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Recalls affecting Hawaii

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

16,268 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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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 June 11, 2026

ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

ALL 50 STATES
Full report

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

Recall #:
98893
Lot/product code:
Pump Set Code 0052-0038; Introducer Product Code 0052-3052. GTIN: 00813502011708, 00813502012729. All current batches in field.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

ALL 50 STATES
Full report

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

Recall #:
99230
Lot/product code:
GTIN 00810087180126, Serial Numbers: 102174748, 103355157, 103432386, 103480452, 103547915, 103836571, 1-215-0040, 1-226-0123, 1-227-0129, 1-228-0139, 1-22C-0216, 1-234-0276, 1-237-0307, 104015648, 104993721, 1-233-0266, 1-236-0305, 1-237-0307.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 11, 2026

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Not guaranteed to be germ-free: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

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-0647-2026
Lot/product code:
Lot: a) 3194046, Exp. 06/30/2026, 3217036, Exp 07/31/2026, 3279434, Exp 09/30/2026, 3286268, 3304460, Exp 10/31/2026, 3346277, Exp 11/30/2026, 4031686, 4039656, Exp 01/31/2027, 4048949, 4060437, 4067207, Exp 02/28/2027, 4092773, 4094978, 4106623, Exp 03/31/2027, 4120371, 4129596, Exp 04/30/2027, 4144918, Exp 05/31/2027, 4193623 4200771, Exp 06/30/2027, 4227747, 4250845, Exp 08/31/2027, 50872610, 5093809, Exp 03/31/2028, 5121323, Exp 04/30/2028. b) 3331331, Exp 11/30/2026, 4284935, Exp 10/31/2027, 4344682, Exp 11/30/2027, 5015852, Exp 01/31/2028, 5086227, Exp 03/31/2028.
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 11, 2026

BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.

Not guaranteed to be germ-free: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

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-0652-2026
Lot/product code:
Lot: 4190081, Exp 06/30/2027
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 11, 2026

BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Not guaranteed to be germ-free: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

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-0650-2026
Lot/product code:
Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028.
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

ALL 50 STATES
Full report

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

Recall #:
98893
Lot/product code:
Pump Set Code 0052-0023-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011449. All current batches in field.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 11, 2026

ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB

Not guaranteed to be germ-free: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

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-0646-2026
Lot/product code:
Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

ALL 50 STATES
Full report

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

Recall #:
98893
Lot/product code:
Pump Set Code 1000550; Introducer Product Code 0052-3046. GTIN: 00813502013474. All current batches in field.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

IQon Spectral CT IQon Spectral CT Upgrades

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

ALL 50 STATES
Full report

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

Recall #:
99352
Lot/product code:
FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542
Recalling firm:
PHILIPS MEDICAL SYSTEMS
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 11, 2026

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.

Not guaranteed to be germ-free: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

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-0643-2026
Lot/product code:
Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027.
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

