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Recalls affecting Connecticut

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

16,745 recalls found

Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸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

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
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UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

ALL 50 STATES
▸Full report

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

Recall #:
99036
Lot/product code:
UDI-DI of service blender component: 00813841020010 Affected devices were installed with the following serial numbers of affected service blender components: 002I08B 002X08B 008S10B 008Y09B 013S09B 016A09B 016R09B 018P10B 019J09B 028C08B 02X08B 033N09B 037E08B 038D10B 038N08B 042F10B 042S10B 042T10B 045808B 045M08B 047I08B 047J08B 054C10B 054I10B 054L10B 054N09B 054O09B 054U10B 055D09B 055V09B 057908B 061K09B 062C10B 068W10B 077M09B 078509B 078M09B 078S09B 084I10B 084J10B 092G08B 099F08B 1 B1405629 100E08B 100R08B 104A09B 12105790 133D08B 136708B 136W08B 141J09B 142009B 142W09B 144J08B 144N08B 149Q09B 163608B 169D08B 169G08B 169H08B 172308B 175P08B 185I08B 185Q08B 186208B 189808B 189A09B 189C08B 189F09B 193L08B 193N08B 195D09B 195E09B 195J09B 195K09B 198H08B 210K09B 210U09B 218N09B 219C09B 219K09B 220E08B 226F08B 244L09B 260X09B 266M08B 267808B 280F09B 281H09B 285J07B 295H09B 295J09B 295P08B 310I09B 338707B 338E07B 338K07B 352Y09B 355P09B 7979700385 B1003093 B1003112 B1003124 B1003140 B1003143 B1003147 B1003153 B1003343 B1003452 B1003550 B1003867 B1003944 B1004844 B1004861 B1004924 B1005029 B1005036 B1005044 B1005422 B1005534 B1005560 B1005571 B1005839 B1006102 B1006113 B1006304 B1006858 B1006935 B1006971 B1007078 B1007220 B1007262 B1007355 B1007360 B1007376 B1007383 B1007528 B1007605 B1101215 B1101224 B1101241 B1101445 B1101446 B1101547 B1101862 B1101869 B1101998 B1102011 B1102015 B1102153 B1102384 B1102405 B1102571 B1103145 B1103159 B1103251 B1103256 B1103422 B1103434 B1103576 B1103710 B1103844 B1103846 B1103850 B1103856 B1103968 B1104440 B1104441 B1104450 B1104651 B1104658 B1104764 B1105179 B1105180 B1105232 B1105244 B1105418 B1105548 B1105806 B1106117 B1106789 B1106804 B1106812 B1106823 B1107074 B1107357 B1107360 B1107581 B1107658 B1201350 B1201361 B1201601 B1201990 B1202187 B1202199 B1202740 B1203408 B1203414 B1203520 B1203557 B1203643 B1203892 B1203905 B1203909 B1203913 B1203917 B1204710 B1205518 B1205537 B1205804 B1205820 B1206201 B1206202 B1206224 B1206632 B1206909 B1206948 B1207178 B1207180 B1207181 B1207189 B1207201 B1207202 B1207215 B1207240 B1207308 B1207331 B1207515 B1207555 B1208045 B1208066 B1208067 B1208068 B1208069 B1208102 B1208104 B1208141 B1208296 B1208702 B1208729 B1208736 B1208739 B1208759 B1208979 B1208989 B1208991 B1209004 B1209089 B1209090 B1209099 B1209175 B1209181 B1209188 B1209197 B1209199 B1209432 B1209463 B1209467 B1209641 B1209642 B1209647 B1209796 B1209805 B1209956 B1211743 B1211784 B1211907 B1211913 B1212670 B1212683 B1212706 B1212817 B1300102 B1300110 B1300126 B1300416 B1300430 B1300445 B1300805 B1300812 B1300830 B1300834 B1300858 B1300919 B1302107 B1302132 B1302133 B1302180 B1302527 B1302530 B1302583 B1302593 B1302945 B1302982 B1302983 B1303084 B1303098 B1303452 B1303453 B1303454 B1303492 B1303581 B1303854 B1303868 B1303910 B1304069 B1304357 B1304374 B1304376 B1304450 B1304518 B1304564 B1304570 B1304574 B1304751 B1305163 B1305175 B1305213 B1305215 B1305337 B1305363 B1305523 B1306031 B1306066 B1306068 B1306078 B1306902 B1307502 B1307507 B1307514 B1307526 B1307553 B1307814 B1307820 B1307878 B1308177 B1308332 B1308340 B1308362 B1308367 B1308874 B1309123 B1309124 B1309135 B1309139 B1309150 B1309158 B1309683 B1309705 B1309706 B1309962 B1310226 B1310237 B1400022 B1400237 B1400243 B1400264 B1400278 B1400292 B1400688 B1400713 B1400760 B1400771 B1400946 B1401337 B1401342 B1401343 B1401757 B1401785 B1401893 B1402142 B1402162 B1402168 B1402196 B1402198 B1402224 B1402504 B1402565 B1402854 B1403053 B1403079 B1403128 B1403140 B1403155 B1403196 B1403216 B1403230 B1403366 B1403732 B1403769 B1403778 B1403880 B1403893 B1403911 B1403914 B1403934 B1403952 B1404215 B1404267 B1404291 B1404430 B1404469 B1404473 B1404480 B1404481 B1404495 B1404723 B1404738 B1404754 B1404760 B1404786 B1404925 B1404981 B1405020 B1405134 B1405213 B1405218 B1405542 B1405544 B1405553 B1405558 B1405574 B1405576 B1405577 B1405589 B1405601 B1405608 B1405621 B1405622 B1405629 B1405630 B1405649 B1405688 B1405909 B1405923 B1405998 B1406104 B1406186 B1406190 B1406191 B1406196 B1406197 B1406432 B1406441 B1406479 B1406482 B1406506 B1406507 B1406518 B1406518-2 B1406528 B1406537 B1406599 B1407065 B1407092 B1407755 B1407776 B1407777 B1407786 B1408337 B1408379 B1408525 B1408533 B1409022 B1409048 B1409051 B1409052 B1409053 B1409324 B1409328 B1409329 B1409366 B1409509 B1409533 B1409546 B1409569 B1409588 B1409590 B1409651 B1409722 B1409731 B1409759 B1501314 B1501349 B1501652 B1501657 B1501675 B1501686 B1501687 B1501693 B1502040 B1502054 B1502157 B1502195 B1502200 B1502616 B1502655 B1502656 B1502659 B1502668 B1502675 B1502822 B1502887 B1502888 B1502892 B1502894 B1502899 B1503153 B1503178 B1503210 B1503224 B1503229 B1503240 B1503274 B1503472 B1503476 B1503500 B1503608 B1503611 B1503644 B1503665 B1503667 B1503673 B1503687 B1503698 B1504073 B1504076 B1504078 B1504339 B1504538 B1504754 B1504755 B1504761 B1504765 B1504800 B1504919 B1504951 B1504999 B1505000 B1505085 B1505090 B1505091 B1505092 B1505093 B1505096 B1505276 B1505301 B1505304 … (truncated, 25337 characters total — see the official FDA record for the full value)
Recalling firm:
Datex-Ohmeda Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.

