BIGNOPE
Ko-fi

Recalls affecting Puerto Rico

Data last updated: September 10, 2026 at 1:16 PM UTC

16,258 recalls found
NewOld
High RiskLow Risk
AllClear

Just announced

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

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

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

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

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

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

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IIModerate risk
DrugRecalled February 13, 2026

Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

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-0379-2026
Lot/product code:
Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027
Recalling firm:
Harbin Jixianglong Biotech Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

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

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 640G Insulin Pump: 643169999763, 763000002763, 763000002671, 643169999770, 763000002886, 643169729353, 763000002657, 763000002688, 763000002664, 763000002749, 763000002817, 763000002787, 763000002800, 763000002756, 763000002848, 763000002794, 763000002695, 763000002725, 763000002701, 763000002633, 763000002862, 643169729360, 763000002879, 763000002824, 763000002732, 763000002640, 763000002770, 763000002855, 763000002718, 763000002831, 763000065195, 763000065201, 763000083441, 763000015510, 763000015541, 763000015480, 763000015589, 763000015497, 763000068998, 763000015381, 763000015435, 763000015336, 763000015367, 763000069001, 763000015374, 763000015398, 763000015350, 763000192228, 763000015572, 763000015343, 763000015411, 763000015428, 763000015404, 763000015442, 763000015459, 763000015534, 763000015503, 763000194383, 763000194222, 763000194444, 763000194390, 763000194239, 763000198596, 763000194406, 763000194369, 763000015596, 763000194277, 763000194666, 763000194352, 763000198602, 763000192211, 763000194451, 763000015565, 763000194246, 763000194338, 763000194307, 763000194475, 763000194314, 763000155346, 763000194468, 763000194437, 763000194376, 763000194345, 763000194253, 763000194260, 763000194413, 763000194420, 763000192136, 763000192143, 763000165246, 763000165307, 763000165130, 643169629813, 763000194321, 763000194291, 763000165147, 763000165277, 763000165222, 763000165116, 763000165123, 763000165185, 763000165154, 763000165314, 763000165338, 763000165260, 763000165093, 763000165284, 763000165215, 763000165109, 763000165345, 763000258337, 763000258344, 763000317140, 763000319274, 763000319540, 763000319618, 763000317089, 763000319489, 763000319533, 763000319380, 763000319366, 763000319267, 763000319298, 763000319304, 763000319236, 763000319328, 763000319571, 763000319229, 763000319281, 763000319311, 763000319588, 763000319519, 763000319243, 763000347536, 763000319427, 763000404567, 763000319557, 763000319564, 763000319410, 763000319526, 763000319434, 763000319595, 763000319373, 763000319397, 763000402686, 763000319441, 763000319359, 763000319496, 763000319458, 763000404550, 763000402693, 763000317188, 763000317102, 763000317119, 763000319342, 763000402709, 763000317195, 763000367039, 763000367046, 763000317157, 643169554931, 643169554948, 643169554917, 643169629691, 643169554955, 643169629677, 643169629653, 643169629684, 643169554924, 643169629660, 643169596429, 643169521049, 643169596405, 643169521315, 643169522138, 643169577664, 643169577688, 643169577695, 643169596368, 643169596382, 643169521865, 643169596443, 643169520882, 643169662544, 643169672239, 643169672246, 643169672260, 643169672277, 643169672253, 643169662582, 643169682672, 643169662551, 643169662568, 643169681972, 643169662575, 643169683211, 643169682405, 643169682139, 643169682788, 643169682245, 643169739468, 643169739451, 643169739482, 643169739444, 643169739512, 643169739475, 643169682948, 643169999800, 643169721289, 643169668874, 643169999787, 763000115968, 763000013066, 763000074814, 763000074821, 763000192204, 763000192198, 763000253288, 763000324704, 763000324698, 763000324681, 00763000115968: MINIMED 640G SYSTEM USER GUIDE(MP6025958-116 1, MP6025958-393 1, M052248C002 1, M052249C002 1).
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled February 13, 2026

Rosabella brand MORINGA; DIETARY SUPPLEMENT CAPSULES; 60 capsules per bottle; Distributed by: Ambrosia Brands, LLC, 625 Randall Ave, St. 100, Cheyenne, WY 82001; SUGGESTED USE: As a dietary supplement, take two (2) veggie capsules once a day. For best results, take 20-30 min before a meal with an 8oz. glass of water or as directed by your health professional; UPC: 8 60012 16172 0

Product may be contaminated with Salmonella

ALL 50 STATES
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0546-2026
Lot/product code:
Lot # - Expiration Date: 5020591 - 03/2027 5020592 - 03/2027 5020593 - 03/2027 5020594 - 03/2027 5020595 - 03/2027 5020596 - 03/2027 5030246 - 04/2027 5030247 - 04/2027 5030248 - 04/2027 5030249 - 04/2027 5030250 - 04/2027 5030251 - 04/2027 5040270 - 05/2027 5040271 - 05/2027 5040272 - 05/2027 5040273 - 05/2027 5040274 - 05/2027 5040275 - 05/2027 5040276 - 05/2027 5040277 - 05/2027 5040278 - 05/2027 5040279 - 05/2027 5050053 - 6/2027 5050054 - 6/2027 5050055 - 6/2027 5050056 - 6/2027 5060069 - 07/2027 5060070 - 07/2027 5060071 - 07/2027 5060072 - 07/2027 5060073 - 07/2027 5060074 - 07/2027 5060075 - 07/2027 5060076 - 07/2027 5060077 - 07/2027 5060078 - 07/2027 5060079 - 07/2027 5060080 - 07/2027 5080084 - 9/2027 5080085 - 9/2027 5080086 - 9/2027 5090107 - 10/2027 5090108 - 10/2027 5090109 - 10/2027 5090113 - 10/2027 5090114 - 10/2027 5090115 - 10/2027 5090116 - 10/2027 5090117 - 10/2027 5090118 - 10/2027 5100039 - 11/2027 5100048 - 11/2027
Recalling firm:
Ambrosia Brands LLC
Resolved:
August 13, 2026
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

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

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Real-Time Revel Insulin Pump: 00613994951502, 00763000161262, 00613994743930, 00643169077737, 00613994904485, 00643169202399, 00643169151369, 00643169478602, 00643169513914, 00643169933170, 00763000161132, 00643169464520: Artwork, CRB D Process, Paradigm REAL-Time Revel Insulin Pump UG (MP6025306-011A 1); Artwork, CRB D Process, Instr, X23 revel, EN (MP6025306-019 1)
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

