10001090 10001077 10001118 10001109 10001110 10001107 10001112 10001092 10001111 10001113 10001101 10001116 10001108 10001045 10001055 10001083 10001095 10001094 10001071 10001082 10001080
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
Batches: 25608761, 25640116, 25640117, 25644834, 25649819, 25649824, 25649829, 25649834, 25678825, 25678830, 25678835, 25678839, 25678880, 25680560, 25704230, 25704231, 25704232, 25739169, 25739170, 25806714, 25819946, 25819947, 25819948, 25836147, 25836148, 25850475, 25850476, 25850477, 25850478, 25850479, 25850540, 25850541, 25878986, 25878987, 25878988, 25878989, 25878990, 25878991, 25930854, 25940128, 25940129, 25940130, 25963979, 25969161, 25969162, 25975788, 25975789, 25975790, 25975791, 26010399, 26010400, 26047895, 26047896, 26047897, 26047898, 26047899, 26048760, 26058432, 26059172, 26123198, 26123199, 26123240, 26123241, 26123242, 26123243, 26123252, 26123253, 26175502, 26175503, 26175504, 26175505, 26207999, 26208000, 26208001, 26208002, 26208003, 26240379, 26247286, 26247287, 26247288, 26247289, 26284152, 26284153, 26284154, 26284155, 26284156, 26324769, 26324771, 26324773, 26324775, 26350409, 26356442, 26366767, 26366768, 26366769, 26366770, 26366771, 26366772, 26366773, 26366774, 26406539, 26406560, 26406561, 26406562, 26435589, 26435590, 26435591, 26440046, 26457040, 26457041, 26473800, 26473801, 26489988, 26491481, 26491482, 26491483, 26491484, 26499145, 26543699, 26545849, 26545850, 26545851, 26546369, 26549973, 26559545, 26581409, 26581410, 26581827, 26600543, 26600544, 26621751, 26628098, 26638074, 26651704, 26651705, 26651706, 26651709, 26674679, 26675080, 26675081, 26677000, 26677001, 26677002, 26686240, 26696688, 26696689, 26706795, 26706796, 26706797, 26718376, 26718377, 26739329, 26739331, 26739335, 26758738, 26759340, 26759342, 26760526, 26760527, 26760528, 26760529, 26779086, 26779087, 26779088, 26779089, 26779090, 26779092, 26779093, 26808304, 26808305, 26808306, 26808307, 26848733, 26848734, 26848735, 26848736, 26848737, 26888169, 26888170, 26888171, 26888172, 26919342, 26919343, 26919344, 26919345, 26940195, 26940196, 26940197, 26940198, 26990983, 26990984, 26990985, 26990986, 26990987, 26990988, 26990989, 26990990, 26990991, 27008809, 27008810, 27008811, 27008812, 27055019, 27055120, 27062059, 27065900, 27065901, 27074115, 27074116, 27121590, 27121591, 27121596, 27121598, 27121599, 27121626, 27148639, 27148780, 27148781, 27183303, 27183304, 27183305, 27183311, 27183312, 27219848, 27220333, 27233915, 27263158, 27263159, 27265233, 27265234, 27269980, 27269981, 27269982, 27308428, 27335462, 27347597, 27347598, 27384710, 27428069 GTIN: 08714729283874 Exp. 05/18/2022 to 06/03/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 22, 2021

The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.

Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient

ALL 50 STATES
Full report

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

Recall #:
88923
Lot/product code:
Product Code/REF Number 2002-400; Lot codes: 441533, 443300, 443608, 443629, 444473, 445527, 448966, 449683, 450899, 450900, 451270, 451988, 452177, 452814, 454577, 455871, 458264, 458604, 459198, 459642, 462192, 462194, 464075, 464076, 465037, 466247, 469921, 470627, 471651,471703, 472562, 472785 and 473725.  UDI Code: 00650862100211
Recalling firm:
Atrium Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 22, 2021

Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.

ALL 50 STATES
Full report

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

Recall #:
88876
Lot/product code:
All serial numbers.
Recalling firm:
Thoratec Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 26, 2021

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

Excessive ultraviolet-C radiation

ALL 50 STATES
Full report

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

Recall #:
89050
Lot/product code:
Safe-T Lite
Recalling firm:
MAX LUX CORP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 28, 2021

OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.

