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FDA food · drug · device recalls, merged

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

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

Just announced

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

Business Pill, Branch Manager for 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)

Recalls nationwide

Data last updated: September 7, 2026 at 12:15 AM UTC

19,224 recalls found
Wording
Class IIModerate risk
DrugRecalled July 16, 2026

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01

Presence of Particulate Matter: Hair was found in products

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-0728-2026
Lot/product code:
Lot #: 6130235, Exp. Date 02/2027
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Presence of Particulate Matter: Hair was found in products

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-0727-2026
Lot/product code:
Lot #: 6133436, Exp. Date 10/2028
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0737-2026
Lot/product code:
Lot: 25141583, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01

Presence of Particulate Matter: Hair was found in products

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-0726-2026
Lot/product code:
Lot #: 6133801, Exp. Date 01/2028
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2026

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

Full report

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

Recall #:
99445
Lot/product code:
UDI: 06948538363331; 06948538365892 Software Version: G3-2.00.76 Serial Numbers: A3124919140 A3124919145 A3124919181 A3124918105 A3124919105 A3124919148 A3124919131 A3124919151 A3124919130 A3124919147 A3124919153 A3124919126 A3124919149 A3124919144 A3124918225 A3124918400 A3124918379 A3124918407 A3124918228 A3124918390 A3124918398 A3124918268 A3124918260 A3124918341 A3124918259 A3124918285 A3124918251 A3124918464 A3124918255 A3124918257 A3124918261 A3124918172 A3124918267 A3124918266 A3124918280 A3124918212 A3124918269 A3124918382 A3124918271 A3124918130 A3124918246 A3124918525 A3124918282 A3124918528 A3124918294 A3124918362 A3124918529 A3124918358 A3124918374 A3124918516 A3124918364 A3124918509 A3124918511 A3124918366 A3124918385 A3124918372 A3124918376 A3124918263 A3124918512 A3124918380 A3124918287 A3124918085 A3124918300 A3124918297 A3124917180 A3124919172 A3124919058 A3124919054 A3124919116 A3124919057 A3124919189 A3124919112 A3124919115 A3124918327 A3124919100 A3124918197 A3124919120 A3124919191 A3124919186 A3124919118 A3124918115 A3124918317 A3124918429 A3124919137 A3124918153 A3124918207 A3124918069 A3124918323 A3124918023 A3124918136 A3124918070 A3124918081 A3124918134 A3124918051 A3124918114 A3124918283 A3124917222 A3124918182 A3124918030 A3124917146 A3124918037 A3124918180 A3124918185 A3124918169 A3124918042 A3124918183 A3124918056 A3124918166 A3124918038 A3124918163 A3124918448 A3124917327 A3124918160 A3124918444 A3124918124 A3124918441 A3124918107 A3124918256 A3124918119 A3124918128 A3124918450 A3124918447 A3124918123 A3124918112 A3124918431 A3124918293 A3124918440 A3124918428 A3124919087 A3124919008 A3124917075 A3124917345 A3124917393 A3124917129 A3124917305 A3124917059 A3124917277 A3124917070 A3124917103 A3124917061 A3124917308 A3124917385 A3124917376 A3124917392 A3124917156 A3124917133 A3124919185 A3124917055 A3124918032 A3124917144 A3124917391 A3124917151 A3124918168 A3124918325 A3124918164 A3124918120 A3124918439 A3124918044 A3124918449 A3124918031 A3124918446 A3124918161 A3124918125 A3124918158 A3124918109 A3124918433 A3124918435 A3124918443 A3124918116 A3124918286 A3124918281 A3124918302 A3124918388 A3124918111 A3124918434 A3124918118 A3124919063 A3124919104 A3124919070 A3124919069 A3124919064 A3124919175 A3124919174 A3124919159 A3124919061 A3124919044 A3124919075 A3124919095 A3124919080 A3124919073 A3124919088 A3124919055 A3124919125 A3124919187 A3124919124 A3124917150 A3124919081 A3124919188 A3124919089 A3124919121 A3124919195 A3124917074 A3124917314 A3124917262 A3124917066 A3124917072 A3124917145 A3124917387 A3124917058 A3124917123 A3124917403 A3124917400 A3124917263 A3124917386 A3124917397 A3124917261 A3124917054 A3124917382 A3124917264 A3124917244 A3124917187 A3124919060 A3124919035 A3124919076 A3124919119 A3124920166 A3124920156 A3124920159 A3124920142 A3124920148 A3124920205 A3124920130 A3124918202 A3124920114 A3124920123 A3124920189 A3124920194 A3124918363 A3124920167 A3124918159 A3124918034 A3124918233 A3124920136 A3124920129 A3124918104 A3124920145 A3124920171 A3124920122 A3124920149 A3124918432 A3124920188 A3124920198 A3124920204 A3124920195 A3124920192 A3124920185 A3124918348 A3124920200 A3124918299 A3124920143 A3124920160 A3124918291 A3124918292 A3124920147 A3124918526 A3124920138 A3124918151 A3124918521 A3124918284 A3124918520 A3124918370 A3124918320 A3124918354 A3124918359 A3124918391 A3124919052 A3124918373 A3124918510 A3124918507 A3124918500 A3124918356 A3124918515 A3124918508 A3124918008 A3124918082 A3124918084 A3124918018 A3124918079 A3124918188 A3124918016 A3124918073 A3124918003 A3124918065 A3124918022 A3124918074 A3124918145 A3124918187 A3124918194 A3124918201 A3124918067 A3124918004 A3124918013 A3124918192 A3124918210 A3124918205 A3124918059 A3124918036 A3124918058 A3124918126 A3124918174 A3124918057 A3124918165 A3124918451 A3124918157 A3124918442 A3124918156 A3124918430 A3124918108 A3124918110 A3124918296 A3124918106 A3124918288 A3124918438 A3124918127 A3124918171 A3124917057 A3124918436 A3124917278 A3124917157 A3124918301 A3124919166 A3124918121 A3124918445 A3124919096 A3124918113 A3124919050 A3124919168 A3124919059 A3124919183 A3124919025 A3124917389 A3124918368 A3124918295 A3124918355 A3124918117 A3124921241 A3124921561 A3124921334 A3124921551 A3124921556 A3124921555 A3124921346 A3124921249 A3124921330 A3124921340 A3124921250 A3124921062 A3124921089 A3124921040 A3124921034 A3124921265 A3124921268 A3124921039 A3124921273 A3124921041 A3124921064 A3124921070 A3124921065 A3124921083 A3124921035 A3124921047 A3124921032 A3124921066 A3124921266 A3124921081 A3124921050 A3124921044 A3124921042 A3124921053 A3124922067 A3124922179 A3124922082 A3124922127 A3124922050 A3124922095 A3124922061 A3124922059 A3124922064 A3124922073 A3124922055 A3124922109 A3124922074 A3124922119 A3124922115 A3124922078 A3124922090 A3124922043 A3124922093 A3124922035 A3124922041 A3124922037 A3124922125 A3124922105 A3124922038 A3124918011 A3124918010 A3124918020 A3124918017 A3124918007 A312491802… (truncated, 242001 characters total — see the official FDA record for the full value)
Recalling firm:
BMC Medical Co., Ltd.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 15, 2026

Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01.

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0713-2026
Lot/product code:
Lot: 070126X1, Exp. 12/31/2027.
Recalling firm:
Asclemed USA Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2026

Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers

A software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

ALL 50 STATES
Full report

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

Recall #:
99436
Lot/product code:
1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2026

Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers

A software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

ALL 50 STATES
Full report

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

Recall #:
99436
Lot/product code:
1) Part Number C63522, UDI/DI 14987666545089; 2) Part Number C63521, UDI/DI 14987666545072; 3) Part Number C13252, UDI/DI 15099590742331.
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Suture Cinch Long 1pk. Endoscopic tissue approximation device.

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

ALL 50 STATES
Full report

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

Recall #:
99435
Lot/product code:
Material No. M00505550; GTIN: 00191506049188; Lot No. 35903543, 35948104, 35948105, 35976434, 35976435, 35976436, 36023412, 36054695, 36083619, 36116489, 36124315, 36138740, 36222818, 36222819, 36222960, 36231427, 36232903, 36238318, 36291083, 36298791, 36346089, 36346101, 36376494, 36390167, 36411916, 36428532, 36432020, 36443931, 36444025, 36453238, 36472920, 36472938, 36618380, 36624306, 36634952, 36646601, 36724691, 36846026, 36855626, 37019759, 37019868, 37031959, 37073352, 37086263, 37096406, 37108084, 37116726, 37124788, 37126750, 37128111, 37302211, 37399016, 37533710, 37586915, 37604205, 37663465, 38587149,38598199, 38823176, 38833088, 39053113, 39091844; Exp. Date Range: 26-Feb-2028 to 14-Apr-2029.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1