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

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 670G Insulin Pump: 643169946057, 763000096984, 763000090203, 763000165468, 763000190460, 763000190453, 763000216481, 763000187422, 763000187415, 763000165413, 763000165475, 763000367657, 763000289065, 763000264710, 763000283476, 763000283544, 763000283520, 763000283445, 763000393786, 763000289058, 763000374532, 763000283537, 763000365899, 763000371937, 763000283513, 763000165451, 763000165420, 763000165444, 763000165437, 763000165499, 763000165482, 763000165536, 763000165512, 763000165550, 763000165529, 763000235772, 763000165505, 763000235765, 763000165543, 763000257309, 763000283568, 763000283599, 763000289041, 763000289089, 763000289195, 763000289072, 763000289119, 763000289188, 763000289133, 763000289126, 763000289171, 763000289102, 763000404543, 763000289096, 763000289164, 763000404536, 763000324797, 763000264727, 763000324780, 763000283551, 763000283582, 763000374518, 763000374525, 763000374556, 763000374624, 763000374594, 763000374600, 763000399849, 763000399856, 763000408916, 763000408947, 763000371944, 763000365905, 763000374587, 763000408930, 763000283575, 763000157463, 763000203313, 763000252076, 763000283506, 763000411787, 643169946057, 763000096984, 763000190453, 763000283445, 763000395858, 763000278427, 763000090203, 763000283513, 763000365882, 763000283506, 76300028351303, 763000393786, 76300028351301, 763000166526, 643169939202, 763000190460, 763000283520, 763000072537, 763000256821, 643169939219, 763000187415, 763000283568: MiniMed670G System User Guide(M979513A011 1); MINIMED 630G and MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1); MINIMED 670G SYSTEM USER GUIDE(M988666A021 1, M979513A011 1, M985214A021 1, M985214A261 1, M974439A181 1, M974439A062 1, M974439A032 1, M974439A043 1, M974439A073 1, M974439A103 1, M974439A052 1, M020098C001 3, M020098C003 1, M974439A165 1, M974439A093 1, M974439A083 1); MINIMED 670G SYSTEM USER GUIDE mg/dL(M974449A111 1, M974449A073 1, M974449A103 1, M974449A023 1, M974449A093 1, M974449A083 1, M974449A113 1); MINIMED 670G SYSTEM USER GUIDE mmol/L(M974439A024 1).
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

Probes may rupture/burst during activation

ALL 50 STATES
▸Full report

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

Recall #:
98429
Lot/product code:
UDI: 04050147021822/Expanded Lots: WO472495 WO472496 WO472497 WO472612 WO472613 WO472614 WO473666 WO473667 WO473668 WO473669 WO473670 WO473791 WO476977 WO476978 WO476979 WO476980 WO477011 WO477012 WO477031 WO477511 WO477512 WO477661 WO477662 WO477663 WO477664 WO478276 WO478277 WO478278 WO478279 WO478313 WO478845 WO478846 WO479954 WO479955 WO479956 WO480079; Initial Lots: WO459860 WO462187 WO462322 WO462390 WO462391 WO462392 WO462393 WO462396 WO462677 WO462678 WO463323 WO463324 WO463325 WO463326 WO463386 WO463387 WO464280 WO464281 WO464282 WO464283 WO464284 WO465059 WO465060 WO465061 WO465062 WO467876 WO467877 WO467878 WO467879 WO468225 WO468226 WO468227 WO468642 WO468643 WO468644 WO468645 WO468647 WO468671 WO468672 WO468673 WO468674 WO469361 WO469362 WO469363 W2459858 W2459958 W2462283 W2463593 W2465596 W2465623 W2465693 W2465768 W2468859 W2470050 W2470051 W2470052 W4465597
Recalling firm:
Erbe USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

ALL 50 STATES
▸Full report

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

Recall #:
98371
Lot/product code:
Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

Probes may rupture/burst during activation

ALL 50 STATES
▸Full report

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

Recall #:
98429
Lot/product code:
UDI: 04050147021846/ Expanded Lots:WO472498 WO472499 WO472615 WO472616 WO473794 WO473795 WO474908 WO474909 WO474910 WO475357 WO475358 WO477030 WO477513 WO477514 WO478643 WO478646 WO478647 WO478648 WO478843 WO478844;Initial Lots: WO461840 WO461846 WO462097 W2462284 WO463327 WO463328 WO463388 W2463594 WO464285 WO464286 WO465063 WO465064 W4465351 W2465601 W2465689 W2465749 W2465769 WO467873 WO467874 WO467875 WO468648 WO468649 WO469364 W2459861 W2459862 W2459863
Recalling firm:
Erbe USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

ALL 50 STATES
▸Full report

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

Recall #:
98371
Lot/product code:
Model Number: MAJ-1444. UDI-DI: 04953170355929. Catalog number: N5363530. All Lot/Serial Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled February 12, 2026

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80

Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.

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-0343-2026
Lot/product code:
All lots within expiry
Recalling firm:
Slate Run Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

ALL 50 STATES
▸Full report

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

Recall #:
98371
Lot/product code:
Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use

Probes may rupture/burst during activation

ALL 50 STATES
▸Full report

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

Recall #:
98429
Lot/product code:
UDI: 04050147021785/ Expanded Lots: WO471345 WO471346 WO471347 WO471348 WO471349 WO472537 WO472538 WO472539 WO472540 WO472594 WO472595 WO472596 WO472597 WO472598 WO472599 WO472600 WO472601 WO472602 WO472603 WO472617 WO472618 WO472619 WO472620 WO472621 WO472622 WO472623 WO472624 WO472625 WO472626 WO472627 WO472628 WO472629 WO472630 WO472631 WO472632 WO472633 WO472634 WO472635 WO472636 WO472642 WO472643 WO472644 WO472647 WO472648 WO472649 WO473613 WO473614 WO473615 WO473616 WO473617 WO473618 WO473619 WO473646 WO473647 WO473648 WO473649 WO473650 WO473651 WO474289 WO474290 WO474291 WO474292 WO474580 WO474581 WO474582 WO474583 WO474584 WO474585 WO474586 WO474587 WO474588 WO475359 WO475360 WO475361 WO475362 WO475363 WO475364 WO475368 WO475369 WO475370 WO475371 WO475372 WO475373 WO475374 WO475375 WO475376 WO475377 WO475378 WO475382 WO475383 WO475384 WO475385 WO475386 WO476017 WO476018 WO476019 WO476020 WO476021 WO476226 WO476227 WO476228 WO476229 WO476230 WO476231 WO476232 WO476233 WO476234 WO476235 WO476273 WO476274 WO476275 WO476690 WO476691 WO476692 WO476693 WO476694 WO476695 WO476696 WO476697 WO476698 WO477070 WO477071 WO477072 WO477073 WO477497 WO477498 WO477499 WO477500 WO477501 WO477502 WO477503 WO477504 WO477505 WO477506 WO477507 WO477508 WO477686 WO477687 WO477688 WO477689 WO477979 WO477980 WO477981 WO477982 WO477983 WO477984 WO477985 WO477986 WO477987 WO477988 WO477989 WO477990 WO478178 WO478179 WO478180 WO478181 WO478182 WO478183 WO478184 WO478185 WO478186 WO478187 WO478188 WO478952 WO478953 WO478954 WO478955 WO478957 Initial Lots: WO461310 WO461311 WO461312 WO461314 WO461315 WO461829 WO461831 WO461832 WO461833 WO461834 WO461835 WO461842 WO461843 WO461844 WO461847 WO461848 WO462117 WO462118 WO462119 WO462120 WO462121 WO462122 WO462123 WO462124 WO462125 WO462128 WO462129 WO462130 WO462373 WO462374 WO462375 WO462376 WO462377 WO462378 WO462379 WO462380 WO462387 WO462388 WO462389 WO462397 WO462825 WO462826 WO462827 WO462828 WO462829 WO462830 WO462831 WO462838 WO462839 WO462840 WO462841 WO462842 WO462843 WO462844 WO462845 WO462846 WO462847 WO462848 WO462849 WO463308 WO463309 WO463310 WO463311 WO463312 WO463313 WO463314 WO463316 WO463317 WO463390 WO463391 WO463392 WO463393 WO463394 WO463395 WO463396 WO463397 WO463398 WO463399 WO463400 WO463401 WO463402 WO463403 WO463404 WO463405 WO463406 WO463407 WO463408 WO463409 WO464270 WO464271 WO464272 WO464273 WO464274 WO464275 WO464276 WO464277 WO464278 WO464279 WO464699 WO464700 WO464701 WO464702 WO464703 WO464994 WO464995 WO464996 WO464997 WO465021 WO465022 WO465023 WO465024 WO465025 WO465026 WO465027 WO465050 WO465051 WO465052 WO465053 WO465054 WO465055 WO465056 WO465057 WO465066 WO465067 WO465068 WO465069 WO465243 WO465244 WO465245 WO465246 WO465247 WO465248 WO465249 WO465255 WO465256 WO465257 WO465258 WO465259 WO465260 WO465261 WO465262 WO465266 WO465267 WO465268 WO465269 WO467858 WO467859 WO467860 WO467861 WO467862 WO467863 WO467884 WO467885 WO467886 WO468210 WO468211 WO468212 WO468213 WO468214 WO468215 WO468216 WO468217 WO468218 WO468219 WO468220 WO468221 WO468230 WO468231 WO468232 WO468609 WO468610 WO468611 WO468612 WO468613 WO468614 WO468618 WO468619 WO468620 WO468621 WO468622 WO468623 WO468624 WO468625 WO468626 WO468627 WO468628 WO468629 WO468630 WO468631 WO468632 WO468634 WO468635 WO468636 WO468637 WO468638 WO468639 WO468640 WO468641 WO468654 WO468655 WO468656 WO468657 WO468658 WO468659 WO468660 WO468661 WO468662 WO468663 WO468664 WO468665 WO468666 WO468669 WO468670 WO469350 WO469351 WO469352 WO469353 WO469354 WO469357 WO469358 WO469359 WO471335 WO471336 WO471337 WO471338 WO471339 WO471340 WO471341 WO471342 WO471344 W4468495 W4465348 W2469080 W2469062 W2469061 W2469059 W2469058 W2468858 W2465755 W2465609 W2463595 W2463592 W2463591 W2463590 W2463589 W2462285 W2462282 W2462281 W2462280 W2462279 W2459857 W2459856 W2459855
Recalling firm:
Erbe USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2026

Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

ALL 50 STATES
▸Full report

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

Recall #:
98371
Lot/product code:
Model Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. All Lot/Serial Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Blockers.

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8BLOCKER1; UDI-DI (Product Code): 00840331272895 (BLOCKER8-R8BLOCKER1). 2. Model Number: R8BLOCKER2; UDI-DI (Product Code): 00840331272901 (BLOCKER8-R8BLOCKER2). 3. Model Number: R8BLOCKER3; UDI-DI (Product Code): 00840331272918 (BLOCKER8-R8BLOCKER3). 4. Model Number: R8BLOCKER4; UDI-DI (Product Code): 00840331272932 (BLOCKER8-R8BLOCKER4). 5. Model Number: R8BLOCKER5; UDI-DI (Product Code): 00840331272949 (BLOCKER8-R8BLOCKER5). 6. Model Number: R8BLOCKER6; UDI-DI (Product Code): 00840331272956 (BLOCKER8-R8BLOCKER6). 7. Model Number: S8BLOCKER1; UDI-DI (Product Code): 00840331272963 (BLOCKER8-S8BLOCKER1). 8. Model Number: S8BLOCKER2; UDI-DI (Product Code): 00840331272970 (BLOCKER8-S8BLOCKER2). 9. Model Number: S8BLOCKER3; UDI-DI (Product Code): 00840331272987 (BLOCKER8-S8BLOCKER3). 10. Model Number: U8BLOCKER1; UDI-DI (Product Code): 00840331273038 (BLOCKER8-U8BLOCKER1).
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Frontal Aprons