ALL 50 STATES
Full report

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

Recall #:
88990
Lot/product code:
Product#/Brand Name/UDI Code: 450-0005-00 / OsteoMed OsteoPower Power Console 2i / 0084569401211 450-0021-00 / OsteoMed OsteoPower Power Console 2 / 0084569401215 450-0390 / OsteoMed BMF Footswitch / 0084569401215 450-0005-01 / OsteoMed D-Power Control Console 2i / 0084569401211 450-0021-01 / OsteoMed D-Power Control Console 2 / 0084569401211 ECOS-450-0021-00 / Power Control Console 2 / 0084569401211 ECOS-450-0005-00 / Power Control Console 2i / 0084569401211 Serial Numbers: 0332004 450-0005-01 0422006 450-0005-00 0423001 450-0005-01 0434003 S 0434004 S 0434010 S 0443004 0423005 450-0005-01 0449004s 0509004S 0509005S 0506027 0445003 0445005 9912003 0515009 0525014 0532001 0521042 0521045 0535006 0535007 0537031 0537032 0537033 0537034 0540005 0547022 0551022 0551025 0552008 0552009 0611004 0604070 0616001 0616002 0615005 0615009 0615010 0615039 0616003 0616005 0615041 0620004 0620005 0622022 0622023 0633024 0641004 0643068 0645002 0645003 0641009 0648023 0648025 0649002 0649003 0701004 0702021 0701005 0640004 0701006 0701009 0704036 0651097 0714001 0714002 0715029 0715031 0715032 0718003 0719005 0722041 0727024 0727025 0721005 0729044 0734030 0738015 0738017 0740001 0743032 0743033 0743034 0741013 0743036 0743037 0750022 0743038 0750023 0739022 0739023 0803016 0808001 0751032 0811002 0805025 0807056 0820004 0820004 0822030 0832057 0835005 0835004 0839048 0839048 0839049 0839049 0843053 0843054 0852046 0852002 0922072 0931001 0931003 0940011 0944016 0944006 0951020 0949001 1011002 1011003 1004051 1004052 1019002 1004054 1004055 1022048 1019005 1032001 1024002 1034007 1034008 1033010 1034009 1034010 1046013 1041033 1038009 1050036 1047020 1108032 1108033 1109006 1051004 1052014 1123010 1123012 1128022 1128023 1128026 1146012 1152006 0008006 9916005 1152007 1116005 1203041 1152008 1152009 1138003 1138005 1211003 9847002 1213003 1213004 1211005 1216001 1226008 1236044 1236040 1226007 1216002 1233042 1240054 1240055 1233041 1216005 1233045 1242003 1249002 1242004 1249003 1303005 1303002 1306002 1249005 1312002 1312003 1306004 1306005 1306001 0002001 1317012 0023005S 9916008 1240056 1317002 1317004 1336014 1340002 1340005 1341001 1341002 1346001 1346010 1346003 1349003 1349004 1341003 1349005 1351013 1346002 1405005 1405006 1420002 1420003 1405002 1417005 1424008 1424009 1424010 1417006 1434001 1434002 1434003 1434004 1441001 1441002 1441004 1445007 1445008 0244009 0720026 1509001 1509003 1516001 1516002 1518002 1521001 1521001 1521003 1521003 1528001 1528003 1528004 1528005 9942003 1533004 