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-0719-2026
Lot/product code:
Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1

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-0715-2026
Lot/product code:
Lot #: 3H1V, Exp. Date 2026/07; 3J1V, 3J2V, Exp. Date 2026/09; 3K1V, Exp. Date 2026/10; 4A1V, 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, Exp. Date 2027/01; 4G1V, 4G2V, 4G3V, Exp. Date 2027/06; 4I1V, 4I2V, 4I2VA Exp. Date 2027/08; 4J1V, 4J2V, Exp. Date 2027/09; 4K2V, 4K3V, 4K4V Exp. Date2027/10; 5B1V, 5B2V, 5B3V, Exp. Date 2028/01; 5D1V, Exp. Date 2028/03; 5E1V, 5E2V, 5E3V, Exp. Date 2028/04; 5H1V, Exp. Date 2028/07; 5I1V, Exp. Date 2028/08; 5J1V, 5J2V, Exp. Date 2028/09; 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V,Exp. Date 2028/11; 6A1V, 6A2V, Exp. Date 2028/12; 6B1V, Exp. Date 2029/01 & Lot 6C1V, Exp. Date 2029/02.
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1

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-0722-2026
Lot/product code:
Lot #: 3J1V, Exp. Date 2026/09; 4A1V, Exp. Date 2026/12; 4G1V, 4G2V, Exp. Date 2027/06; 4I1V, Exp. Date 2027/08; 4JIV, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12 ; 5B1V, Exp. Date 2028/01; 5F1V, Exp. Date 2028/05; 5F1VA, Exp. Date 2028/05; 5H1V & 5H1VA, Exp. Date 2028/07; 5J1V, 5J1VA, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6B1V, Exp. Date 2029/01.
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

ALL 50 STATES
Full report

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

Recall #:
99435
Lot/product code:
Material No. M00505530; GTIN: 00191506060046; Lot No. 36159783, 36179248, 36179249, 36179250, 36179674, 36181153, 36193585, 36195262, 36195281,36213130, 36213131, 36222433, 36223110, 36233350, 36233423, 36233424, 36238771, 36246477, 36247744, 36247745, 36257144, 36257145, 36264795, 36266604, 36285303, 36285304, 36291094, 36291142, 36296642, 36297718, 36298785, 36299374, 36307286, 36335098, 36336245, 36336246, 36336247, 36336248, 36336249, 36349543, 36358240, 36366410, 36368880, 36370038, 36376493, 36390716, 36400755, 36413832, 36429438, 36440653, 36440659, 36440798, 36441070, 36441390, 36443933, 36450076, 36451398, 36452061, 36454608, 36454861, 36461432, 36466525, 36472307, 36472448, 36472813, 36473087, 36475081, 36482317, 36482413, 36482837, 36482838, 36486869, 36488822, 36496658, 36498004, 36500343, 36500745, 36508877, 36509436, 36511012, 36519283, 36519622, 36564120, 36567088, 36567089, 36651483, 36651990, 36660007, 36670672, 36689082, 36691535, 36691536, 36692473, 36715146, 36715947, 36722429, 36733894, 36736063, 36737026, 36742475, 36747253, 36754086, 36756476, 36767158, 36770136, 36795290, 36802913, 36816032, 36816864, 36819466, 36829515, 36837613, 36840422, 36855429, 36859432, 36870323, 36884519, 36886399, 36887192, 36894183, 36906859, 37049911, 37053262, 37063221, 37071091, 37082225, 37256930, 37258435, 37265997, 37268058, 37276648, 37277853, 37332709, 37335148, 37341879, 37431423, 37462817, 37475144, 37479080, 37512600, 37516705, 37538409, 37614916, 37628854, 37701281, 37712590, 37747392, 37759135, 37768422, 37780435, 37804241, 37813732, 37824328, 37846636, 37861753, 37874884, 37906665, 37952534, 37976914, 37980916, 37987576, 38001581, 38020339, 38045267, 38055953, 38064514, 38087625, 38092029, 38119620, 38134479, 38149599, 38168976, 38265895, 38274202, 38277823, 38298897, 38307807, 38355532, 38404637, 38421970, 38438020, 38441891, 38448572, 38458999, 38480821, 38495024, 38498977, 38505659, 38526386, 38527090, 38540408, 38613546, 38620724, 38629370, 38672064, 38682255, 38692722, 38709195, 38711985, 38728857, 38738005, 38748320, 38759951, 38771565, 38787506, 38798542, 38808911, 38847193, 38866237, 38886764, 38917596, 38926776, 38936218, 38939941, 38948809, 39018825, 39029561, 39032429, 39043147, 39095582, 39114250, 39131778; Exp. Dat Range 25-Mar-2028 to 19-Apr-2029.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) 21-4720B, UDI-DI: 10888439934663(each), 50888439934661(case), Lot Number: 94970 ; 2) 21-4720C, UDI-DI: 10197106675793(each), 50197106675791(case), Lot Number: 10339 ; 3) 21-4720C, UDI-DI: 10197106675793(each), 50197106675791(case), Lot Number: 10586 ; 4) PECGMLBOB, UDI-DI: 10197106067406(each), 50197106067404(case), Lot Number: 4366 ; 5) PECGNAAU8, UDI-DI: 10197106967706(each), 50197106967704(case), Lot Number: 12206 ; 6) PECGNAAUJ, UDI-DI: 10197106894514(each), 50197106894512(case), Lot Number: 11851 ; 7) PN1DTSLH9, UDI-DI: 10198956120051(each), 50198956120059(case), Lot Number: 14813 ; 8) PN1DTSLH9, UDI-DI: 10198956120051(each), 50198956120059(case), Lot Number: 14039 ; 9) PN1DTSLHC, UDI-DI: 10197106492222(each), 50197106492220(case), Lot Number: 8160-1 ; 10) PN1DTSLHC, UDI-DI: 10197106492222(each), 50197106492220(case), Lot Number: 3747 ; 11) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10392 ; 12) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10392 ; 13) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 14) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 15) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 16) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 12641 ; 17) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 13289 ; 18) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 19) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 20) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 21) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 22) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10586 ; 23) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11851 ; 24) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 12641 ; 25) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-4 ; 26) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: N/A ; 27) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-5 ; 28) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-7 ; 29) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15192 ; 30) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15192 ; 31) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463 ; 32) PN21OTMC6, UDI-DI: 10195594763718(each), 50195594763716(case), Lot Number: 3024 ; 33) PN21OTMC7, UDI-DI: 10197106267660(each), 50197106267668(case), Lot Number: 6033 ; 34) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 4730 ; 35) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 93845 ; 36) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3024 ; 37) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-1 ; 38) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-2 ; 39) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-3 ; 40) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7390 ; 41) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7390-1 ; 42) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7748 ; 43) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7784-1 ; 44) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 8160-1 ; 45) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7784-2 ; 46) PN21OTMCD, UD… (truncated, 83479 characters total — see the official FDA record for the full value)
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2