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8F17; UDI-DI (Product Code): 00840331297706 (FRONTALC18-C8F17-2XM ), 00840331297706 (FRONTALC8-C8F17-LF ), 00840331297706 (FRONTALC8-C8F17-LM ), 00840331297706 (FRONTALC8-C8F17-MF ), 00840331297706 (FRONTALC8-C8F17-MM ), 00840331297706 (FRONTALC8-C8F17-SF ), 00840331297706 (FRONTALC8-C8F17-SM ), 00840331297706 (FRONTALC8-C8F17-XLM ), 00840331297706 (FRONTALC8-C8F17-XSF ), 00840331297706 (FRONTALT18-C8F17-LM ), 00840331297706 (FRONTALT18-C8F17-MM ), 00840331297706 (FRONTALT28-C8F17-3XM ). 2. Model Number: R8601; UDI-DI (Product Code): 00840331258400 (FRONTALC18-R8601-2XF ), 00840331258417 (FRONTALC18-R8601-2XM ), 00840331258448 (FRONTALC8-R8601-LF ), 00840331258455 (FRONTALC8-R8601-LM ), 00840331258462 (FRONTALC8-R8601-MF ), 00840331258479 (FRONTALC8-R8601-MM ), 00840331258486 (FRONTALC8-R8601-PLUS ), 00840331258493 (FRONTALC8-R8601-SF ), 00840331258509 (FRONTALC8-R8601-SM ), 00840331258516 (FRONTALC8-R8601-XLF ), 00840331258523 (FRONTALC8-R8601-XLM ), 00840331270341 (FRONTALT18-R8601-LF ), 00840331270358 (FRONTALT18-R8601-LM ), 00840331270341 (FRONTALT18-R8601-MF ), 00840331270358 (FRONTALT18-R8601-MM ), 00840331270341 (FRONTALT18-R8601-PLUS ), 00840331270341 (FRONTALT18-R8601-SF ), 00840331270358 (FRONTALT18-R8601-SM ), 00840331270358 (FRONTALT18-R8601-XLM ), 00840331270341 (FRONTALT28-R8601-2XF ), 00840331270358 (FRONTALT28-R8601-2XM ), 00840331270358 (FRONTALT28-R8601-3XM ), 00840331270358 (FRONTALT28-R8601-4XM ), None (IFRONTALC8-R8601-2XMR ), None (IFRONTALC8-R8601-LMR ), None (IFRONTALC8-R8601-MFR ), None (IFRONTALC8-R8601-MMR ), None (IFRONTALC8-R8601-SFR ), None (IFRONTALC8-R8601-SMR ), None (IFRONTALC8-R8601-XLMR ), None (IFRONTALC8-R8601-XSFR ), None (IFRONTALC8-R8601-XSMR ), None (IFRONTALC8-R8601-LML ). 3. Model Number: R8A10; UDI-DI (Product Code): 00840331258578 (FRONTALC18-R8A10-2XM ), 00840331258608 (FRONTALC8-R8A10-LF ), 00840331258615 (FRONTALC8-R8A10-LM ), 00840331258622 (FRONTALC8-R8A10-MF ), 00840331258639 (FRONTALC8-R8A10-MM ), 00840331258646 (FRONTALC8-R8A10-PLUS ), 00840331258653 (FRONTALC8-R8A10-SF ), 00840331258660 (FRONTALC8-R8A10-SM ), 00840331258677 (FRONTALC8-R8A10-XLF ), 00840331258684 (FRONTALC8-R8A10-XLM ), 00840331258691 (FRONTALC8-R8A10-XSF ), 00840331258707 (FRONTALC8-R8A10-XSM ), 00840331270280 (FRONTALT18-R8A10-LF ), 00840331270297 (FRONTALT18-R8A10-LM ), 00840331270280 (FRONTALT18-R8A10-MF ), 00840331270297 (FRONTALT18-R8A10-MM ), 00840331270280 (FRONTALT18-R8A10-PLUS ), 00840331270280 (FRONTALT18-R8A10-SF ), 00840331270297 (FRONTALT18-R8A10-SM ), 00840331270297 (FRONTALT18-R8A10-XLM ), 00840331270297 (FRONTALT28-R8A10-2XM ), 00840331270297 (FRONTALT28-R8A10-3XM ), 00840331270297 (FRONTALT28-R8A10-4XM ), 00840331270297 (FRONTALT28-R8A10-5XM ), None (IFRONTALC8-R8A10-LMR ), None (IFRONTALC8-R8A10-MFR ), None (IFRONTALC8-R8A10-MMR ), None (IFRONTALC8-R8A10-XLMR ). 4. Model Number: R8F01; UDI-DI (Product Code): 00840331258899 (FRONTALC18-R8F01-2XM ), 00840331258929 (FRONTALC8-R8F01-LF ), 00840331258936 (FRONTALC8-R8F01-LM ), 00840331258943 (FRONTALC8-R8F01-MF ), 00840331258950 (FRONTALC8-R8F01-MM ), 00840331258936 (FRONTALS8-R8F01-LM ), 00840331258943 (FRONTALS8-R8F01-MF ), 00840331259001 (FRONTALS8-R8F01-XLM ). 5. Model Number: R8F17; UDI-DI (Product Code): 00840331259360 (FRONTALC18-R8F17-2XF ), 00840331259377 (FRONTALC18-R8F17-2XM ), 00840331259384 (FRONTALC18-R8F17-3XF ), 00840331259391 (FRONTALC18-R8F17-3XM ), 00840331259407 (FRONTALC8-R8F17-LF ), 00840331259414 (FRONTALC8-R8F17-LM ), 00840331259421 (FRONTALC8-R8F17-MF ), 00840331259438 (FRONTALC8-R8F17-MM ), 00840331259445 (FRONTALC8-R8F17-PLUS ), 00840331259452 (FRONTALC8-R8F17-SF ), 00840331259469 (FRONTALC8-R8F17-SM ), 00840331259476 (FRONTALC8-R8F17-XLF ), 00840331259483 (FRONTALC8-R8F17-XLM ), 00840331259490 (FRONTALC8-R8F17-XSF ), 00840331259506 (FRONTALC8-R8F17-XSM ), 00840331259407 (FRONTALS8-R8F17-LF ), 00840331259414 (FRONTALS8-R8F17-LM ), 00840331259414 (FRONTALS8-R8F17-MF ), 00840331259438 (FRONTALS8-R8F17-MM ), 00840331259452 (FRONTALS8-R8F17-SF ), 00840331259469 (FRONTALS8-R8F17-SM ), 00840331259476 (FRONTALS8-R8F17-XLF ), 00840331259483 (FRONTALS8-R8F17-XLM ), 00840331259506 (FRONTALS8-R8F17-XSM ), 00840331270228 (FRONTALT18-R8F17-LF ), 00840331270235 (FRONTALT18-R8F17-LM ), 00840331270228 (FRONTALT18-R8F17-MF ), 00840331270235 (FRONTALT18-R8F17-MM ), 00840331270228 (FRONTALT18-R8F17-PLUS ), 00840331270228 (FRONTALT18-R8F17-SF ), 00840331270235 (FRONTALT18-R8F17-SM ), 00840331270228 (FRONTALT18-R8F17-XLF ), 00840331270235 (FRONTALT18-R8F17-XLM ), 00840331270228 (FRONTALT18-R8F17-XSF ), 00840331270235 (FRONTALT18-R8F17-XSM ), 00840331270228 (FRONTALT28-R8F17-2XF ), 00840331270235 (FRONTALT28-R8F17-2XM ), 00840331270228 (FRONTALT28-R8F17-3XF ), 00840331270235 (FRONTALT28-R8F17-3XM ), 00840331270228 (FRONTALT28-R8F17-4XF ), 00840331270235 (FRONTALT28-R8F… (truncated, 12818 characters total — see the official FDA record for the full value)
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

