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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

Just announced

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

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

Products contain undeclared yohimbine

▸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/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

▸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/virusAnnounced September 3, 2026

Great Value — Organic 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)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

▸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)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey 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)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

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)

Recalls nationwide

Data last updated: September 8, 2026 at 1:13 PM UTC

19,424 recalls found
NewestOldest
High riskLow riskAll
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2026

Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

MA
▸Full report

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

Recall #:
99102
Lot/product code:
All Lots within Expiry/GTIN:00885672009755/00813502011609
Recalling firm:
Oscor Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2026

Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

MA
▸Full report

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

Recall #:
99102
Lot/product code:
All Lots within Expiry/GTIN:00885672009786/00813502010558
Recalling firm:
Oscor Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2026

Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

AZCACOCTFLGAIDILINLAMDMIMOMSMTNCNYOHORSCSDTXUTVAWAWI
▸Full report

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

Recall #:
99225
Lot/product code:
All Lots/GTIN# 18032568866650
Recalling firm:
Orthofix U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2026

Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

AZCACOCTFLGAIDILINLAMDMIMOMSMTNCNYOHORSCSDTXUTVAWAWI
▸Full report

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

Recall #:
99225
Lot/product code:
All Lots; GTIN# 18032568866681
Recalling firm:
Orthofix U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled June 10, 2026

Pepperoni Rolls, Net Wt. 5 oz (141g), individually packaged in a clear plastic bag, UPC 601959803041

Not listed on the label allergen (milk) and process deviation (product not held under refrigeration as required)

OHWV
▸Full report

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

Recall #:
H-1136-2026
Lot/product code:
Sell by dates 061226 through 062126
Recalling firm:
Fry Pie Factory LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2026

Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267

Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.

ALL 50 STATES
▸Full report

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

Recall #:
99318
Lot/product code:
UDI-DI 10198459538827 Kit Lots 26DMB644 26CMC467
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2026

Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J

Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.

ALL 50 STATES
▸Full report

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

Recall #:
99318
Lot/product code:
UDI-DI 10195327388447 Kit Lot 26DME172
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2026

Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

AZCACOCTFLGAIDILINLAMDMIMOMSMTNCNYOHORSCSDTXUTVAWAWI
▸Full report

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

Recall #:
99225
Lot/product code:
All Lots; GTIN# 18032568866636;
Recalling firm:
Orthofix U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2026

ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

ALL 50 STATES
▸Full report

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

Recall #:
99192
Lot/product code:
UDI/DI +M335400011, Serial Numbers: 60000316, 60000363, 60000375, 60000388, 60000428, 60000451, 60000469, 60000495, 60000529, 60000569, 60000580, 60000637, 60000643, 60000647, 60000652, 60000668, 60000670, 60000689, 60000692, 60000695, 60000703, 60000706, 60000710, 60000712, 60000716, 60000718, 60000724, 60000726, 60000754, 60000757, 60000759, 60000765, 60000775, 60000776, 60000781, 60000790, 60000793, 60000801, 60000805, 60000816, 60000830, 60000835, 60000850, 60000857, 60000860, 60000879, 60000883, 60000886, 60000899, 60000903, 60000909, 60000916, 60000917, 60000920, 60000927, 60000933, 60000938, 60000939, 60000942, 60000944, 60000948, 60000951, 60000954, 60000959, 60000960, 60000964, 60000966, 60000967, 60000980, 60000985, 60000987, 60000988, 60000990, 60001007, 60001008, 60001013, 60001028, 60001030, 60001031, 60001034, 60001035, 60001036, 60001037, 60001038, 60001039, 60001040, 60001041, 60001042, 60001043, 60001044, 60001045, 60001047, 60001048, 60001049, 60001050, 60001051, 60001052, 60001053, 60001054, 60001055, 60001056, 60001057, 60001058, 60001060, 60001061, 60001062, 60001063, 60001064, 60001065, 60001066, 60001067, 60001068, 60001069, 60001070, 60001071, 60001072, 60001073, 60001074, 60001075, 60001076, 60001077, 60001078, 60001079, 60001080, 60001081, 60001082, 60001083, 60001084, 60001085, 60001086, 60001087, 60001088, 60001089, 60001090, 60001091, 60001092, 60001093, 60001094, 60001095, 60001096, 60001097, 60001098, 60001099, 60001100, 60001101, 60001102, 60001103, 60001104, 60001105, 60001106, 60001107, 60001108, 60001109, 60001110, 60001111, 60001112, 60001113, 60001114, 60001115, 60001116, 60001117, 60001118, 60001119, 60001120, 60001121, 60001122, 60001123, 60001124, 60001125, 60001126, 60001127, 60001128, 60001129, 60001130, 60001131, 60001132, 60001133, 60001134, 60001135, 60001136, 60001138, 60001139, 60001140, 60001142, 60001143, 60001144, 60001145, 60001146, 60001147, 60001148, 60001149, 60001150, 60001151, 60001152, 60001153, 60001154, 60001155, 60001157, 60001158, 60001159, 60001160, 60001161, 60001162, 60001163, 60001164, 60001165, 60001166, 60001167, 60001168, 60001169, 60001170, 60001171, 60001172, 60001173, 60001174, 60001175, 60001176, 60001177, 60001178, 60001179, 60001180, 60001181, 60001182, 60001183, 60001184, 60001185, 60001186, 60001187, 60001188, 60001189, 60001190, 60001191, 60001192, 60001193, 60001194, 60001195, 60001196, 60001197, 60001198, 60001199, 60001200, 60001201, 60001202, 60001203, 60001204, 60001205, 60001206, 60001207, 60001208, 60001209, 60001210, 60001211, 60001212, 60001213, 60001214, 60001215, 60001216, 60001217, 60001218, 60001219, 60001220, 60001221, 60001222, 60001223, 60001224, 60001225, 60001226, 60001227, 60001228, 60001229, 60001230, 60001231, 60001232, 60001233, 60001236, 60001237, 60001238, 60001240, 60001243, 60001245, 60001252, 60001253, 60001255, 60001262, 60001266, 60001271, 60001280, 60001285, 60001286, 60001291, 60001293, 60001295, 60001296, 60001297, 60001300, 60001302, 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600… (truncated, 50626 characters total — see the official FDA record for the full value)
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 10, 2026

IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.

Not guaranteed to be germ-free:

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-0653-2026
Lot/product code:
Lot # 004L24A, Exp Date: 02/19/2027.
Recalling firm:
ACCORD BIOPHARMA INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2026

Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

AZCACOCTFLGAIDILINLAMDMIMOMSMTNCNYOHORSCSDTXUTVAWAWI
▸Full report

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

Recall #:
99225
Lot/product code:
All Lots; GTIN# 18032568866711
Recalling firm:
Orthofix U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2026

ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

ALL 50 STATES
▸Full report

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

Recall #:
99192
Lot/product code:
1) UDI/DI +M335400021, Serial Numbers: 50003704, 50003710, 50004046, 50004072, 50004149, 50004154, 50004156, 50004163, 50004166, 50004168, 50004177, 50004183, 50004205, 50004218, 50004220, 50004249, 50004258, 50004262, 50004263, 50004264, 50004271, 50004300, 50004303, 50004304, 50004305, 50004307, 50004308, 50004310, 50004312, 50004314, 50004316, 50004318, 50004319, 50004323, 50004324, 50004325, 50004326, 50004328, 50004330, 50004331, 50004332, 50004333, 50004334, 50004335, 50004336, 50004338, 50004339, 50004340, 50004341, 50004342, 50004344, 50004345, 50004346, 50004347, 50004348, 50004349, 50004350, 50004351, 50004352, 50004356, 50004358, 50004359, 50004361, 50004363, 50004365, 50004366, 50004370, 50004372, 50004373, 50004374, 50004376, 50004380, 50004382, 50004383, 50004384, 50004385, 50004386, 50004387, 50004389, 50004390, 50004391, 50004392, 50004393, 50004394, 50004395, 50004396, 50004398, 50004399, 50004401, 50004403, 50004405, 50004407, 50004409, 50004410, 50004411, 50004413, 50004415, 50004416, 50004417, 50004424, 50004425, 50004426, 50004428, 50004431, 50004433, 50004435, 50004436, 50004438, 50004439, 50004442, 50004443, 50004444, 50004445, 50004448, 50004449, 50004451, 50004452, 50004455, 50004458, 50004460, 50004461, 50004462, 50004464, 50004465, 50004467, 50004468, 50004469, 50004471, 50004472, 50004473, 50004474, 50004477, 50004481, 50004482, 50004486, 50004487, 50004493, 50004495, 50004499, 50004501, 50004502, 50004506, 50004510, 50004512, 50004513, 50004515, 50004519, 50004521, 50004522, 50004541, 50004552, 50004553, 50004558, 50004559, 50004561, 50004570, 50004571, 50004576, 50004578, 50004579, 50004581, 50004583, 50004586, 50004593, 50004595, 50004599, 50004605, 50004607, 50004608, 50004609, 50004616, 50004631, 50004636, 50004637, 50004642, 50004649, 50004654, 50004655, 50004660, 50004664, 50004665, 50004669, 50004670, 50004671, 50004712, 50004724, 50004756, 50004773, 50004891, 50004907, 50004913, 50004930, 50004939, 50004940, 50005000, 50005001, 50005012, 50005014, 50005018, 50005020, 50005021, 50005027, 50005037, 50005039, 50005040, 50005047, 50005050, 50005057, 50005058, 50005060, 50005065, 50005077, 50005081, 50005096, 50005101, 50005134, 50005184, 50005185, 50005199, 50005205, 50005275, 50005290, 50005328, 50005360, 50005384, 50005425, 50005446, 50005586, 50005594, 50005596, 50005598, 50005599, 50005600, 50005605, 50005607, 50005608, 50005611, 50005615, 50005621, 50005622, 50005623, 50005628, 50005636, 50005637, 50005640, 50005647, 50005648, 50005656, 50005659, 50005660, 50005664, 50005665, 50005666, 50005668, 50005670, 50005671, 50005673, 50005676, 50005683, 50005689, 50005692, 50005695, 50005698, 50005705, 50005706, 50005720, 50005721, 50005722, 50005724, 50005725, 50005726, 50005727, 50005728, 50005735, 50005747, 50005750, 50005752, 50005753, 50005757, 50005758, 50005762, 50005768, 50005770, 50005771, 50005772, 50005775, 50005778, 50005783, 50005785, 50005798, 50005807, 50005808, 50005814, 50005815, 50005823, 50005826, 50005827, 50005829, 50005830, 50005835, 50005843, 50005845, 50005847, 50005848, 50005851, 50005855, 50005856, 50005858, 50005861, 50005863, 50005865, 50005867, 50005868, 50005870, 50005871, 50005879, 50005888, 50005890, 50005891, 50005893, 50005902, 50005910, 50005912, 50005917, 50005920, 50005924, 50005925, 50005927, 50005928, 50005934, 50005935, 50005937, 50005939, 50005941, 50005945, 50005958, 50005962, 50005972, 50005975, 50005977, 50005978, 50005983, 50005987, 50005993, 50006001, 50006006, 50006007, 50006008, 50006010, 50006013, 50006020, 50006031, 50006035, 50006039, 50006045, 50006047, 50006050, 50006060, 50006069, 50006073, 50006083, 50006087, 50006090, 50006108, 50006127, 50006135, 50006149, 50006150, 50006151, 50006159, 50006163, 50006177, 50006183, 50006197, 50006198, 50006205, 50006218, 50006227, 50006230, 50006255, 50006273, 50006288, 50006292, 50006297, 50006303, 50006305, 50006307, 50006311, 50006313, 50006314, 50006315, 50006318, 50006324, 50006335, 50006338, 50006339.50006341, 50006343, 50006367, 50006368, 50006369, 50006371, 50006373, 50006376, 50006377, 50006378, 50006385, 50006389, 50006390, 50006391, 50006394, 50006395, 50006399, 50006401, 50006409, 50006410, 50006413, 50006414, 50006415, 50006416, 50006417, 50006419, 50006428, 50006430, 50006431, 50006432, 50006434, 50006437, 50006441, 50006443, 50006448, 50006453, 50006456, 50006459, 50006461, 50006462, 50006463, 50006465, 50006467, 50006469, 50006475, 50006476, 50006479, 50006480, 50006484, 50006487, 50006489, 50006490, 50006491, 50006492, 50006495, 50006496, 50006499, 50006500, 50006505, 50006506, 50006510, 50006511, 50006516, 50006520, 50006521, 50006525, 50006530, 50006534, 50006535, 50006537, 50006538, 50006539, 50006540, 50006541, 50006546, 50006548, 50006549, 50006553, 50006555, 50006560, 50006562, 50006564, 50006568, 50006570, 50006571, 50006578, 50006579, 50006580, 50006584, 50006591, 50006595, 50006597, 50006601, 50006603, 50006607, 50006608, 50006610, 50006615, 50006617, 50006618, 5… (truncated, 125328 characters total — see the official FDA record for the full value)
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 10, 2026

Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

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

Recall #:
D-0714-2026
Lot/product code:
Lot #: CB0046, Exp. Date 06/2027
Recalling firm:
McKesson
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 10, 2026

Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.

Software issue that can cause an increase in spontaneous software closures.

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

Recall #:
99268
Lot/product code:
Software Version: Protocol Configuration Tool (PCT) v2.0.0; Equipment ID: 100071, 100213, 100355, 102281, 103047, 104154, 104201, 104202, 104204, 104205, 104224, 104503, 104504, 104562, 104885, 105961, 106497, 00016, 00487, 00488, 00489, 00490, 00817, 00491, 00492, 00854, 01173, 01174, 01785, 01337, 01596, 01993.
Recalling firm:
Foundation Medicine, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 9, 2026

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

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

Recall #:
99186
Lot/product code:
Lot Code: Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271125(10)78938271 ; Box (10-Pack) UDI (01)00889024378469(17)271125(10)78938271 ; Individual UDI (01)00889024367173(17)271125(10)78938271 ; Lot Number 78938271 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271126(10)78938272 ; Box (10-Pack) UDI (01)00889024378469(17)271126(10)78938272 ; Individual UDI (01)00889024367173(17)271126(10)78938272 ; Lot Number 78938272 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271127(10)78938273 ; Box (10-Pack) UDI (01)00889024378469(17)271127(10)78938273 ; Individual UDI (01)00889024367173(17)271127(10)78938273 ; Lot Number 78938273 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280206(10)80555986 ; Box (10-Pack) UDI (01)00889024378469(17)280206(10)80555986 ; Individual UDI (01)00889024367173(17)280206(10)80555986 ; Lot Number 80555986 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280102(10)80555987 ; Box (10-Pack) UDI (01)00889024378469(17)280102(10)80555987 ; Individual UDI (01)00889024367173(17)280102(10)80555987 ; Lot Number 80555987 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280210(10)80555988 ; Box (10-Pack) UDI (01)00889024378469(17)280210(10)80555988 ; Individual UDI (01)00889024367173(17)280210(10)80555988 ; Lot Number 80555988 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280214(10)80555989 ; Box (10-Pack) UDI (01)00889024378469(17)280214(10)80555989 ; Individual UDI (01)00889024367173(17)280214(10)80555989 ; Lot Number 80555989 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280217(10)80555990 ; Box (10-Pack) UDI (01)00889024378469(17)280217(10)80555990 ; Individual UDI (01)00889024367173(17)280217(10)80555990 ; Lot Number 80555990 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280225(10)80568849 ; Box (10-Pack) UDI (01)00889024378469(17)280225(10)80568849 ; Individual UDI (01)00889024367173(17)280225(10)80568849 ; Lot Number 80568849 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280409(10)82010858 ; Box (10-Pack) UDI (01)00889024378469(17)280409(10)82010858 ; Individual UDI (01)00889024367173(17)280409(10)82010858 ; Lot Number 82010858 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280403(10)82010859 ; Box (10-Pack) UDI (01)00889024378469(17)280403(10)82010859 ; Individual UDI (01)00889024367173(17)280403(10)82010859 ; Lot Number 82010859 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280415(10)82196691 ; Box (10-Pack) UDI (01)00889024378469(17)280415(10)82196691 ; Individual UDI (01)00889024367173(17)280415(10)82196691 ; Lot Number 82196691 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280419(10)82196692 ; Box (10-Pack) UDI (01)00889024378469(17)280419(10)82196692 ; Individual UDI (01)00889024367173(17)280419(10)82196692 ; Lot Number 82196692 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280423(10)82331021 ; Box (10-Pack) UDI (01)00889024378469(17)280423(10)82331021 ; Individual UDI (01)00889024367173(17)280423(10)82331021 ; Lot Number 82331021 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280427(10)82331022 ; Box (10-Pack) UDI (01)00889024378469(17)280427(10)82331022 ; Individual UDI (01)00889024367173(17)280427(10)82331022 ; Lot Number 82331022 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280501(10)82418900 ; Box (10-Pack) UDI (01)00889024378469(17)280501(10)82418900 ; Individual UDI (01)00889024367173(17)280501(10)82418900 ; Lot Number 82418900 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280507(10)82418901 ; Box (10-Pack) UDI (01)00889024378469(17)280507(10)82418901 ; Individual UDI (01)00889024367173(17)280507(10)82418901 ; Lot Number 82418901 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280513(10)82639501 ; Box (10-Pack) UDI (01)00889024378469(17)280513(10)82639501 ; Individual UDI (01)00889024367173(17)280513(10)82639501 ; Lot Number 82639501 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280516(10)82761025 ; Box (10-Pack) UDI (01)00889024378469(17)280516(10)82761025 ; Individual UDI (01)00889024367173(17)280516(10)82761025 ; Lot Number 82761025 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280529(10)83343102 ; Box (10-Pack) UDI (01)00889024378469(17)280529(10)83343102 ; Individual UDI (01)00889024367173(17)280529(10)83343102 ; Lot Number 83343102 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280820(10)84859541 ; Box (10-Pack) UDI (01)00889024378469(17)280820(10)84859541 ; Individual UDI (01)00889024367173(17)280820(10)84859541 ; Lot Number 84859541 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280902(10)84859542 ; Box (10-Pack) UDI (01)00889024378469(17)280902(10)84859542 ; Individual UDI (01)00889024367… (truncated, 5276 characters total — see the official FDA record for the full value)
Recalling firm:
Zimmer Surgical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 9, 2026

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

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

Recall #:
99186
Lot/product code:
Lot Code: Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)271022(10)79701946 ; Box (10-Pack) UDI (01)00889024380455(17)271022(10)79701946 ; Individual UDI (01)00889024376786(17)271022(10)79701946 ; Lot Number 79701946 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)271028(10)79701947 ; Box (10-Pack) UDI (01)00889024380455(17)271028(10)79701947 ; Individual UDI (01)00889024376786(17)271028(10)79701947 ; Lot Number 79701947 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)271030(10)79701948 ; Box (10-Pack) UDI (01)00889024380455(17)271030(10)79701948 ; Individual UDI (01)00889024376786(17)271030(10)79701948 ; Lot Number 79701948 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280325(10)80555938 ; Box (10-Pack) UDI (01)00889024380455(17)280325(10)80555938 ; Individual UDI (01)00889024376786(17)280325(10)80555938 ; Lot Number 80555938 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280402(10)80555939 ; Box (10-Pack) UDI (01)00889024380455(17)280402(10)80555939 ; Individual UDI (01)00889024376786(17)280402(10)80555939 ; Lot Number 80555939 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280326(10)80555940 ; Box (10-Pack) UDI (01)00889024380455(17)280326(10)80555940 ; Individual UDI (01)00889024376786(17)280326(10)80555940 ; Lot Number 80555940 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280911(10)80581869 ; Box (10-Pack) UDI (01)00889024380455(17)280911(10)80581869 ; Individual UDI (01)00889024376786(17)280911(10)80581869 ; Lot Number 80581869 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280331(10)80581870 ; Box (10-Pack) UDI (01)00889024380455(17)280331(10)80581870 ; Individual UDI (01)00889024376786(17)280331(10)80581870 ; Lot Number 80581870 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280402(10)80765021 ; Box (10-Pack) UDI (01)00889024380455(17)280402(10)80765021 ; Individual UDI (01)00889024376786(17)280402(10)80765021 ; Lot Number 80765021
Recalling firm:
Zimmer Surgical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 9, 2026