ALL 50 STATES
▸Full report

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

Recall #:
99042
Lot/product code:
REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
Recalling firm:
GE Medical Systems SCS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000.

BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

ALL 50 STATES
▸Full report

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

Recall #:
99115
Lot/product code:
Lot Code: GEM Premier 7000: Part number: 00000015279 UDI: 0195226000924 Units distributed in US: 4 affected BCR wands on the GEM Premier 7000 in the US. GEM Premier 7000 Serial Nos. 26012062, 26012065, 26012069 and 26012070. Affected Accessory: Bar Code Reader (BCR) Wand Part number: 00024015859 UDI: 08426950869634 Units distributed in US: 4
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes: 00884450529645 00884450529690 00884450529744 REF: MSWSTDS35150 UDI-DI codes: 00884450529690 00884450529744 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 REF: MSWSTFA3580 UDI-DI code: 00884450529515 REF: MSWSTFS35150 UDI-DI code: 00884450529553 The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

Due to unsealed portions of pouches.

ALL 50 STATES
▸Full report

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

Recall #:
98818
Lot/product code:
REF: MSWSTDA35150 UDI-DI code: 00884450529645 Lot Numbers: K3410951 K3420005 K3420006 K3420007 K3420106 UDI-DI code: 00884450529669 Lot Number: K3420005 UDI-DI code: 00884450529690 Lot Number: K3420006 REF: MSWSTDA35180 UDI-DI code: 00884450529645 Lot Number: K3405121 UDI-DI code: 00884450529669 Lot Numbers: K3405121 K3405126 K3405127 K3405128 K3405129 K3405130 K3410953 K3420010 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 Lot Numbers: K3405122 K3410937 K3410958 REF: MSWSTDA3580 UDI-DI code: 00884450529645 Lot Number: K3405257 UDI-DI code: 00884450529690 Lot Number: K3405257 UDI-DI code: 00884450529744 Lot Number: K3405257 REF: MSWSTDS35150 UDI-DI code: 00884450529690 Lot Number: K3420082 UDI-DI code: 00884450529744 Lot Numbers: K3420082 K3420101 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 Lot Number: K3405261 REF: MSWSTFA3580 UDI-DI code: 00884450529515 Lot Number: K3420079 REF: MSWSTFS35150 UDI-DI code: 00884450529553 Lot Number: K3399729
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