ALL 50 STATES
▸Full report

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

Recall #:
98250
Lot/product code:
Catalog Number: 8015 UDI-DI codes: 10885403210747 10885403210754 10885403210891 10885403212048 10885403222108 10885403224614 10885403515231 10885403516023 10885403519215 10885403519284 10885403519291 10885403801518 10885403801532 10885403801549 Serial Numbers: 12360968 12360983 12360985 12360986 12360987 12360988 12360989 12360990 12360991 12360992 12360993 12360994 12360995 12360996 12360997 12360998 12360999 12361000 12361001 12361002 12361003 12361004 12361005 12361006 12361008 12361010 12361013 12361017 12361018 12361019 12361020 12361021 12361022 12361024 12361026 12361027 12361028 12361029 12361030 12361031 12383470 12383471 12383472 12386884 12386885 12388269 12389653 12389660 12389680 12389683 12389691 12389698 12389715 12389727 12389730 12389734 12389738 12389740 12389741 12390061 12390104 12390107 12390118 12390133 12390155 12390184 12390187 12390199 12390219 12390236 12390239 12390257 12390258 12390271 12390274 12390290 12390293 12390300 12390301 12390302 12390558 12390560 12390578 12390597 12390603 12390619 12390620 12390634 12390635 12390654 12390662 12390666 12390670 12390678 12390701 12390721 12390722 12390729 12390731 12390736 12390738 12393833 12393834 12393836 12393843 12393870 12393916 12393922 12393929 12393953 12393954 12394011 12394012 12394013 12394015 12394040 12394066 12394105 12394106 12394126 12394171 12394179 12394209 12394219 12394222 12394283 12394284 12394290 12394293 12394298 12394301 12394596 12394619 12394643 12394646 12394659 12394672 12394673 12394716 12394745 12394746 12394748 12394780 12394781 12394782 12394783 12394844 12394848 12394849 12394871 12394882 12394912 12394920 12394924 12394925 12394929 12394932 12394937 12395206 12395235 12395236 12395237 12395267 12395268 12395303 12395304 12395305 12395309 12395310 12395336 12395383 12395424 12395432 12395433 12395455 12395457 12395458 12395462 12395474 12395479 12395492 12395507 12395509 12395524 12395546 12395836 12395849 12395856 12395877 12395928 12395933 12395938 12395957 12395971 12395972 12395978 12395983 12395986 12395997 12396041 12396049 12396050 12396051 12396052 12396058 12396070 12396071 12396091 12396099 12396103 12396104 12396105 12396106 12396318 12396334 12396337 12396338 12396458 12396459 12396460 12396461 12396462 12396494 12396495 12396496 12396497 12396498 12396515 12396516 12396517 12396518 12396520 12396619 12396620 12396622 12396623 12396624 12396704 12396705 12396706 12396707 12396763 12396767 12396771 12397039 12397040 12397041 12397042 12397061 12397063 12397077 12397080 12397087 12397088 12397117 12397129 12397138 12397147 12397171 12397177 12397180 12397192 12397195 12397207 12397217 12397218 12397275 12397276 12397282 12397290 12397293 12397307 12397356 12397374 12397375 12397376 12397377 12397378 12397379 12397380 12397403 12397412 12397418 12397420 12397421 12397423 12397426 12397427 12397430 12397680 12397681 12397689 12397690 12397691 12397692 12397726 12397727 12397806 12397807 12397808 12397826 12397827 12397829 12397830 12397833 12397834 12397835 12397848 12397863 12397866 12398135 12398772 12404358 12404359 12404583 12404584 12404586 12404587 12404588 12404595 12404597 12404603 12404605 12404606 12404607 12404608 12404609 12404610 12404789 12404796 12404801 12404802 12404803 12404804 12404863 12404864 12404886 12404887 12404888 12404895 12404897 12404898 12404899 12404900 12404906 12404907 12404908 12404927 12404928 12404930 12404931 12404945 12404953 12404954 12404955 12404977 12404978 12404979 12404980 12404982 12404983 12404996 12405002 12405013 12405019 12405020 12405219 12405220 12405223 12405224 12405231 12405331 12405332 12405337 12405339 12405341 12405513 12405514 12405515 12407888 12418322 12418323 12418324 12418325 12418326 12418332 12418338 12418345 12418352 12418353 12418354 12418360 12418376 12418377 12418378 12418379 12418385 12418386 12418387 12418388 12418389 12418390 12418396 12418397 12418410 12418412 12418419 12418420 12418429 12418432 12418433 12418436 12418437 12418438 12418439 12418440 12418461 12418462 12418463 12418502 12418513 12418514 12418526 12418527 12418528 12418529 12418530 12418552 12418558 12418559 12418562 12418563 12418573 12418574 12418591 12418592 12418593 12418611 12418612 12418613 12418644 12418660 12418666 12418792 12418807 12418808 12418835 12418861 12418862 12418868 12418874 12418885 12418886 12418897 12418903 12418906 12418912 12418913 12418919 12418925 12418927 12418929 12418940 12418941 12418942 12418943 12418949 12418950 12418951 12418957 12418958 12418959 12418965 12418966 12418967 12418968 12418969 12418970 12418981 12418982 12418983 12418984 12418985 12418986 12419006 12419012 12419013 12419014 12419032 12419033 12419034 12419047 12419048 12419059 12419060 12419066 12419082 12419083 12419084 12419096 12419105 12419108 12419118 12419119 12419120 12419121 12419128 12419133 12419145 12419146 12419147 12419148 12419149 12419150 12419151 12419152 12419153 12419164 12419165 12419174 12419177 12419178 12419179 12419180 12419186 12419187 1241… (truncated, 8867432 characters total — see the official FDA record for the full value)
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Protective Sleeves.

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8SL; UDI-DI (Product Code): 00840331271904 (SL8-R8SL). 2. Model Number: R8SL3; UDI-DI (Product Code): 00840331271911 (SL38-R8SL3-LG), 00840331271928 (SL38-R8SL3-MD), 00840331271935 (SL38-R8SL3-SM), 00840186699816 (SL38-R8SL3-XL), 00840331271942 (SL38-R8SL3-XS). 3. Model Number: S8SL; UDI-DI (Product Code): 00840331271959 (SL8-S8SL). 4. Model Number: S8SL3; UDI-DI (Product Code): 00840331271966 (SL38-S8SL3-LG), 00840331271973 (SL38-S8SL3-MD), 00840331271980 (SL38-S8SL3-SM), 00840186699823 (SL38-S8SL3-XL), 00840331271997 (SL38-S8SL3-XS). 5. Model Number: U8SL; UDI-DI (Product Code): 00840331272000 (SL8-U8SL). 6. Model Number: U8SL3; UDI-DI (Product Code): 00840331272017 (SL38-U8SL3-LG), 00840331272024 (SL38-U8SL3-MD), 00840331272031 (SL38-U8SL3-SM), 00840186699830 (SL38-U8SL3-XL), 00840331272048 (SL38-U8SL3-XS).
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

TMJ Bilateral Implants, REF: CHG020

Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

ALL 50 STATES
▸Full report

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

Recall #:
98509
Lot/product code:
UDI-DI: 07613327626575, Lot: 2508181038
Recalling firm:
TMJ Solutions Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Kilt

