BIGNOPE
Ko-fi

Recalls affecting New York

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

17,381 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 Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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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

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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

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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)

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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

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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

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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.

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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

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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)
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High riskLow riskAll
Wording
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
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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 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)
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

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

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

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)
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, 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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 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 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.

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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 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 8, 2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

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

Recall #:
99214
Lot/product code:
Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
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
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 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
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20

Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.

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

Recall #:
99326
Lot/product code:
UDI: 00763000448844/ Lot: D062531
Recalling firm:
Micro Therapeutics, Inc.
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. PROSTATE ROBOTIC DYNJ901822B

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:
DYNJ901822B UDI-DI 10195327319182 Lots 25KBA955 26CBL889
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12

Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.

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

Recall #:
99326
Lot/product code:
UDI: 00763000448806/ Lot: D062612, D112860
Recalling firm:
Micro Therapeutics, 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) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6) Septoplasty Pack, Part Number AMS13150; 7) Septoplasty Pack, Part Number AMS13150A; 8) Septoplasty Pack, Part Number AMS13150B; 9) Rhinoplasty Pack, Part Number AMS14496A; 10) Rhinoplasty Pack, Part Number AMS14496B; 11) Rhinoplasty Pack, Part Number AMS14496C; 12) Laryngoscopy Pack, Part Number AMS14736; 13) Nasal and Sinus Pack, Part Number AMS16417; 14) Major Pack, Part Number AMS16586; 15) Major Pack, Part Number AMS16586A; 16) Nasal and Sinus Pack, Part Number AMS7619A; 17) Sinus Pack, Part Number AMS7819A.

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 AMS10411B, UDI B098AMS10411B0, Lot Numbers: 219316, 221418, 225796, 227963, 229410, 231465, 232835, 234875, 236009. 2) Pack Number AMS10411C, UDI B098AMS10411C0, Lot Numbers: 237159, 239012. 3) Pack Number AMS11963A, UDI B098AMS11963A0, Lot Numbers: 219232, 221841, 231180, 233233, 235232, 237047, 239415. 4) Pack Number AMS12636C, UDI B098AMS12636C0, Lot Numbers: 216052, 216353, 219607, 222572, 227336, 228169, 232135, 232908, 236235, 242190. 5) Pack Number AMS12731, UDI B098AMS127310, Lot Numbers: 211494, 219640, 224583, 225855, 226678, 228322, 231368, 241824. 6) Pack Number AMS13150, UDI B098AMS131500, Lot Numbers: 172113, 190090, 196504, 197866, 199463, 199844, 201971. 7) Pack Number AMS13150A, UDI B098AMS13150A0, Lot Numbers: 202549, 204081, 209263, 210230, 211511, 213173, 215672. 8) Pack Number AMS13150B, UDI B098AMS13150B0, Lot Numbers: 216273, 216809, 218664, 219473, 222602, 224670, 225793, 227885, 229995, 232849, 234167, 235630, 236695, 237697, 239909, 241667. 9) Pack Number AMS14496A, UDI B098AMS14496A0, Lot Numbers: 207772, 219739. 10) Pack Number AMS14496B, UDI B098AMS14496B0, Lot Numbers: 223681, 224699, 226316, 227598. 11) Pack Number AMS14496C, UDI B098AMS14496C0, Lot Numbers: 231376, 237310. 12) Pack Number AMS14736, UDI B098AMS147360, Lot Numbers: 192735, 204268, 222714, 226621. 13) Pack Number AMS16417, UDI B098AMS164170, Lot Numbers: 217216, 219433, 219463, 229357, 235439, 237701, 241666. 14) Pack Number AMS16586, UDI B098AMS16586, Lot Numbers: 229154, 230255. 15) Pack Number AMS16586A, UDI B098AMS16586A0, Lot Numbers: 233268, 233269, 233688, 233689, 235659, 236978, 237621, 238623, 239249, 241987. 16) Pack Number AMS7619A, UDI B098AMS7619A0, Lot Numbers: 176227, 179354, 184684, 186205, 187036, 188521, 189734, 191564, 195253, 197149, 202475, 202880, 205844, 206922, 210055, 211416, 212266, 215112, 217611, 218240, 219633, 221172, 223315, 225142, 226992, 229948, 231847, 232319, 234276, 235042, 239240, 241617. 17) Pack Number AMS7819A, UDI B098AMS7819A0, Lot Numbers: 173334, 176639, 177152, 180388, 182683, 186406, 190810, 192202, 192848, 194365, 197188, 199488, 202783, 205388, 206750, 211253, 212412, 215250, 216089, 217246, 220359, 223776, 225483, 226654, 229721, 232212, 233317, 233852, 236921, 238278, 242389.
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
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
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

Surgical dressing manufactured not meeting quality requirements (greater thickness).