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-0717-2026
Lot/product code:
Lot #: 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09; 4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02.
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).

Failed Impurities/Degradation Specifications

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-0741-2026
Lot/product code:
Lot # 506033, Exp Date: 11/30/2026.
Recalling firm:
Precision Dose Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile

Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

ALL 50 STATES
Full report

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

Recall #:
99498
Lot/product code:
UDI:10845854042472, Lot number 1513167
Recalling firm:
ConMed Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-1
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 14039 ; 2) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 3) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 4) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14039 ; 5) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192-1 ; 6) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-5 ; 7) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 8) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 9) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14813 ; 10) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192 ; 11) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-1 ; 12) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-6 ; 13) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-7 ; 14) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-1 ; 15) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 6033 ; 16) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160-2 ; 17) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 10392 ; 18) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-2 ; 19) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 11020 ; 20) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1 ; 21) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160 ; 22) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101; 3) 82121 Ch12-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82121; 4) 82141 Ch14-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82141; 5) 82084 Ch08 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82084; 6) 82104 Ch10 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82104; 7) 82124 Ch12 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82124; 8) 82144 Ch14-40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82144; 9) 82164 Ch16 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82164; 10) 85124 CH12 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85124; 11) 85144 CH14 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85144; 12) 85164 CH16 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85164.

Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.