ALL 50 STATES
▸Full report

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

Recall #:
99036
Lot/product code:
UDI-DI of service blender component: 00813841020010 Affected devices were installed with the following serial numbers of affected service blender components: 002I08B 002X08B 008S10B 008Y09B 013S09B 016A09B 016R09B 018P10B 019J09B 028C08B 02X08B 033N09B 037E08B 038D10B 038N08B 042F10B 042S10B 042T10B 045808B 045M08B 047I08B 047J08B 054C10B 054I10B 054L10B 054N09B 054O09B 054U10B 055D09B 055V09B 057908B 061K09B 062C10B 068W10B 077M09B 078509B 078M09B 078S09B 084I10B 084J10B 092G08B 099F08B 1 B1405629 100E08B 100R08B 104A09B 12105790 133D08B 136708B 136W08B 141J09B 142009B 142W09B 144J08B 144N08B 149Q09B 163608B 169D08B 169G08B 169H08B 172308B 175P08B 185I08B 185Q08B 186208B 189808B 189A09B 189C08B 189F09B 193L08B 193N08B 195D09B 195E09B 195J09B 195K09B 198H08B 210K09B 210U09B 218N09B 219C09B 219K09B 220E08B 226F08B 244L09B 260X09B 266M08B 267808B 280F09B 281H09B 285J07B 295H09B 295J09B 295P08B 310I09B 338707B 338E07B 338K07B 352Y09B 355P09B 7979700385 B1003093 B1003112 B1003124 B1003140 B1003143 B1003147 B1003153 B1003343 B1003452 B1003550 B1003867 B1003944 B1004844 B1004861 B1004924 B1005029 B1005036 B1005044 B1005422 B1005534 B1005560 B1005571 B1005839 B1006102 B1006113 B1006304 B1006858 B1006935 B1006971 B1007078 B1007220 B1007262 B1007355 B1007360 B1007376 B1007383 B1007528 B1007605 B1101215 B1101224 B1101241 B1101445 B1101446 B1101547 B1101862 B1101869 B1101998 B1102011 B1102015 B1102153 B1102384 B1102405 B1102571 B1103145 B1103159 B1103251 B1103256 B1103422 B1103434 B1103576 B1103710 B1103844 B1103846 B1103850 B1103856 B1103968 B1104440 B1104441 B1104450 B1104651 B1104658 B1104764 B1105179 B1105180 B1105232 B1105244 B1105418 B1105548 B1105806 B1106117 B1106789 B1106804 B1106812 B1106823 B1107074 B1107357 B1107360 B1107581 B1107658 B1201350 B1201361 B1201601 B1201990 B1202187 B1202199 B1202740 B1203408 B1203414 B1203520 B1203557 B1203643 B1203892 B1203905 B1203909 B1203913 B1203917 B1204710 B1205518 B1205537 B1205804 B1205820 B1206201 B1206202 B1206224 B1206632 B1206909 B1206948 B1207178 B1207180 B1207181 B1207189 B1207201 B1207202 B1207215 B1207240 B1207308 B1207331 B1207515 B1207555 B1208045 B1208066 B1208067 B1208068 B1208069 B1208102 B1208104 B1208141 B1208296 B1208702 B1208729 B1208736 B1208739 B1208759 B1208979 B1208989 B1208991 B1209004 B1209089 B1209090 B1209099 B1209175 B1209181 B1209188 B1209197 B1209199 B1209432 B1209463 B1209467 B1209641 B1209642 B1209647 B1209796 B1209805 B1209956 B1211743 B1211784 B1211907 B1211913 B1212670 B1212683 B1212706 B1212817 B1300102 B1300110 B1300126 B1300416 B1300430 B1300445 B1300805 B1300812 B1300830 B1300834 B1300858 B1300919 B1302107 B1302132 B1302133 B1302180 B1302527 B1302530 B1302583 B1302593 B1302945 B1302982 B1302983 B1303084 B1303098 B1303452 B1303453 B1303454 B1303492 B1303581 B1303854 B1303868 B1303910 B1304069 B1304357 B1304374 B1304376 B1304450 B1304518 B1304564 B1304570 B1304574 B1304751 B1305163 B1305175 B1305213 B1305215 B1305337 B1305363 B1305523 B1306031 B1306066 B1306068 B1306078 B1306902 B1307502 B1307507 B1307514 B1307526 B1307553 B1307814 B1307820 B1307878 B1308177 B1308332 B1308340 B1308362 B1308367 B1308874 B1309123 B1309124 B1309135 B1309139 B1309150 B1309158 B1309683 B1309705 B1309706 B1309962 B1310226 B1310237 B1400022 B1400237 B1400243 B1400264 B1400278 B1400292 B1400688 B1400713 B1400760 B1400771 B1400946 B1401337 B1401342 B1401343 B1401757 B1401785 B1401893 B1402142 B1402162 B1402168 B1402196 B1402198 B1402224 B1402504 B1402565 B1402854 B1403053 B1403079 B1403128 B1403140 B1403155 B1403196 B1403216 B1403230 B1403366 B1403732 B1403769 B1403778 B1403880 B1403893 B1403911 B1403914 B1403934 B1403952 B1404215 B1404267 B1404291 B1404430 B1404469 B1404473 B1404480 B1404481 B1404495 B1404723 B1404738 B1404754 B1404760 B1404786 B1404925 B1404981 B1405020 B1405134 B1405213 B1405218 B1405542 B1405544 B1405553 B1405558 B1405574 B1405576 B1405577 B1405589 B1405601 B1405608 B1405621 B1405622 B1405629 B1405630 B1405649 B1405688 B1405909 B1405923 B1405998 B1406104 B1406186 B1406190 B1406191 B1406196 B1406197 B1406432 B1406441 B1406479 B1406482 B1406506 B1406507 B1406518 B1406518-2 B1406528 B1406537 B1406599 B1407065 B1407092 B1407755 B1407776 B1407777 B1407786 B1408337 B1408379 B1408525 B1408533 B1409022 B1409048 B1409051 B1409052 B1409053 B1409324 B1409328 B1409329 B1409366 B1409509 B1409533 B1409546 B1409569 B1409588 B1409590 B1409651 B1409722 B1409731 B1409759 B1501314 B1501349 B1501652 B1501657 B1501675 B1501686 B1501687 B1501693 B1502040 B1502054 B1502157 B1502195 B1502200 B1502616 B1502655 B1502656 B1502659 B1502668 B1502675 B1502822 B1502887 B1502888 B1502892 B1502894 B1502899 B1503153 B1503178 B1503210 B1503224 B1503229 B1503240 B1503274 B1503472 B1503476 B1503500 B1503608 B1503611 B1503644 B1503665 B1503667 B1503673 B1503687 B1503698 B1504073 B1504076 B1504078 B1504339 B1504538 B1504754 B1504755 B1504761 B1504765 B1504800 B1504919 B1504951 B1504999 B1505000 B1505085 B1505090 B1505091 B1505092 B1505093 B1505096 B1505276 B1505301 B1505304 … (truncated, 25337 characters total — see the official FDA record for the full value)
Recalling firm:
Datex-Ohmeda Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system.

BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

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

Recall #:
99115
Lot/product code:
Lot Code: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in US: 0 affected BCR wands on the GEM Premier 5000 in the US. GEM Premier 5000 Serial Nos.: N/A Units distributed in Hong Kong: 27 affected BCR wands on the GEM Premier 5000 in Hong Kong. GEM Premier 5000 Serial Nos.: 20106073, 20106039, 19052933, 20116415, 20064792, 22062065, 22062067, 19103490, 22092716, 22102881, 18112339, 19012518, 20126582, 20075256, 20064794, 20106036, 24016057, 21088758, 21088759, 18061910, 24016081, 24016108, 24108036, 24108044, 24067370, 24067371 and 24077468. Units distributed in United Kingdom: 67 affected BCR wands on the GEM Premier 5000 in the United Kingdom. GEM Premier 5000 Serial Nos.: 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137, 25081799, 25081797, 25091839, 25091840, 25091864, 25091870, 25091868, 25091873, 25091880, 25091876, 25101886, 25101889, 25101887, 25101891, 25101907, 25101904, 25101912, 25101905, 25101917, 25101921, 25101926, 25101929, 25101934, 25101927, 25111968, 25121986, 25121985, 25121981, 25121984, 25121994, 25121995, 25121982, 25121993, 25121991, 25121999, 25121996, 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516 and 22082271. Units distributed in Spain: 21 affected BCR wands on the GEM Premier 5000 in Spain. GEM Premier 5000 Serial Nos.: 25028719, 18021546, 18021549, 26012036, 18051850, 23054764, 21068342, 25080219, 26010781, 25122012, 25041639, 25120558, 25079944, 25079943, 25028719, 25100485, 25079947, 25100483, 25100484, 21057870 and 26010710. Units distributed in Argentina: 3 affected BCR wands on the GEM Premier 5000 in Argentina. GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897. Affected Accessory: Bar Code Reader (BCR) Wand Part number: 00024019255 UDI: 08426950870227 Units distributed in US: 0 Units distributed in Hong Kong: 27 Units distributed in Spain: 21 Units distributed in the United Kingdom: 67 Units distributed in Argentina: 3
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled May 8, 2026