1533005 1528006 1537001 1537002 1537003 1539032 1539033 1539034 1547005 1547009 1543009 1553003 1543010 1604022 1604021 1614009 1134004 1614012 1614014 1604025 1604025 1610028 1610031 1610032 0603007 1410002 1620009 0232001 0548003 1622021 1604024 1610030 1622022 1622023 1622024 1638026 1634018 1634019 1638028 1638029 1634020 1634022 1638034 1638034 1634023 1634023 1634024 1634024 1634025 1634025 1639056 1639056 1639057 1639057 1639058 1644011 1644013 1643017 1644014 1644015 1644015 1643018 1651024 1651026 1644016 1651006 1707004 1707004 1707009 1707009 1651007 1651007 1710003 1710004 1651008 1651009 1651010 1651011 1712018 1710006 1710007 1711062 1711064 1711066 1711067 1715015 1651013 1711060 1711061 1715007 1715008 0751070 1719021 1719022 1719023 1711065 1713012 1721013 0651095 0051007S 1713013 1713014 1713015 1713016 1721015 1721016 1721017 1721018 1721019 1721014 1713017 1713018 1713019 1722009 1737018 1737017 1722011 1722012 1737019 1737020 1743001 1722013 1722014 1722015 1722016 1722017 1722018 1743009 1743007 1743008 1743010 1746027 1734014 1734015 1734016 1746031 1746030 1734017 1734018 1748010 1734019 1734020 1748009 1748001 1748003 1748006 1748007 1817052 1817053 1817054 1817055 1817056 1804002 1804010 1804001 1804003 1804004 1804005 1804007 1804006 1823017 1822008 1822010 1822014 1835012 1835013 1835020 1004053 1838001 1822015 1822016 1848001 1838003 1838004 1838005 1848002 1849017 1849019 1838006 1838007 1838008 1838009 1838010 1846025 1901001 1901002 1848003 1901003 1901004 1904003 1901009 1901010 1846026 1846027 1904001 1904002 1907011 1907012 1907013 1904004 1904005 1904006 1904007 1904008 1904009 1904010 1910031 1910032 1910033 1910034 1928046 1910035 1910036 1910037 1928047 1928048 1910039 1928049 1928050 1934001 1934002 1934003 1934004 1934005 1934006 1915001 1915002 1915003 1915004 1915005 1915006 1915007 1915008 1915009 1915010 1941001 1946002 1941002 1941003 1941004 1946003 1946004 1946005 2002034 1941005 2014016 2014017 2014018 2014019 2014020 1941006 2038001 2038002 1941007 1941008 2038003 2038004 2038005 2038006 2038007 2038008 1941009 2008002 2038009 2008003 2008004 2041001 0639018 2008005 2041002 2008001 2041003 2041006 2041007 2041008 2008007 2008008 2008009 2008010 2014001 2041009 2014002 2014003 2014004 ========================================================= -450-0380 / D-Bi-Directional Master Footswitch / 0084569401215 -450-0350 / D-Uni-Directional Footswitch II / 0084569401215 -450-0360 /… (truncated, 9865 characters total — see the official FDA record for the full value)
Recalling firm:
Osteomed, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 28, 2021

Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria (repeatability within 4%).

ALL 50 STATES
Full report

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

Recall #:
95017
Lot/product code:
DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
Recalling firm:
Palodex Group Oy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 29, 2021

NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL HEC4-000 PA0709-010 END CAP, 10MM HUMERAL NAIL HEC5-000 PA0709-015 END CAP, 15MM HUMERAL NAIL LSB3-020 PP1699-020 Locking Screw, 3.5mm x 2 0mm LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg LSB3-450-S PA1220-045 3.5mm x 45mm Screw, Peg LSB3-500-S PA1220-050 3.5mm x 50mm Screw, Peg LSB3-550-S PA1220-055 3.5mm x 55mm Screw, Peg LSB3-600-S PA1220-060 3.5mm x 60mm Screw, Peg LSB4-020 PP1425-020 Locking Screw, 4.0mm x 20mm LSB4-025 PP1425-025 Locking Screw, 4.0mm x 25mm LSB4-030 PP1425-030 Locking Screw, 4.0mm x 30mm LSB4-035 PP1425-035 Locking Screw, 4.0mm x 35mm LSB4-040 PP1425-040 Locking Screw, 4.0mm x 40mm LSB4-045 PP1425-045 Locking Screw, 4.0mm x 45mm LSB4-050 PP1425-050 Locking Screw, 4.0mm x 50mm LSB4-055 PP1425-055 Locking Screw, 4.0mm x 55mm LSB4-060 PP1425-060 Locking Screw, 4.0mm x 60mm LSB5-020 PP1426-020 Locking Screw, 5.0mm x 20mm LSB5-025 PP1426-025 Locking Screw, 5.0mm x 25mm LSB5-030 PP1426-030 Locking Screw, 5.0mm x 30mm LSB5-035 PP1426-035 Locking Screw, 5.0mm x 35mm LSB5-040 PP1426-040 Locking Screw, 5.0mm x 40mm LSB5-045 PP1426-045 Locking Screw, 5.0mm x 45mm LSB5-050 PP1426-050 Locking Screw, 5.0mm x 50mm LSB5-055 PP1426-055 Locking Screw, 5.0mm x 55mm LSB5-060 PP1426-060 Locking Screw, 5.0mm x 60mm LSB5-065 PP1426-065 Locking Screw, 5.0mm x 65mm LSB5-070 PP1426-070 Locking Screw, 5.0mm x 70mm LSB5-075 PP1426-075 Locking Screw, 5.0mm x 75mm LSC4-020 PP1794-020 Locking Screw, 4.0mm x 2 0mm LSC4-025 PP1794-025 Locking Screw, 4.0mm x 2 5mm LSC4-030 PP1794-030 Locking Screw, 4.0mm x 3 0mm LSC4-035 PP1794-035 Locking Screw, 4.0mm x 3 5mm LSC4-040 PP1794-040 Locking Screw, 4.0mm x 4 0mm LSC4-045 PP1794-045 Locking Screw, 4.0mm x 4 5mm LSC4-050 PP1794-050 Locking Screw, 4.0mm x 5 0mm LSC4-055 PP1794-055 Locking Screw, 4.0mm x 5 5mm LSC4-060 PP1794-060 Locking Screw, 4.0mm x 6 0mm LSC4-200-S PA1221-020 4.0mm x 20mm Screw, Peg LSC4-250-S PA1221-025 4.0mm x 25mm Screw, Peg LSC4-300-S PA1221-030 4.0mm x 30mm Screw, Peg LSC4-350-S PA1221-035 4.0mm x 35mm Screw, Peg LSC4-400-S PA1221-040 4.0mm x 40mm Screw, Peg LSC4-450-S PA1221-045 4.0mm x 45mm Screw, Peg LSC4-500-S PA1221-050 4.0mm x 50mm Screw, Peg LSC4-550-S PA1221-055 4.0mm x 55mm Screw, Peg LSC4-600-S PA1221-060 4.0mm x 60mm Screw, Peg LSC5-020 PP1742-020 Locking Screw, 5.0mm x 2 0mm LSC5-025 PP1742-025 Locking Screw, 5.0mm x 2 5mm LSC5-030 PP1742-030 Locking Screw, 5.0mm x 3 0mm LSC5-035 PP1742-035 Locking Screw, 5.0mm x 3 5mm LSC5-040 PP1742-040 Locking Screw, 5.0mm x 4 0mm LSC5-045 P