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.

Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

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

Recall #:
99280
Lot/product code:
UDI-DI 05060548211226 Model No V-SS-1020 Serial Numbers 66495, 66496 Software Revision Version 62.1 There is no expiry date for this device.
Recalling firm:
CMR SURGICAL LIMITED
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro Spine Pack, Pack Number AMS16313; 5) Lami Kukkar Pack, Pack Number AMS17958; 6) Neuro Pack, Pack Number AMS6452B; 7) Neuro Lami Pack, Pack Number AMS9427C.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

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

Recall #:
99323
Lot/product code:
1) Pack Number AMS12195C, UDI B098AMS12195C0, Lot Numbers: 217757, 222686, 224418, 225587, 227439, 228598, 230569, 234138, 235331, 236869, 238356. 2) Pack Number AMS12195D, UDI B098AMS12195D0, Lot Numbers: 240974. 3) Pack Number AMS12307, UDI B098AMS12307, Lot Numbers: 220948, 234027, 234756, 235909, 238000, 239036, 241680. 4) Pack Number AMS16313, UDI B098AMS163130, Lot Numbers: 241787. 5) Pack Number AMS17958, UDI B098AMS179580, Lot Numbers: 235956, 237474. 6) Pack Number AMS6452B, UDI B098AMS6452B0, Lot Numbers: 212195, 217806, 220779, 222520, 223506, 224581, 225839, 226652, 227717, 233855, 234503, 236416, 240751. 7) Pack Number AMS9427C, UDI B098AMS9427C0, Lot Numbers: 216097, 216766, 217573, 219221, 222013, 222070, 223714, 225092, 226568, 227813, 230393, 231091, 233313, 236502, 238280, 242405.
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4) Spine Pack, Pack Number AMS14991B; 5) Spinal Pack, Pack Number AMS16278; 6) Spine Pack, Pack Number AMS16499; 7) Spine Pack, Pack Number AMS16709; 8) Lumbar Spine Pack, Pack Number AMS17336; 9) Laminectomy Pack, Pack Number AMS17945; 10) Anterior Cervical Pack, Pack Number AMS17946; 11) Spine Pack, Pack Number AMS3150F; 12) Spine Pack, Pack Number AMS3150G; 13) Spine Pack, Pack Number AMS5451D; 14) ENT Pack, Pack Number AMS9771.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