Fly By Jing (branded) Creamy Sesame Noodles; 3.8 oz packets. Sold in single and 4 packs. Single UPC: 8-50052-23988-6 4 pack UPC: 8-50052-23991-6

Possible cross-contamination resulting in not listed on the label allergen ingredient (Peanut)

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

Recall #:
H-0854-2026
Lot/product code:
Lot Codes: Best By Dates: 10-15-2026HJ 10/15/2026 12-06-2026HJ 12/06/2026 10/15/2026HJ 10/15/2026 03/23/2027HJ 03/23/2027
Recalling firm:
Fly By Jing Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.

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

Recall #:
98888
Lot/product code:
REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613
Recalling firm:
Ventec Life Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components

Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.

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

Recall #:
99219
Lot/product code:
Model Number: 109003 UDI-DI code: M9461090030 Model Number: 109004 UDI-DI code: M9461090040
Recalling firm:
Think Surgical, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 8, 2026

cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81.

Not guaranteed to be germ-free

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

Recall #:
D-0546-2026
Lot/product code:
Lot: CVZFW, Exp.:2026-JUL-04; CVZYG, Exp.: 2026-AUG-19; CWSYT, Exp.: 2026-OCT-22; CWDZY, Exp.:2026-NOV-20; CWTSD, Exp.:2026-DEC-11; CVTFK, Exp.:2026-JUL-04; CVTSN, Exp.: 2026-AUG-19; CWVGP. Exp.:2026-DEC-11; CVWXT, CVWXV, CVWXW, Exp.:2026-JUL-04; CWHFF, Exp.: 2026-OCT-22; CWNDS, Exp.: 2026-DEC-11.
Recalling firm:
UCB Biosciences Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