The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

Full report

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

Recall #:
89001
Lot/product code:
All Lots manufactured between April 2015 to February 2021 UDI/Model No./Item No./Product Description: 812258020002 CPA1-000 PA0382-001 End Cap 887517001139 CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM 887517001146 CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM 887517001153 CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM 887517001160 CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM 887517001177 CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM 887517001184 CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM 887517001191 CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM 887517001207 CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM 887517001214 CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM 887517001221 CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM 812258028121 HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL 812258028138 HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL 812258028145 HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL 812258028152 HEC4-000 PA0709-010 END CAP, 10MM HUMERAL NAIL 812258028169 HEC5-000 PA0709-015 END CAP, 15MM HUMERAL NAIL 812258021337 LSB3-020 PP1699-020 Locking Screw, 3.5mm x 2 0mm 812258021344 LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm 812258021351 LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm 812258021368 LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm 812258021375 LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm 812258021382 LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm 812258021399 LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm 812258021405 LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm 812258021412 LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm 00887517029027 LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg 00887517029010 LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg 00887517029003 LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg 00887517028990 LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg 00887517028983 LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg 00887517028976 LSB3-450-S PA1220-045 3.5mm x 45mm Screw, Peg 00887517028969 LSB3-500-S PA1220-050 3.5mm x 50mm Screw, Peg 00887517028952 LSB3-550-S PA1220-055 3.5mm x 55mm Screw, Peg 00887517028945 LSB3-600-S PA1220-060 3.5mm x 60mm Screw, Peg 856719002763 LSB4-020 PP1425-020 Locking Screw, 4.0mm x 20mm 856719002770 LSB4-025 PP1425-025 Locking Screw, 4.0mm x 25mm 856719002787 LSB4-030 PP1425-030 Locking Screw, 4.0mm x 30mm 856719002794 LSB4-035 PP1425-035 Locking Screw, 4.0mm x 35mm 856719002800 LSB4-040 PP1425-040 Locking Screw, 4.0mm x 40mm 856719002817 LSB4-045 PP1425-045 Locking Screw, 4.0mm x 45mm 856719002824 LSB4-050 PP1425-050 Locking Screw, 4.0mm x 50mm 856719002831 LSB4-055 PP1425-055 Locking Screw, 4.0mm x 55mm 856719002848 LSB4-060 PP1425-060 Locking Screw, 4.0mm x 60mm 856719002886 LSB5-020 PP1426-020 Locking Screw, 5.0mm x 20mm 856719002893 LSB5-025 PP1426-025 Locking Screw, 5.0mm x 25mm 856719002909 LSB5-030 PP1426-030 Locking Screw, 5.0mm x 30mm 856719002916 LSB5-035 PP1426-035 Locking Screw, 5.0mm x 35mm 856719002923 LSB5-040 PP1426-040 Locking Screw, 5.0mm x 40mm 856719002930 LSB5-045 PP1426-045 Locking Screw, 5.0mm x 45mm 856719002947 LSB5-050 PP1426-050 Locking Screw, 5.0mm x 50mm 856719002954 LSB5-055 PP1426-055 Locking Screw, 5.0mm x 55mm 856719002961 LSB5-060 PP1426-060 Locking Screw, 5.0mm x 60mm 856719002978 LSB5-065 PP1426-065 Locking Screw, 5.0mm x 65mm 856719002985 LSB5-070 PP1426-070 Locking Screw, 5.0mm x 70mm 856719002992 LSB5-075 PP1426-075 Locking Screw, 5.0mm x 75mm 812258021429 LSC4-020 PP1794-020 Locking Screw, 4.0mm x 2 0mm 812258021436 LSC4-025 PP1794-025 Locking Screw, 4.0mm x 2 5mm 812258021443 LSC4-030 PP1794-030 Locking Screw, 4.0mm x 3 0mm 812258021450 LSC4-035 PP1794-035 Locking Screw, 4.0mm x 3 5mm 812258021467 LSC4-040 PP1794-040 Locking Screw, 4.0mm x 4 0mm 812258021474 LSC4-045 PP1794-045 Locking Screw, 4.0mm x 4 5mm 812258021481 LSC4-050 PP1794-050 Locking Screw, 4.0mm x 5 0mm 812258021498 LSC4-055 PP1794-055 Locking Screw, 4.0mm x 5 5mm 812258021504 LSC4-060 PP1794-060 Locking Screw, 4.0mm x 6 0mm 00887517028938 LSC4-200-S PA1221-020 4.0mm x 20mm Screw, Peg 00887517028921 LSC4-250-S PA1221-025 4.0mm x 25mm Screw, Peg 00887517028914 LSC4-300-S PA1221-030 4.0mm x 30mm Screw, Peg 00887517028907 LSC4-350-S PA1221-035 4.0mm x 35mm Screw, Peg 00887517028891 LSC4-400-S PA1221-040 4.0mm x 40mm Screw, Peg 00887517028884 LSC4-450-S PA1221-045 4.0mm x 45mm Screw, Peg 00887517028877 LSC4-500-S PA1221-050 4.0mm x 50mm Screw, Peg 00887517028860 LSC4-550-S PA1221-055 4.0mm x 55mm Screw, Peg 00887517028853 LSC4-600-S PA1221-060 4.0mm x 60mm Screw, Peg 812258021511 LSC5-020 PP1742-020 Locking Screw, 5.0mm x 2 0mm 812258021528 LSC5-025 PP1742-025 Locking Screw, 5.0mm x 2 5mm 812258021535 LSC5-030 PP1742-030 Locking Screw, 5.0mm x 3 0mm 812258021542 LSC5-035 PP1742-035 Locking Screw, 5.0mm x 3 5mm 812258021559 LSC5-040 PP1742-040 Locking Screw, 5.0mm x 4 0mm 812258021566 LSC5-045 PP1742-045 Locking Screw, 5.0mm x 4 5… (truncated, 132877 characters total — see the official FDA record for the full value)
Recalling firm:
NuVasive Specialized Orthopedics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 29, 2021

Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722065, 722066, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. Wireless footswitch Models: 459801319471, 459801319521, 459801319361, 459801319421, 459801319481, 459801319531, 459801319511, 459801319541, 459801319371, 459801319431, 459801319391, 459801319441, 459801238241, 459801238231, 459801238261, 459801238251, 459801238201, 459801238191, 459801238221, 459801238211, 459801733051, 459801733061, 459801733071, 459801733081, 459801257861, 459801733091

Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure

ALL 50 STATES
Full report

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

Recall #:
89044
Lot/product code:
Wireless foot switches Models: WFS Ad7(X) Option 3P 459801319471; WFS Ad7(X) Option 4P+2 459801319521; WFS Ad7(X) Option 3P 459801319361; WFS Ad7(X) Option 4P+2 459801319421; WFS Field Extension Set 3P (ORT) 459801319481; WFS Field Extension Set 4P+2 (ORT) 459801319531; WFS Field Extension Set 3P 459801319511; WFS Field Extension Set 4P+2 459801319541; WFS Field Extension Set Mono 459801319371; WFS Field Extension Set Biplane 459801319431; WFS Field Extension Set Mono (ORT) 459801319391; WFS Field Extension Set Biplane (ORT) 459801319441; Wireless Footswitch Set 3P 459801238241; Wireless Footswitch 3P 459801238231; Wireless Footswitch Set 4P+2 459801238261; Wireless Footswitch 4P+2 459801238251 Wireless Footswitch Set JP 459801238201; Wireless Footswitch 3P 459801238191; Wireless Footswitch Set 4P+2 459801238221; Wireless Footswitch 4P+2 459801238211; Wireless Footswitch 3P Kit 459801733051; Wireless Footswitch 3P Kit 459801733061; Wireless Footswitch 4P+2 Kit 459801733071; Wireless Footswitch 4P+2 Kit 459801733081; WFS Base Station 459801257861; WFS Base Station Kil 459801733091.
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 1, 2021

Hanger-Bar 2P 45cm

The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw loosening, there is the potential for a fall hazard.

ALL 50 STATES
Full report

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

Recall #:
89509
Lot/product code:
Part Number 72754 UPC Code: 881608800397 EAN Code: 7331599999707 Lot Number: 33218501
Recalling firm:
Human Care USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 1, 2021

Hanger-Bar 2P 45cm

The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw loosening, there is the potential for a fall hazard.

ALL 50 STATES
Full report

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

Recall #:
89509
Lot/product code:
Part Number 72755 UPC Code: 881608800403 EAN Code: 7331599999714 Lot Number: 33164504
Recalling firm:
Human Care USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MEQ001 21AEQ00 21BEQ001 21BEQ002 21BEQ003 21CEQ001 21DEQ001 21DEQ002 21EEQ001 21EEQ002 21FEQ001 21FEQ002 21GEQ001 21HEQ001 21HEQ002 21JEQ001 21JEQ002. UDI: 50192253018989 (cs) 10192253018981 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MBQ001 21ABQ001 21ABQ002 21BBQ002 21BBQ003 21BBQ004 21BBQ005 21CBQ002 21CBQ003 21DBQ003 21DBQ004 21DBQ005 21EBQ003 21EBQ004 21EBQ005 21FBQ002 21FBQ003 21FBQ004 21FBQ005 21HBQ001 21HBQ002 21JBQ002 UDI: 50192253018996 (cs) 10192253018998 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50192253018927 (Cs) 10192253018929 (Ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MDQ014 21ADQ007 21CDQ004 21CDQ005 21DDQ001 21DDQ002 21EDQ001 21FDQ001 21GDQ001 21HDQ001 21JDQ003. UDI: 50192253018972 (cs) 10192253018974 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)