ALL 50 STATES
Full report

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

Recall #:
99497
Lot/product code:
SKU/REF 82081, UDI/DI 00610075072354, Lot Numbers: 5F273, 5F283, 5H293, 5J153, 6C313. SKU/REF 82101, UDI/DI 00610075072361, Lot Numbers: 5F283, 5G013, 5K253, 6A303. SKU/REF 82121, UDI/DI 00610075072385, Lot Numbers: 5H283, 5H293, 5K183, 5K193, 5K213, 6A253, 6A263, 6B053. SKU/REF 82141, UDI/DI 00610075072392, Lot Numbers: 5E063, 5E073, 5E083, 5F193, 5F203, 5F213, 5F223, 6B133. SKU/REF 82084, UDI/DI 00610075072408, Lot Numbers: 5E293, 5G213, 5G223, 6A223, 6A213. SKU/REF 82104, UDI/DI 00610075072415, Lot Numbers: 5E293, 5E303, 5G243, 5G253, 5J063, 5J073, 5L153, 6D203, 6E293. SKU/REF 82124, UDI/DI 00610075072422, Lot Numbers: 5E303, 5F033, 5F063, 5F043, 5F053, 5J223, 5J283, 5J243, 5K143, 6A163, 6A153, 6B173, 6B183, 5F073. SKU/REF 82144, UDI/DI 00610075072439, Lot Numbers: 6A163, 5F113, 5F133, 5I073, 5G083, 5E243, 5E253, 5E233, 5F103, 5I123, 5F143, 5E263, 5E273, 5I113, 5E283, 5F123, 5F153, 5G093, 5G183, 5G173, 5I153, 5I133, 5I143, 5I063, 6A173, 6B243, 5I103, 6B223, 6B233, 6B253, 6B263, 6B213, 6C033, 6C043, 6B273, 6C013, 6C023, 6C053, 6B283. SKU/REF 82164, UDI/DI 00610075072446, Lot Numbers: 6A223, 6B183, 5F153, 5F163, 5F183, 5F173, 5G103, 5G143, 5G113, 5G153, 6A233, 6C253, 6C243, 6C223, 6C233, 6D303, 6D293, 6D283. SKU/REF 85124, UDI/DI 00610075097432, Lot Numbers: 5K143, 5K133, 6B193. SKU/REF 85144, UDI/DI 00610075097449, Lot Numbers: 6B263, 6B273, 6C253, 5K133, 5K123, 5K113, 5K053, 5K043, 5K063, 5K073, 6A113, 6A133, 5K103, 6A123, 6A093, 6A103, 6C283, 6C263, 6C273, 6E013. SKU/REF 85164, UDI/DI 00610075097456, Lot Numbers: 6D303, 5K133, 6B193, 6A093, 6C283, 5L053, 5L043, 6A083, 5L193, 6A023, 5L223, 6A053, 6C293.
Recalling firm:
Hollister Ulc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 2) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 3) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 4) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 3747 ; 5) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 4366 ; 6) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 2390 ; 7) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 265098 ; 8) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 7390 ; 9) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 7575 ; 10) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 8160 ; 11) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 12) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 13) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 10339 ; 14) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 15) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 16) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 11020 ; 17) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 10339 ; 18) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 19) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 20) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 21) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8808-1 ; 22) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8808-2 ; 23) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 9243-1 ; 24) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10339 ; 25) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8160 ; 26) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 11020 ; 27) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 28) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 29) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 30) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 12206 ; 31) PE29NSFGP, UDI-DI: 10198956163379(each), 50198956163377(case), Lot Number: 12206 ; 32) PE29NSFGP, UDI-DI: 10198956163379(each), 50198956163377(case), Lot Number: 12206 ; 33) PE33HNCR1, UDI-DI: 10197106715765(each), 50197106715763(case), Lot Number: 10339 ; 34) PE33HNCR2, UDI-DI: 10197106973325(each), 50197106973323(case), Lot Number: 10586 ; 35) PE33HNCR3, UDI-DI: 10197106997628(each), 50197106997626(case), Lot Number: 11020 ; 36) PE33HNCR4, UDI-DI: 10198956051201(each), 50198956051209(case), Lot Number: 10586 ; 37) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 3916 ; 38) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 3916 ; 39) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4366 ; 40) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4730 ; 41) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4869-3 ; 42) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4869-2 ; 43) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4869-1 ; 44) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 7044 ; 45) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 8160 ; 46) PE33HNCRA, UDI… (truncated, 222174 characters total — see the official FDA record for the full value)
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43NEE13; 5) LAMINECTOMY PACK , Catalog Number: SNE43NEE13; 7) LAMINECTOMY PACK , Catalog Number: SNE5CLPB13; 8) PEDI SPINE ROSEVILLE , Catalog Number: SNE69PSKR4; 9) SHUNT PACK , Catalog Number: SNE7CSHY15; 10) SHUNT PACK , Catalog Number: SNE7CSHY16; 11) ENS ORTHO FUSION POSTERIEURE 3, Catalog Number: SOP30ODSCL