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

Recall #:
99323
Lot/product code:
1) Pack Number AMS13574A, UDI B098AMS13574A0, Lot Numbers: 235911, 236897. 2) Pack Number AMS14710B, UDI B098AMS14710B0, Lot Numbers: 224717, 230666, 213914, 236351. 3) Pack Number AMS14991A, UDI B098AMS14991A0, Lot Numbers: 215450, 230108. 4) Pack Number AMS14991B, UDI B098AMS14991B0, Lot Numbers: 233346. 5) Pack Number AMS16278, UDI B098AMS162780, Lot Numbers: 219872, 222999, 226497, 229309, 236465, 237544, 238613. 6) Pack Number AMS16499, UDI B098AMS164990, Lot Numbers: 215711, 218234, 224253, 226168, 226627, 227667, 228446, 230422, 233097, 233399, 233960, 234577, 234907, 236220, 236852, 237358, 238563, 239114, 240373, 241010, 241717. 7) Pack Number AMS16709, UDI B098AMS167090, Lot Numbers: 223361, 225039, 236666, 240344, 241412. 8) Pack Number AMS17336, UDI B098AMS173360, Lot Numbers: 233541, 240967. 9) Pack Number AMS17945, UDI B098AMS179450, Lot Numbers: 235478, 240779, 241565. 10) Pack Number AMS17946, UDI B098AMS179460, Lot Numbers: 235954, 239092, 241514. 11) Pack Number AMS3150F, UDI B098AMS3150F0, Lot Numbers: 211888, 216076, 216357, 218443, 219827, 221799, 223766, 227324, 228151, 229404, 229717, 230623, 231694, 233211, 234586, 234763, 236581, 241332. 12) Pack Number AMS3150G, UDI B098AMS3150G0, Lot Numbers: 242374. 13) Pack Number AMS5451D, UDI B098AMS5451D0, Lot Numbers: 222621, 224568, 238089, 238575, 242113. 14) Pack Number AMS9771, UDI B098AMS97710, Lot Numbers: 176784, 179837, 181956, 184890, 191784, 194017, 196708, 197543, 199137, 201956, 210134, 215434, 217352, 218696, 225332, 226657, 228224, 228678, 230472, 233592, 235614, 236684, 241927.
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4) HIP CDS-LF, Medline kit SKU CDS984556L; 5) HIP CDS-LF, Medline kit SKU CDS984556M; 6) TOTAL KNEE PACK, Medline kit SKU DYNJ905162Q.

The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.

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

Recall #:
99297
Lot/product code:
Medline kit SKU CDSOPT590T, UDI/DI 10195327555009 (each) 40195327555000 (case), Kit Lot Number 24GDA740; Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 26EDA279; Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 26BDB734; Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 26ADA474; Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 25LDA001; Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 25KDB325; Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 25GDB517; Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 25FDB017; Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 25DDA155; Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 24LDA248; Medline kit SKU CDS983930J, UDI/DI 10193489512298 (each) 40193489512299 (case), Kit Lot Number 25KBL209; Medline kit SKU CDS984556L, UDI/DI 10195327554996 (each) 40195327554997 (case), Kit Lot Number 24JDC180; Medline kit SKU CDS984556L, UDI/DI 10195327554996 (each) 40195327554997 (case), Kit Lot Number 24HDA321; Medline kit SKU CDS984556M, UDI/DI 10198459180248 (each) 40198459180249 (case), Kit Lot Number 25ADB327; Medline kit SKU DYNJ905162Q, UDI/DI 10198459235900 (each) 40198459235901 (case), Kit Lot Number 26CBD346; Medline kit SKU DYNJ905162Q, UDI/DI 10198459235900 (each) 40198459235901 (case), Kit Lot Number 25KBU219.
Recalling firm:
Medline Industries, LP
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UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

A product error defect may cause incorrect bracket placement.

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

Recall #:
99277
Lot/product code:
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
Recalling firm:
Klowen Braces
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UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N

The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.

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

Recall #:
99297
Lot/product code:
UDI/DI 10198459266621 (each) 40198459266622 (case), Lot Numbers: 26EDA285, 26DDA718, 26BDB740, 26ADB079, 26ADA161, 25KDB472, 25GDA213.
Recalling firm:
Medline Industries, LP
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UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

ARTIS icono ceiling. Model Number: 11328100.

Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

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

Recall #:
99224
Lot/product code:
Model Number: 11328100. UDI-DI: 4056869295923.
Recalling firm:
Siemens Medical Solutions USA, Inc
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Class IIModerate risk
DrugRecalled June 8, 2026

Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.

Not guaranteed to be germ-free

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

Recall #:
D-0659-2026
Lot/product code:
Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028.
Recalling firm:
Asclemed USA Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

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

Recall #:
99301
Lot/product code:
DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710
Recalling firm:
Medline Industries, LP
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