ALL 50 STATES
Full report

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

Recall #:
99252
Lot/product code:
UDI-DI: 00191506043131; Lots: CL12695, CL12696, CL12699, CL12700, CL12703, CL12808, CL12816, CL12817, CL12823, CL12834, CL12835, CL12836, CL12853, CL12860, CL12882, CL12883, CL12884, CL12891, CL12907, CL12908, CL12909, CL12919, CL12949, CL12950, CL12969, CL12976, CL12979, CL12980, CL13005, CL13010, CL13011, CL13012, CL13018, CL13032, CL13033, CL13034, CL13037, CL13056, CL13057, CL13058, CL13074, CL13075, CL13076, CL13077, CL13097, CL13098, CL13099, CL13100, CL13104, CL13115, CL13116, CL13117, CL13118, CL13119, CL13135, CL13136, CL13137, CL13138, CL13139, CL13156, CL13157, CL13191, CL13192, CL13193, CL13194, CL13197, CL13208, CL13209, CL13210, CL13215, CL13216, CL13217, CL13224, CL13229, CL13230, CL13257, CL13258, CL13288, CL13289, CL13337, CL13338, CL13365, CL13366, CL13384, CL13398, CL13399, CL13419, CL13420, CL13423, CL13467, CL13469, CL13470, CL13471, CL13472, CL13517, CL13525, CL13526, CL13527, CL13528, CL13535, CL13536, CL13541, CL13550, CL13551, CL13552, CL13553, CL13555, CL13564, CL13565, CL13566, CL13571, CL13574, CL13575, CL13576, CL13598, CL13599, CL13616, CL13637, CL13642, CL13643, CL13644, CL13665, CL13666, CL13667, CL13668, CL13704, CL13705, CL13706, CL13715, CL13716, CL13721, CL13734, CL13735, CL13736, CL13761, CL13762, CL13763, CL13798, CL13799, CL13800, CL13822, CL13825, CL13826, CL13835, CL13836, CL13837, CL13858, CL13859, CL13860, CL13912, CL13913, CL13914, CL13927, CL13928, CL13929, CL13942, CL13944, CL13945, CL13974, CL13975, CL13981, CL13990, CL13991, CL13992, CL14027, CL14028, CL14029, CL14040, CL14041, CL14042, CL14053, CL14054, CL14055, CL14079, CL14080, CL14081, CL14122, CL14123, CL14124, CL14139, CL14140, CL14141, CL14169, CL14172, CL14173, CL14174, CL14188, CL14189, CL14190, CL14227, CL14228, CL14229, CL14250, CL14251, CL14252, CL14288, CL14289, CL14290, CL14347, CL14348, CL14377, CL14378, CL14398, CL14399, CL14400, CL14440, CL14441, CL14442, CL14489, CL14490, CL14492, CL14493, CL14496, CL14502, CL14505, CL14506, CL14520, CL14583, CL14584, CL14585, CL14634, CL14636, CL14637, CL14671, CL14672, CL14673, CL14674, CL14698, CL14699, CL14700, CL14712, CL14713, CL14714, CL14715, CL14751, CL14752, CL14753, CL14771, CL14772, CL14773, CL14774, CL14815, CL14816, CL14817, CL14818, CL14856, CL14857, CL14858, CL14859, CL14872, CL14873, CL14874, CL14930, CL14931, CL14932, CL14936, CL14937, CL14938, CL14970, CL14971, CL14972, CL15006, CL15007, CL15010, CL15011, CL15068, CL15069, CL15070, CL15080, CL15089, CL15110, CL15130, CL15131, CL15132, CL15194, CL15195, CL15196, CL15241, CL15242, CL15243, CL15273, CL15274, CL15275, CL15276, CL15319, CL15320, CL15321, CL15322, CL15359, CL15360, CL15361, CL15362, CL15398, CL15399, CL15400, CL15401, CL15428, CL15429, CL15430, CL15431, CL15451, CL15475, CL15476, CL15477, CL15491, CL15492, CL15493, CL15494, CL15525, CL15540, CL15541, CL15548, CL15549, CL15570, CL15583, CL15584, CL15599, CL15603, CL15617, CL15641, CL15642, CL15718, CL15756, CL15769, CL15770, CL15777
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

ALL 50 STATES
Full report

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

Recall #:
99252
Lot/product code:
UDI-DI: 00191506042516; Lots: CL12917, CL13004, CL13017, CL13046, CL13060, CL13080, CL13103, CL13122, CL13123, CL13142, CL13160, CL13196, CL13212, CL13219, CL13231, CL13260, CL13291, CL13340, CL13375, CL13401, CL13422, CL13468, CL13519, CL13573, CL13578, CL13614, CL13646, CL13670, CL13671, CL13708, CL13719, CL13722, CL13732, CL13760, CL13801, CL13802, CL13820, CL13833, CL13856, CL13910, CL13911, CL13925, CL13940, CL13971, CL13972, CL13988, CL14025, CL14039, CL14050, CL14051, CL14076, CL14077, CL14119, CL14120, CL14135, CL14137, CL14171, CL14187, CL14226, CL14249, CL14286, CL14287, CL14345, CL14346, CL14375, CL14376, CL14396, CL14397, CL14439, CL14488, CL14500, CL14501, CL14518, CL14519, CL14581, CL14582, CL14633, CL14635, CL14670, CL14697, CL14711, CL14749, CL14750, CL14769, CL14770, CL14813, CL14814, CL14854, CL14855, CL14870, CL14871, CL14928, CL14929, CL14933, CL14934, CL14935, CL14968, CL14969, CL15005, CL15009, CL15067, CL15107, CL15108, CL15109, CL15128, CL15129, CL15191, CL15192, CL15193, CL15239, CL15240, CL15272, CL15318, CL15358, CL15397, CL15427, CL15474, CL15490, CL15539, CL15568, CL15569, CL15597, CL15598, CL15637, CL15638, CL15640, CL15754, CL15755, CL15775, CL15776, CL15808
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