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

Recall #:
99036
Lot/product code:
UDI-DI of service blender component: 00813841020010 Affected devices were installed with the following serial numbers of affected service blender components: 002I08B 002X08B 008S10B 008Y09B 013S09B 016A09B 016R09B 018P10B 019J09B 028C08B 02X08B 033N09B 037E08B 038D10B 038N08B 042F10B 042S10B 042T10B 045808B 045M08B 047I08B 047J08B 054C10B 054I10B 054L10B 054N09B 054O09B 054U10B 055D09B 055V09B 057908B 061K09B 062C10B 068W10B 077M09B 078509B 078M09B 078S09B 084I10B 084J10B 092G08B 099F08B 1 B1405629 100E08B 100R08B 104A09B 12105790 133D08B 136708B 136W08B 141J09B 142009B 142W09B 144J08B 144N08B 149Q09B 163608B 169D08B 169G08B 169H08B 172308B 175P08B 185I08B 185Q08B 186208B 189808B 189A09B 189C08B 189F09B 193L08B 193N08B 195D09B 195E09B 195J09B 195K09B 198H08B 210K09B 210U09B 218N09B 219C09B 219K09B 220E08B 226F08B 244L09B 260X09B 266M08B 267808B 280F09B 281H09B 285J07B 295H09B 295J09B 295P08B 310I09B 338707B 338E07B 338K07B 352Y09B 355P09B 7979700385 B1003093 B1003112 B1003124 B1003140 B1003143 B1003147 B1003153 B1003343 B1003452 B1003550 B1003867 B1003944 B1004844 B1004861 B1004924 B1005029 B1005036 B1005044 B1005422 B1005534 B1005560 B1005571 B1005839 B1006102 B1006113 B1006304 B1006858 B1006935 B1006971 B1007078 B1007220 B1007262 B1007355 B1007360 B1007376 B1007383 B1007528 B1007605 B1101215 B1101224 B1101241 B1101445 B1101446 B1101547 B1101862 B1101869 B1101998 B1102011 B1102015 B1102153 B1102384 B1102405 B1102571 B1103145 B1103159 B1103251 B1103256 B1103422 B1103434 B1103576 B1103710 B1103844 B1103846 B1103850 B1103856 B1103968 B1104440 B1104441 B1104450 B1104651 B1104658 B1104764 B1105179 B1105180 B1105232 B1105244 B1105418 B1105548 B1105806 B1106117 B1106789 B1106804 B1106812 B1106823 B1107074 B1107357 B1107360 B1107581 B1107658 B1201350 B1201361 B1201601 B1201990 B1202187 B1202199 B1202740 B1203408 B1203414 B1203520 B1203557 B1203643 B1203892 B1203905 B1203909 B1203913 B1203917 B1204710 B1205518 B1205537 B1205804 B1205820 B1206201 B1206202 B1206224 B1206632 B1206909 B1206948 B1207178 B1207180 B1207181 B1207189 B1207201 B1207202 B1207215 B1207240 B1207308 B1207331 B1207515 B1207555 B1208045 B1208066 B1208067 B1208068 B1208069 B1208102 B1208104 B1208141 B1208296 B1208702 B1208729 B1208736 B1208739 B1208759 B1208979 B1208989 B1208991 B1209004 B1209089 B1209090 B1209099 B1209175 B1209181 B1209188 B1209197 B1209199 B1209432 B1209463 B1209467 B1209641 B1209642 B1209647 B1209796 B1209805 B1209956 B1211743 B1211784 B1211907 B1211913 B1212670 B1212683 B1212706 B1212817 B1300102 B1300110 B1300126 B1300416 B1300430 B1300445 B1300805 B1300812 B1300830 B1300834 B1300858 B1300919 B1302107 B1302132 B1302133 B1302180 B1302527 B1302530 B1302583 B1302593 B1302945 B1302982 B1302983 B1303084 B1303098 B1303452 B1303453 B1303454 B1303492 B1303581 B1303854 B1303868 B1303910 B1304069 B1304357 B1304374 B1304376 B1304450 B1304518 B1304564 B1304570 B1304574 B1304751 B1305163 B1305175 B1305213 B1305215 B1305337 B1305363 B1305523 B1306031 B1306066 B1306068 B1306078 B1306902 B1307502 B1307507 B1307514 B1307526 B1307553 B1307814 B1307820 B1307878 B1308177 B1308332 B1308340 B1308362 B1308367 B1308874 B1309123 B1309124 B1309135 B1309139 B1309150 B1309158 B1309683 B1309705 B1309706 B1309962 B1310226 B1310237 B1400022 B1400237 B1400243 B1400264 B1400278 B1400292 B1400688 B1400713 B1400760 B1400771 B1400946 B1401337 B1401342 B1401343 B1401757 B1401785 B1401893 B1402142 B1402162 B1402168 B1402196 B1402198 B1402224 B1402504 B1402565 B1402854 B1403053 B1403079 B1403128 B1403140 B1403155 B1403196 B1403216 B1403230 B1403366 B1403732 B1403769 B1403778 B1403880 B1403893 B1403911 B1403914 B1403934 B1403952 B1404215 B1404267 B1404291 B1404430 B1404469 B1404473 B1404480 B1404481 B1404495 B1404723 B1404738 B1404754 B1404760 B1404786 B1404925 B1404981 B1405020 B1405134 B1405213 B1405218 B1405542 B1405544 B1405553 B1405558 B1405574 B1405576 B1405577 B1405589 B1405601 B1405608 B1405621 B1405622 B1405629 B1405630 B1405649 B1405688 B1405909 B1405923 B1405998 B1406104 B1406186 B1406190 B1406191 B1406196 B1406197 B1406432 B1406441 B1406479 B1406482 B1406506 B1406507 B1406518 B1406518-2 B1406528 B1406537 B1406599 B1407065 B1407092 B1407755 B1407776 B1407777 B1407786 B1408337 B1408379 B1408525 B1408533 B1409022 B1409048 B1409051 B1409052 B1409053 B1409324 B1409328 B1409329 B1409366 B1409509 B1409533 B1409546 B1409569 B1409588 B1409590 B1409651 B1409722 B1409731 B1409759 B1501314 B1501349 B1501652 B1501657 B1501675 B1501686 B1501687 B1501693 B1502040 B1502054 B1502157 B1502195 B1502200 B1502616 B1502655 B1502656 B1502659 B1502668 B1502675 B1502822 B1502887 B1502888 B1502892 B1502894 B1502899 B1503153 B1503178 B1503210 B1503224 B1503229 B1503240 B1503274 B1503472 B1503476 B1503500 B1503608 B1503611 B1503644 B1503665 B1503667 B1503673 B1503687 B1503698 B1504073 B1504076 B1504078 B1504339 B1504538 B1504754 B1504755 B1504761 B1504765 B1504800 B1504919 B1504951 B1504999 B1505000 B1505085 B1505090 B1505091 B1505092 B1505093 B1505096 B1505276 B1505301 B1505304 … (truncated, 25337 characters total — see the official FDA record for the full value)
Recalling firm:
Datex-Ohmeda Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.

BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

ALL 50 STATES
▸Full report

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

Recall #:
99115
Lot/product code:
Lot Code: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Hong Kong: 27 affected BCR wands on the GEM Premier 5000 in Hong Kong. GEM Premier 5000 Serial Nos.: 20106073, 20106039, 19052933, 20116415, 20064792, 22062065, 22062067, 19103490, 22092716, 22102881, 18112339, 19012518, 20126582, 20075256, 20064794, 20106036, 24016057, 21088758, 21088759, 18061910, 24016081, 24016108, 24108036, 24108044, 24067370, 24067371 and 24077468. Affected Accessory: Bar Code Reader (BCR) Wand Part number: 00024019255 UDI: 08426950870227 Units distributed in Hong Kong: 27
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.

BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

ALL 50 STATES
▸Full report

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

Recall #:
99115
Lot/product code:
Lot Code: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in United Kingdom: 67 affected BCR wands on the GEM Premier 5000 in the United Kingdom. GEM Premier 5000 Serial Nos.: 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137, 25081799, 25081797, 25091839, 25091840, 25091864, 25091870, 25091868, 25091873, 25091880, 25091876, 25101886, 25101889, 25101887, 25101891, 25101907, 25101904, 25101912, 25101905, 25101917, 25101921, 25101926, 25101929, 25101934, 25101927, 25111968, 25121986, 25121985, 25121981, 25121984, 25121994, 25121995, 25121982, 25121993, 25121991, 25121999, 25121996, 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516 and 22082271. Affected Accessory: Bar Code Reader (BCR) Wand Part number: 00024019255 UDI: 08426950870227 Units distributed in the United Kingdom: 67
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.

BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

ALL 50 STATES
▸Full report

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

Recall #:
99115
Lot/product code:
Lot Code: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Spain: 21 affected BCR wands on the GEM Premier 5000 in Spain. GEM Premier 5000 Serial Nos.: 25028719, 18021546, 18021549, 26012036, 18051850, 23054764, 21068342, 25080219, 26010781, 25122012, 25041639, 25120558, 25079944, 25079943, 25028719, 25100485, 25079947, 25100483, 25100484, 21057870 and 26010710. Affected Accessory: Bar Code Reader (BCR) Wand Part number: 00024019255 UDI: 08426950870227 Units distributed in Spain: 21
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.

BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

ALL 50 STATES
▸Full report

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

Recall #:
99115
Lot/product code:
Lot Code: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Argentina: 3 affected BCR wands on the GEM Premier 5000 in Argentina. GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897. Affected Accessory: Bar Code Reader (BCR) Wand Part number: 00024019255 UDI: 08426950870227 Units distributed in Argentina: 3
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 7, 2026

Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.

Incorrect concentration of Betadine solution contained within certain AVID convenience kits.

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

Recall #:
99249
Lot/product code:
Model/Catalog Number: LVEY27. UDI-DI: 10809160499528. Lot Numbers (Expiration Date): 1680076 (12/31/2026), 1680590 (6/30/2027).
Recalling firm:
AVID Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 7, 2026

3mensio Workstation (Vascular Fenestrated) software

User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information

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

Recall #:
98930
Lot/product code:
Software Version 10.7. UDIs: (01)08056304455925(11)250423(8012)10.7, (01)08056304455925(11)250523(8012)10.7 SP1, (01)08056304455925(11)250714(8012)10.7 SP2, (01)08056304455925(11)250729(8012)10.7 SP3, (01)08056304455925(11)251016(8012)10.7 SP4, (01)08056304455925(11)251103(8012)10.7 SP5
Recalling firm:
PIE Medical Imaging B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 7, 2026

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay

A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.

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

Recall #:
98985
Lot/product code:
Manufacturing Lot/Serial Numbers: FA6254, FA6260, FA6286; UDIs: (01)00842768035425(10)FA6254(17)20260911; (01)00842768035425(10)FA6260(17)20260917; (01)00842768035425(10)FA6286(17)20261013.
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled May 7, 2026

Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A

Due to not meeting quality requirements, or potential not meeting quality requirements, levels of endotoxins