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

Recall #:
99151
Lot/product code:
Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631
Recalling firm:
ConvaTec, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

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

Recall #:
99340
Lot/product code:
GTIN 07613327061499, Batch Numbers: 24262FG2, 24263FG2, 24264FG2, 24266FG2, 24267FG2, 24268FG2, 24269FG2, 24283FG2, 24284FG2, 24286FG2, 24287FG2, 24288FG2, 24289FG2, 24290FG2, 24291FG2, 24292FG2, 24293FG2, 24294FG2, 24295FG2, 24296FG2, 24298FG2, 24299FG2, 24302FG2, 24303FG2, 24304FG2, 24305FG2, 24306FG2, 24309FG2, 24311FG2, 24312FG2, 24316FG2, 24317FG2, 24318FG2, 24319FG2, 24320FG2, 24321FG2, 24322FG2, 24323FG2, 24324FG2, 24325FG2, 24326FG2, 24337FG2, 24339FG2, 24346FG2, 24347FG2, 24348FG2, 24349FG2, 24350FG2, 24351FG2, 24352FG2, 24353FG2, 24354FG2, 24355FG2, 24356FG2, 24358FG2, 24361FG2, 25007FG2, 25008FG2, 25009FG2, 25010FG2, 25013FG2, 25014FG2, 25017FG2, 25020FG2, 25027FG2, 25028FG2, 25029FG2, 25035FG2, 25036FG2, 25037FG2, 25038FG2, 25041FG2, 25043FG2, 25044FG2, 25045FG2, 25048FG2, 25052FG2, 25055FG2, 25056FG2, 25057FG2, 25058FG2, 25059FG2, 25062FG2, 25063FG2, 25064FG2, 25065FG2, 25069FG2, 25070FG2, 25071FG2, 25073FG2, 25076FG2, 25077FG2, 25078FG2, 25079FG2, 25080FG2, 25084FG2, 25085FG2, 25086FG2, 25087FG2, 25092FG2, 25093FG2, 25094FG2, 25097FG2, 25098FG2, 25099FG2, 25100FG2, 25101FG2, 25107FG2, 25112FG2, 25113FG2, 25114FG2, 25115FG2, 25118FG2, 25119FG2, 25120FG2, 25121FG2, 25122FG2, 25125FG2, 25126FG2, 25134FG2, 25135FG2, 25137FG2, 25139FG2, 25140FG2, 25141FG2, 25142FG2, 25144FG2, 25148FG2, 25155FG2, 25160FG2, 25161FG2, 25162FG2, 25163FG2.
Recalling firm:
Stryker Corporation
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) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.

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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▸Full report

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

Recall #:
99323
Lot/product code:
1) Pack Number AMS12206, UDI B098AMS122060, Lot Numbers: 201002, 205119, 206649, 211870, 215233, 217552, 218967, 219166, 222076, 224914, 227000, 228485, 230336, 231348, 232214, 238290, 239795, 241802. 2) Pack Number AMS15517, UDI B098AMS155170, Lot Numbers: 215924, 218494, 235207, 241105. 3) Pack Number AMS15863A, UDI B098AMS15863A0, Lot Numbers: 229370, 235320, 235699, 237597, 239311, 241458.
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 8, 2026

Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.

Weaker than it should be Drug

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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-0656-2026
Lot/product code:
Lot # D2401522, Exp Date: 06/2026.
Recalling firm:
ACCORD HEALTHCARE, INC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 8, 2026

Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.

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-0658-2026
Lot/product code:
Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, Exp 11/30/2026; AE5052, 041426X2, 041726X1, 051826X2, 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. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M

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:
DYNJ68477L UDI-DI 10198459487866 Lots 25HMF458 25LME235 DYNJ68477M UDI-DI 10198459678738 Lots 26CMK219 26EMG622
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)