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8K303; UDI-DI (Product Code): 00840331297638 (FKILTC18-C8K303-2XM, FKILTC8-C8K303-LF, FKILTC8-C8K303-LM, FKILTC8-C8K303-MF, FKILTC8-C8K303-MM, FKILTC8-C8K303-PLUS, FKILTC8-C8K303-SF, FKILTC8-C8K303-SM, FKILTC8-C8K303-XLF, FKILTC8-C8K303-XLM, FKILTC8-C8K303-XSF, FKILTT18-C8K303-LM, FKILTT18-C8K303-MM, FKILTT18-C8K303-PLUS, FKILTT18-C8K303-SM, FKILTT18-C8K303-XLM, FKILTT18-C8K303-XSM, FKILTT28-C8K303-2XM, FKILTT28-C8K303-4XM, FKILTT28-C8K303-5XM). 2. Model Number: R8K303; UDI-DI (Product Code): 00197513003618 (FKILTC18-R8K303-2XF ), 00197513003618 (FKILTC18-R8K303-3XF ), 00197513002932 (FKILTC8-R8K303-LF ), 00197513002925 (FKILTC8-R8K303-LM ), 00197513002918 (FKILTC8-R8K303-MF ), 00197513002901 (FKILTC8-R8K303-MM ), 00197513002888 (FKILTC8-R8K303-SF ), 00197513002871 (FKILTC8-R8K303-SM ), 00197513002864 (FKILTC8-R8K303-XLF ), 00197513000068 (FKILTT18-R8K303-LF ), 00197513000198 (FKILTT18-R8K303-LM ), 00197513000068 (FKILTT18-R8K303-MF ), 00197513000198 (FKILTT18-R8K303-MM ), 00197513000068 (FKILTT18-R8K303-PLUS ), 00197513000068 (FKILTT18-R8K303-SF ), 00197513000198 (FKILTT18-R8K303-SM ), 00197513000068 (FKILTT18-R8K303-XLF ), 00197513000198 (FKILTT18-R8K303-XLM ), 00197513000198 (FKILTT18-R8K303-XSM ), 00197513000068 (FKILTT28-R8K303-2XF ), 00197513000068 (FKILTT28-R8K303-3XF ), 00197513000198 (FKILTT28-R8K303-3XM ), 00197513000068 (FKILTT28-R8K303-4XF ), 00197513000068 (FKILTT38-R8K303-6XF ). 3. Model Number: R8KILT; UDI-DI (Product Code): None (IKILTC8-R8KILT-LMR ), None (IKILTC8-R8KILT-SMR ), 00840331259681 (KILTC18-R8KILT-2XF ), 00840331259698 (KILTC18-R8KILT-2XM ), 00840331259704 (KILTC18-R8KILT-3XF ), 00840331259711 (KILTC18-R8KILT-3XM ), 00840331259728 (KILTC8-R8KILT-LF ), 00840331259735 (KILTC8-R8KILT-LM ), 00840331259735 (KILTC8-R8KILT-MF ), 00840331259759 (KILTC8-R8KILT-MM ), 00840331259766 (KILTC8-R8KILT-PLUS ), 00840331259773 (KILTC8-R8KILT-SF ), 00840331259780 (KILTC8-R8KILT-SM ), 00840331259797 (KILTC8-R8KILT-XLF ), 00840331259803 (KILTC8-R8KILT-XLM ), 00840331259810 (KILTC8-R8KILT-XSF ), 00840331259827 (KILTC8-R8KILT-XSM ), 00840331259728 (KILTS8-R8KILT-LF ), 00840331259735 (KILTS8-R8KILT-LM ), 00840331259742 (KILTS8-R8KILT-MF ), 00840331259759 (KILTS8-R8KILT-MM ), 00840331259766 (KILTS8-R8KILT-PLUS ), 00840331259773 (KILTS8-R8KILT-SF ), 00840331259780 (KILTS8-R8KILT-SM ), 00840331259797 (KILTS8-R8KILT-XLF ), 00840331259803 (KILTS8-R8KILT-XLM ), 00840331269925 (KILTT18-R8KILT-LF ), 00840331269932 (KILTT18-R8KILT-LM ), 00840331269925 (KILTT18-R8KILT-MF ), 00840331269932 (KILTT18-R8KILT-MM ), 00840331269925 (KILTT18-R8KILT-PLUS ), 00840331269925 (KILTT18-R8KILT-SF ), 00840331269932 (KILTT18-R8KILT-SM ), 00840331269925 (KILTT18-R8KILT-XLF ), 00840331269932 (KILTT18-R8KILT-XLM ), 00840331269925 (KILTT18-R8KILT-XSF ), 00840331269932 (KILTT18-R8KILT-XSM ), 00840331269925 (KILTT28-R8KILT-2XF ), 00840331269932 (KILTT28-R8KILT-2XM ), 00840331269925 (KILTT28-R8KILT-3XF ), 00840331269932 (KILTT28-R8KILT-3XM ), 00840331269925 (KILTT28-R8KILT-4XF ), 00840331269932 (KILTT28-R8KILT-4XM ), 00840331269925 (KILTT28-R8KILT-5XF ), 00840331269932 (KILTT28-R8KILT-5XM ), 00840331269925 (KILTT38-R8KILT-6XF ), 00840331269932 (KILTT38-R8KILT-6XM ), 00840331269925 (KILTT38-R8KILT-7XF ), 00840331269932 (KILTT38-R8KILT-7XM ), 00840331269925 (KILTT38-R8KILT-8XF ), 00840331269932 (KILTT38-R8KILT-8XM ), None (IKILTC8-R8KILT-LFL ), None (IKILTC8-R8KILT-LFR ), None (IKILTC8-R8KILT-MFL ), None (IKILTC8-R8KILT-MFR ), None (IKILTC8-R8KILT-MFXL ), None (IKILTC8-R8KILT-MML ), None (IKILTC8-R8KILT-MMR ), None (IKILTC8-R8KILT-SFL ), None (IKILTC8-R8KILT-SML ), None (IKILTC8-R8KILT-XSFR ), None (IKILTC8-R8KILT-2XFL ), None (IKILTC8-R8KILT-2XFR ), None (IKILTC8-R8KILT-3XFR ), None (IKILTC8-R8KILT-LFS ), None (IKILTC8-R8KILT-LML ), None (IKILTC8-R8KILT-LMXL ), None (IKILTC8-R8KILT-MFS ), None (IKILTC8-R8KILT-SFS ), None (IKILTC8-R8KILT-XLMR ), None (IKILTC8-R8KILT-2XMXL ), None (IKILTC8-R8KILT-PLUSL ), None (IKILTC8-R8KILT-SFR ), None (IKILTC8-R8KILT-XLML ), None (IKILTC8-R8KILT-XSFS ), None (IKILTC8-R8KILT-MMXL ), None (IKILTC8-R8KILT-XLMXL ), None (IKILTC8-R8KILT-2XMR ), None (IKILTC8-R8KILT-XSML ), None (IKILTC8-R8KILT-XSMR ), None (IKILTC8-R8KILT-XSMXL ), None (IFKILTC8-R8K303-LFR), None (IFKILTC8-R8K303-MMR). 4. Model Number: R8S302; UDI-DI (Product Code): 00197513004950 (SKIRTWBC8-R8S302-LF ), 00197513004943 (SKIRTWBC8-R8S302-LM ), 00197513004936 (SKIRTWBC8-R8S302-MF ), 00197513004929 (SKIRTWBC8-R8S302-MM ), 00197513004912 (SKIRTWBC8-R8S302-PLUS ), 00197513004905 (SKIRTWBC8-R8S302-SF ), 00197513004899 (SKIRTWBC8-R8S302-SM ), 00197513004875 (SKIRTWBC8-R8S302-XLM ), 00197513000327 (SKIRTWBT18-R8S302-LF ), 00197513000457 (SKIRTWBT18-R8S302-LM ), 00197513000327 (SKIRTWBT18-R8S302-MF ), 00197513000457 (SKIRTWBT18-R8S302-MM ), 00197513000327 (SKIRTWBT18-R8S302-PLUS ), 00197513000457 (SKIR… (truncated, 13128 characters total — see the official FDA record for the full value)
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Half Aprons.