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) SEN73NSKCF, UDI-DI: 10888439509304(each), 50888439509302(case), Lot Number: 3024-2 ; 2) SNE30CNOHE, UDI-DI: 10195594506230(each), 50195594506238(case), Lot Number: 93845 ; 3) SNE30CRJGY, UDI-DI: 10195594453992(each), 50195594453990(case), Lot Number: 4730 ; 4) SNE43NEE13, UDI-DI: 10198956470965(each), 50198956470963(case), Lot Number: 14039 ; 5) SNE5CLPB12, UDI-DI: 10197106266687(each), 50197106266685(case), Lot Number: 6033 ; 6) SNE5CLPB12, UDI-DI: 10197106266687(each), 50197106266685(case), Lot Number: 4366 ; 7) SNE5CLPB13, UDI-DI: 10197106328132(each), 50197106328130(case), Lot Number: 7390 ; 8) SNE69PSKR4, UDI-DI: 10197106895580(each), 50197106895588(case), Lot Number: 13673 ; 9) SNE7CSHY15, UDI-DI: 10197106979006(each), 50197106979004(case), Lot Number: 13673 ; 10) SNE7CSHY16, UDI-DI: 10198956026582(each), 50198956026580(case), Lot Number: 14813 ; 11) SOP30ODSCL, UDI-DI: 10197106705599(each), 50197106705597(case), Lot Number: 14813
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 2) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 3) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ;
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1

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-0720-2026
Lot/product code:
Lot #: 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12; 5D1VA, Exp. Date 2028/03; 5G1VA, Exp. Date 2028/06; 512V, 512V, 512VB Exp. Date 2028/08; 5L2VA, 512VB 2028/11.
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 5) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 6) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLAI; 7) KIT, LAMINECTOMY , Catalog Number: PN41LMB10; 8) KIT, LAMINECTOMY , Catalog Number: PN41LMB11; 9) KIT, LAMINECTOMY , Catalog Number: PN41LMB12; 10) KIT, NEURO LAMINECTOMY , Catalog Number: PN41LMBLC; 11) KIT, BAL CRANIOTOMY , Catalog Number: PNCGCRBMF; 12) KIT,LAMINECTOMY NH , Catalog Number: PNOCLNNHB; 13) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA235; 14) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA236; 15) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA237; 63

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 2) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 3) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14039 ; 4) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14039 ; 5) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14813 ; 6) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 7) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 8) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 9) PN36NBCH4, UDI-DI: 10198956129863(each), 50198956129861(case), Lot Number: 14813 ; 10) PN36NBCH5, UDI-DI: 10198956131538(each), 50198956131536(case), Lot Number: 14813 ; 11) PN41ACLA9, UDI-DI: 10197106346105(each), 50197106346103(case), Lot Number: 4869 ; 12) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 4366 ; 13) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 4366 ; 14) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 1726-1 ; 15) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 1726-1 ; 16) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 3024 ; 17) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 3916-1 ; 18) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 7748 ; 19) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8160 ; 20) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8160 ; 21) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8808-2 ; 22) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8808-2 ; 23) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243 ; 24) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243-1 ; 25) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243-1 ; 26) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 11020 ; 27) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12206 ; 28) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12206 ; 29) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12641 ; 30) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13289 ; 31) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 32) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 33) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 34) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 14813 ; 35) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 15192 ; 36) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 15192 ; 37) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 16409 ; 38) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 16409 ; 39) PN41LMB10, UDI-DI: 10197106987032(each), 50197106987030(case), Lot Number: 14039 ; 40) PN41LMB11, UDI-DI: 10198956028685(each), 50198956028683(case), Lot Number: 14039 ; 41) PN41LMB12, UDI-DI: 10198956062870(each), 50198956062878(case), Lot Number: 14039 ; 42) PN41LMBLC, UDI-DI: 10888439949698(each), 50888439949696(case), Lot Number: 93845 ; 43) PNCGCRBMF, UDI-DI: 10197106169964(each), 50197106169962(case), Lot Number: 12206 ; 44) PNCGCRBMF, UDI-DI: 10197106169964(each), 50197106169962(case), Lot Number: 3916-2 ; 45) PNCGCRBMF, UDI-DI: 10197106169964(each), 50197106169962(case), Lot Number: 7748-2 ; 46) PNOCLNNHB,… (truncated, 162707 characters total — see the official FDA record for the full value)
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)