ALL 50 STATES
Full report

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

Recall #:
98893
Lot/product code:
Pump Set Code 1000323; introducer Product Code 2000342. GTIN 00813502012811. All current batches in field.
Recalling firm:
Abiomed, Inc.
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

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.

ALL 50 STATES
Full report

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 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)
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.

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-0714-2026
Lot/product code:
Lot #: CB0046, Exp. Date 06/2027
Recalling firm:
McKesson
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

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, 60001303, 60001304, 60001305, 60001306, 60001307, 60001308, 60001309, 60001310, 60001311, 60001312, 60001313, 60001314, 60001315, 60001316, 60001317, 60001318, 60001319, 60001320, 60001321, 60001322, 60001323, 60001324, 60001325, 60001326, 60001327, 60001328, 60001329, 60001330, 60001331, 60001332, 60001333, 60001334, 60001335, 60001336, 60001337, 60001338, 60001339, 60001340, 60001341, 60001342, 60001343, 60001344, 60001345, 60001346, 60001347, 60001348, 60001349, 60001350, 60001351, 60001352, 60001353, 60001354, 60001355, 60001357, 60001358, 60001359, 60001360, 60001361, 60001362, 60001363, 60001364, 60001365, 60001366, 60001367, 60001368, 60001370, 60001371, 60001373, 60001374, 60001375, 60001376, 60001377, 60001378, 60001380, 60001381, 60001382, 60001383, 60001385, 60001386, 60001387, 60001388, 60001390, 60001391, 60001392, 60001393, 60001394, 60001395, 60001396, 60001397, 60001398, 60001400, 60001401, 60001402, 60001403, 60001404, 60001405, 60001406, 60001407, 60001408, 60001409, 60001410, 60001411, 60001413, 60001414, 60001416, 60001417, 60001418, 60001420, 60001421, 60001422, 60001423, 60001424, 60001425, 60001426, 60001427, 60001428, 60001429, 60001430, 60001431, 60001432, 60001433, 60001434, 60001435, 60001436, 60001438, 60001439, 60001443, 60001444, 60001445, 60001446, 60001447, 60001448, 60001449, 60001451, 60001452, 60001453, 60001454, 60001455, 60001456, 60001457, 60001458, 60001459, 60001461, 60001462, 60001463, 60001464, 60001465, 60001466, 60001467, 60001468, 60001469, 60001470, 60001472, 60001473, 60001475, 60001476, 60001477, 60001478, 60001480, 60001481, 60001482, 60001483, 60001484, 60001485, 60001486, 60001487, 60001488, 60001489, 60001490, 60001492, 60001494, 60001495, 60001496, 60001497, 60001498, 60001499, 60001500, 60001501, 60001502, 60001503, 60001504, 60001506, 60001507, 60001508, 60001509, 60001510, 60001511, 60001512, 60001513, 60001514, 60001516, 60001518, 60001519, 60001520, 60001521, 60001522, 60001523, 60001525, 60001526, 60001527, 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)
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)
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.

ALL 50 STATES
Full report

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.

ALL 50 STATES
Full report

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.

ALL 50 STATES
Full report

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

Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G

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.

ALL 50 STATES
Full report

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

Recall #:
99301
Lot/product code:
DYKMBNDL116G UDI-DI 10198459156991 Lots 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105

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.

ALL 50 STATES
Full report

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

Recall #:
99301
Lot/product code:
DYNJT6105 UDI-DI 10198459539381 Lots 25JBM474 25LBS203
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)