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8HALF1B; UDI-DI (Product Code): 00840331272291 (HALF18-R8HALF1B). 2. Model Number: R8HALF1H; UDI-DI (Product Code): 00840331272314 (HALF18-R8HALF1H). 3. Model Number: R8HALF2B; UDI-DI (Product Code): 00840331272338 (HALF28-R8HALF2B). 4. Model Number: R8HALF2H; UDI-DI (Product Code): 00840331272345 (HALF28-R8HALF2H). 5. Model Number: R8HALF3B; UDI-DI (Product Code): 00840331272352 (HALF38-R8HALF3B). 6. Model Number: R8HALF3H; UDI-DI (Product Code): 00840331272369 (HALF38-R8HALF3H). 7. Model Number: R8HALF4B; UDI-DI (Product Code): 00840331272376 (HALF48-R8HALF4B). 8. Model Number: R8HALF4H; UDI-DI (Product Code): 00840331272383 (HALF48-R8HALF4H). 9. Model Number: R8HALF5B; UDI-DI (Product Code): 00840331272390 (HALF58-R8HALF5B). 10. Model Number: R8HALF5H; UDI-DI (Product Code): 00840331272406 (HALF58-R8HALF5H). 11. Model Number: R8HALF6B; UDI-DI (Product Code): 00840331272420 (HALF68-R8HALF6B). 12. Model Number: R8HALF6H; UDI-DI (Product Code): 00840331272352 (HALF68-R8HALF6H). 13. Model Number: R8HALFSETB; UDI-DI (Product Code): 00840331272413 (HALFSET8-R8HALFSETB). 14. Model Number: R8HALFSETH; UDI-DI (Product Code): 00840331272420 (HALFSET8-R8HALFSETH). 15. Model Number: S8HALF1H; UDI-DI (Product Code): 00840331272451 (HALF18-S8HALF1H). 16. Model Number: S8HALF2B; UDI-DI (Product Code): 00840331272475 (HALF28-S8HALF2B). 17. Model Number: S8HALF2H; UDI-DI (Product Code): 00840331272482 (HALF28-S8HALF2H). 18. Model Number: S8HALF3B; UDI-DI (Product Code): 00840331272499 (HALF38-S8HALF3B). 19. Model Number: S8HALF3H; UDI-DI (Product Code): 00840331272505 (HALF38-S8HALF3H). 20. Model Number: S8HALF4B; UDI-DI (Product Code): 00840331272512 (HALF48-S8HALF4B). 21. Model Number: S8HALF4H; UDI-DI (Product Code): 00840331272529 (HALF48-S8HALF4H). 22. Model Number: S8HALF5B; UDI-DI (Product Code): 00840331272536 (HALF58-S8HALF5B). 23. Model Number: S8HALF5H; UDI-DI (Product Code): 00840331272543 (HALF58-S8HALF5H). 24. Model Number: S8HALF6H; UDI-DI (Product Code): 00840331272499 (HALF68-S8HALF6H). 25. Model Number: S8HALFSETH; UDI-DI (Product Code): 00840331272567 (HALFSET8-S8HALFSETH). 26. Model Number: U8HALF3B; UDI-DI (Product Code): 00840331272635 (HALF38-U8HALF3B). 27. Model Number: U8HALF3H; UDI-DI (Product Code): 00840331272642 (HALF38-U8HALF3H). 28. Model Number: U8HALF4H; UDI-DI (Product Code): 00840331272666 (HALF48-U8HALF4H). 29. Model Number: U8HALF5H; UDI-DI (Product Code): 00840331272680 (HALF58-U8HALF5H). 30. Model Number: U8HALF6H; UDI-DI (Product Code): 00840331272635 (HALF68-U8HALF6H).
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Demi Half Aprons.

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8DHALFR; UDI-DI (Product Code): 00197513001485 (DHALF8-R8DHALFR-L), 00197513001478 (DHALF8-R8DHALFR-M), 00197513001461 (DHALF8-R8DHALFR-S), 00197513001492 (DHALF8-R8DHALFR-XL), 00197513001607 (DHALFSET8-R8DHALFR-SET).
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Kilt Blockers.

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272727 (KILTBLOCKER8-R8KILTBLOCKER10X12). 2. Model Number: R8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011293 (KILTBLOCKER8-R8KILTBLOCKER12X12). 3. Model Number: R8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272741 (KILTBLOCKER8-R8KILTBLOCKER18X20). 4. Model Number: R8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272758 (KILTBLOCKER8-R8KILTBLOCKER20X24). 5. Model Number: R8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272765 (KILTBLOCKER8-R8KILTBLOCKER24X24). 6. Model Number: S8KILTBLOCKER10X10; UDI-DI (Product Code): 00840331272772 (KILTBLOCKER8-S8KILTBLOCKER10X10). 7. Model Number: S8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272789 (KILTBLOCKER8-S8KILTBLOCKER10X12). 8. Model Number: S8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011309 (KILTBLOCKER8-S8KILTBLOCKER12X12). 9. Model Number: S8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272802 (KILTBLOCKER8-S8KILTBLOCKER18X20). 10. Model Number: S8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272819 (KILTBLOCKER8-S8KILTBLOCKER20X24). 11. Model Number: S8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272826 (KILTBLOCKER8-S8KILTBLOCKER24X24). 12. Model Number: U8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011316 (KILTBLOCKER8-U8KILTBLOCKER12X12). 13. Model Number: U8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272864 (KILTBLOCKER8-U8KILTBLOCKER18X20). 14. Model Number: U8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272871 (KILTBLOCKER8-U8KILTBLOCKER20X24). 15. Model Number: U8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272888 (KILTBLOCKER8-U8KILTBLOCKER24X24).
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Leg Wraps.

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8LGW1; UDI-DI (Product Code): 00840331272079 (LGW8SET-R8LGW1). 2. Model Number: R8LGW2; UDI-DI (Product Code): 00840331272086 (LGW8SET-R8LGW2). 3. Model Number: R8LGW3; UDI-DI (Product Code): 00840331272055 (LGW8SET-R8LGW3). 4. Model Number: S8LGW1; UDI-DI (Product Code): 00840331272116 (LGW8SET-S8LGW1). 5. Model Number: S8LGW2; UDI-DI (Product Code): 00840331272123 (LGW8SET-S8LGW2). 6. Model Number: S8LGW3; UDI-DI (Product Code): 00840331272093 (LGW8SET-S8LGW3). 7. Model Number: S8LGW4; UDI-DI (Product Code): 00840331272109 (LGW8SET-S8LGW4). 8. Model Number: U8LGW1; UDI-DI (Product Code): 00840331272154 (LGW8SET-U8LGW1). 9. Model Number: U8LGW2; UDI-DI (Product Code): 00840331272161 (LGW8SET-U8LGW2). 10. Model Number: U8LGW4; UDI-DI (Product Code): 00840331272147 (LGW8SET-U8LGW4).
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Caps.

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8CAP; UDI-DI (Product Code): 00840331272185 (CAP8-R8CAP-LG_XL), 00840331272178 (CAP8-R8CAP-SM_MD). 2. Model Number: S8CAP; UDI-DI (Product Code): 00840331272208 (CAP8-S8CAP-LG_XL), 00840331272192 (CAP8-S8CAP-SM_MD). 3.Model Number: U8CAP; UDI-DI (Product Code): 00840331272222 (CAP8-U8CAP-LG_XL), 00840331272215 (CAP8-U8CAP-SM_MD).
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Thyroid Shield.

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8COPEH; UDI-DI (Product Code): 00840331299052 (COPE-R8COPEH-LG). 2. Model Number: R8TSBBB; UDI-DI (Product Code): 00840331260311 (THYROIDSHIELDO8-R8TSBBB-SM). 3. Model Number: R8TSBBN; UDI-DI: 00840331260328; Product Codes: THYROIDSHIELDO8-R8TSBBN-LG, THYROIDSHIELDO8-R8TSBBN-MD, THYROIDSHIELDO8-R8TSBBN-SM. 4. Model Number: R8TSBBR; UDI-DI (Product Code): 00840331260359 (THYROIDSHIELDO8-R8TSBBR-LG), 00840331260366 (THYROIDSHIELDO8-R8TSBBR-MD), 00840331260373 (THYROIDSHIELDO8-R8TSBBR-SM). 5. Model Number: R8TSBBT; UDI-DI (Product Code): 00840331260397 (THYROIDSHIELDO8-R8TSBBT-MD), 00840331260403 (THYROIDSHIELDO8-R8TSBBT-SM). 6. Model Number: R8TSBHB; UDI-DI (Product Code): 00840331295948 (THYROIDSHIELDO8-R8TSBHB-MD), 00840331295955 (THYROIDSHIELDO8-R8TSBHB-SM). 7. Model Number: R8TSBHN; UDI-DI (Product Code): 00840331260427 (THYROIDSHIELDO8-R8TSBHN-MD ), 00840331260434 (THYROIDSHIELDO8-R8TSBHN-SM ). 8. Model Number: R8TSBHR; UDI-DI (Product Code): 00840331260465 (THYROIDSHIELDO8-R8TSBHR-SM ), 00840331260458 (THYROIDSHIELDO8-R8TSBHR-MD ), 00840331260441 (THYROIDSHIELDO8-R8TSBHR-LG ). 9. Model Number: R8TSBHT; UDI-DI (Product Code): 00840331260489 (THYROIDSHIELDO8-R8TSBHT-MD ), 00840331260496 (THYROIDSHIELDO8-R8TSBHT-SM ). 10. Model Number: R8TSBMB; UDI-DI (Product Code): 00840331295979 (THYROIDSHIELDOM8-R8TSBMB-MD ), 00840331295986 (THYROIDSHIELDOM8-R8TSBMB-SM ). 11. Model Number: R8TSBMN; UDI-DI (Product Code): 00840331260519 (THYROIDSHIELDOM8-R8TSBMN-MD ). 12. Model Number: R8TSBMR; UDI-DI (Product Code): 00840331260533 (THYROIDSHIELDOM8-R8TSBMR-LG ), 00840331260540 (THYROIDSHIELDOM8-R8TSBMR-MD ), 00840331260557 (THYROIDSHIELDOM8-R8TSBMR-SM ). 13. Model Number: R8TSBMT; UDI-DI (Product Code): 00840331260571 (THYROIDSHIELDOM8-R8TSBMT-MD ). 14. Model Number: R8TSCBB; UDI-DI (Product Code): 00840331270525 (THYROIDSHIELD8-R8TSCBB-LG ), 00840331270532 (THYROIDSHIELD8-R8TSCBB-MD ), 00840331270549 (THYROIDSHIELD8-R8TSCBB-SM ). 15. Model Number: R8TSCBN; UDI-DI (Product Code): 00840331260595 (THYROIDSHIELD8-R8TSCBN-LG ), 00840331260601 (THYROIDSHIELD8-R8TSCBN-MD ), 00840331260618 (THYROIDSHIELD8-R8TSCBN-SM ). 16. Model Number: R8TSCBR; UDI-DI (Product Code): 00840331260625 (THYROIDSHIELD8-R8TSCBR-LG ), 00840331260632 (THYROIDSHIELD8-R8TSCBR-MD ), 00840331260649 (THYROIDSHIELD8-R8TSCBR-SM ). 17. Model Number: R8TSCBS; UDI-DI (Product Code): 00840331270594 (THYROIDSHIELD8-R8TSCBS-MD ), 00840331270587 (THYROIDSHIELD8-R8TSCBS-SM ). 18. Model Number: R8TSCBT; UDI-DI (Product Code): 00840331260656 (THYROIDSHIELD8-R8TSCBT-LG ), 00840331260663 (THYROIDSHIELD8-R8TSCBT-MD ), 00840331260670 (THYROIDSHIELD8-R8TSCBT-SM ). 19. Model Number: R8TSCHB; UDI-DI (Product Code): 00840331270495 (THYROIDSHIELD8-R8TSCHB-LG ), 00840331270501 (THYROIDSHIELD8-R8TSCHB-MD ), 00840331270518 (THYROIDSHIELD8-R8TSCHB-SM ). 20. Model Number: R8TSCHN; UDI-DI (Product Code): 00840331260687 (THYROIDSHIELD8-R8TSCHN-LG ), 00840331260694 (THYROIDSHIELD8-R8TSCHN-MD ), 00840331260700 (THYROIDSHIELD8-R8TSCHN-SM ). 21. Model Number: R8TSCHR; UDI-DI (Product Code): 00840331260717 (THYROIDSHIELD8-R8TSCHR-LG ), 00840331260724 (THYROIDSHIELD8-R8TSCHR-MD ), 00840331260731 (THYROIDSHIELD8-R8TSCHR-SM ). 22. Model Number: R8TSCHS; UDI-DI (Product Code): 00840331270563 (THYROIDSHIELD8-R8TSCHS-MD ), 00840331270556 (THYROIDSHIELD8-R8TSCHS-SM ). 23. Model Number: R8TSCHT; UDI-DI (Product Code): 00840331260748 (THYROIDSHIELD8-R8TSCHT-LG ), 00840331260755 (THYROIDSHIELD8-R8TSCHT-MD ), 00840331260762 (THYROIDSHIELD8-R8TSCHT-SM ). 24. Model Number: R8TSCMB; UDI-DI (Product Code): 00840331270464 (THYROIDSHIELDM8-R8TSCMB-LG ), 00840331270471 (THYROIDSHIELDM8-R8TSCMB-MD ), 00840331270488 (THYROIDSHIELDM8-R8TSCMB-SM ). 25. Model Number: R8TSCMN; UDI-DI (Product Code): 00840331260786 (THYROIDSHIELDM8-R8TSCMN-MD ), 00840331260793 (THYROIDSHIELDM8-R8TSCMN-SM ). 26. Model Number: R8TSCMR; UDI-DI (Product Code): 00840331260809 (THYROIDSHIELDM8-R8TSCMR-LG ), 00840331260816 (THYROIDSHIELDM8-R8TSCMR-MD ), 00840331260823 (THYROIDSHIELDM8-R8TSCMR-SM ). 27. Model Number: R8TSCMS; UDI-DI (Product Code): 00840331260830 (THYROIDSHIELDM8-R8TSCMS-MD ), 00840331260847 (THYROIDSHIELDM8-R8TSCMS-SM ). 28. Model Number: R8TSCMT; UDI-DI (Product Code): 00840331260854 (THYROIDSHIELDM8-R8TSCMT-LG ), 00840331260861 (THYROIDSHIELDM8-R8TSCMT-MD ), 00840331260878 (THYROIDSHIELDM8-R8TSCMT-SM ). 29. Model Number: R8TSOBB; UDI-DI (Product Code): 00840331271430 (THYROIDSHIELDO8-R8TSOBB-MD ). 30. Model Number: R8TSOBN; UDI-DI (Product Code): 00840331260892 (THYROIDSHIELDO8-R8TSOBN-MD ). 31. Model Number: R8TSOBR; UDI-DI (Product Code): 00840331260922 (THYROIDSHIELDO8-R8TSOBR-MD ), 00840331260939 (THYROIDSHIELDO8-R8TSOBR-SM ). 32. Model Number: R8TSOHB; UDI-DI (Product Code): 00840331260939 (THYROIDSHIELDO8-R… (truncated, 15279 characters total — see the official FDA record for the full value)
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)