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Recall #:
98962
Lot/product code:
Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 1/2" X-Ray Detectable Catalog Number: 200100 UDI codes: (01)2 4026704 41748 7(17)260521(11)210521(10)21E1485 (01)2 4026704 41748 7(17)260811(11)210811(10)21H2304 (01)2 4026704 41748 7(17)260906(11)210906(10)21H2594 (01)2 4026704 41748 7(17)260906(11)210906(10)21H2595 (01)2 4026704 41748 7(17)261018(11)211018(10)21K3161 (01)2 4026704 41748 7(17)261130(11)211130(10)21L3593 (01)2 4026704 41748 7(17)270203(11)220203(10)22A0175 (01)2 4026704 41748 7(17)270316(11)220316(10)22C0661 (01)2 4026704 41748 7(17)270512(11)220512(10)22E1386 (01)2 4026704 41748 7(17)270915(11)220915(10)22J2777 (01)2 4026704 41748 7(17)271019(11)221019(10)22K3102 (01)2 4026704 41748 7(17)271027(11)221027(10)22K3269 (01)2 4026704 41748 7(17)271031(11)221031(10)22K3270 (01)2 4026704 41748 7(17)280124(11)230124(10)23A0102 (01)2 4026704 41748 7(17)280405(11)230405(10)23D0796 (01)2 4026704 41748 7(17)280426(11)230426(10)23D0900 (01)2 4026704 41748 7(17)280530(11)230530(10)23E1180 (01)2 4026704 41748 7(17)280809(11)230809(10)23H1834 (01)2 4026704 41748 7(17)290319(11)240319(10)24C0647 (01)2 4026704 41748 7(17)290522(11)240522(10)24E1133 (01)2 4026704 41748 7(17)290729(11)240729(10)24G1865 (01)2 4026704 41748 7(17)290731(11)240731(10)24G1864 (01)2 4026704 41748 7(17)291112(11)241112(10)24K2820 Lot/Batch Numbers: 21E1485 21H2304 21H2594 21H2595 21K3161 21L3593 22A0175 22C0661 22E1386 22J2777 22K3102 22K3269 22K3270 23A0102 23D0796 23D0900 23E1180 23H1834 24C0647 24E1133 24G1865 24G1864 24K2820 Pilling¿ Wecksorb Neurosponges (Cotton), 1" x 1" X-Ray Detectable Catalog Number: 200101 UDI codes: (01)2 4026704 41749 4(17)260520(11)210520(10)21E1503 (01)2 4026704 41749 4(17)260531(11)210531(10)21E1546 (01)2 4026704 41749 4(17)260907(11)210907(10)21H2596 (01)2 4026704 41749 4(17)261019(11)211019(10)21K3162 (01)2 4026704 41749 4(17)261130(11)211130(10)21L3594 (01)2 4026704 41749 4(17)270304(11)220304(10)22B0456 (01)2 4026704 41749 4(17)270317(11)220317(10)22C0677 (01)2 4026704 41749 4(17)270506(11)220506(10)22D1299 (01)2 4026704 41749 4(17)271031(11)221031(10)22K3271 (01)2 4026704 41749 4(17)280201(11)230201(10)23A0103 (01)2 4026704 41749 4(17)280602(11)230602(10)23E1235 (01)2 4026704 41749 4(17)280810(11)230810(10)23H1835 (01)2 4026704 41749 4(17)290730(11)240730(10)24G1863 (01)2 4026704 41749 4(17)290821(11)240821(10)24H2070 (01)2 4026704 41749 4(17)291114(11)241114(10)24K2821 Lot/Batch Numbers: 21E1503 21E1546 21H2596 21K3162 21L3594 22B0456 22C0677 22D1299 22K3271 23A0103 23E1235 23H1835 24G1863 24H2070 24K2821 Pilling¿ Wecksorb Neurosponges (Cotton), 1" x 3" X-Ray Detectable Catalog Number: 200102 UDI codes: (01)2 4026704 41750 0(17)260513(11)210513(10)21E1397 (01)2 4026704 41750 0(17)260529(11)210529(10)21E1547 (01)2 4026704 41750 0(17)260907(11)210907(10)21H2597 (01)2 4026704 41750 0(17)261213(11)211213(10)21M3732 (01)2 4026704 41750 0(17)270321(11)220321(10)22C0720 (01)2 4026704 41750 0(17)270509(11)220509(10)22D1297 (01)2 4026704 41750 0(17)270914(11)220914(10)22J2778 (01)2 4026704 41750 0(17)271101(11)221101(10)22K3272 (01)2 4026704 41750 0(17)271103(11)221103(10)22K3273 (01)2 4026704 41750 0(17)280201(11)230201(10)23A0104 (01)2 4026704 41750 0(17)280602(11)230602(10)23E1236 (01)2 4026704 41750 0(17)280913(11)230913(10)23J2156 (01)2 4026704 41750 0(17)290501(11)240501(10)24D0986 (01)2 4026704 41750 0(17)290801(11)240801(10)24G1867 (01)2 4026704 41750 0(17)291031(11)241031(10)24K2761 (01)2 4026704 41750 0(17)291118(11)241118(10)24K2822 Lot/Batch Numbers: 21E1397 21E1547 21H2597 21M3732 22C0720 22D1297 22J2778 22K3272 22K3273 23A0104 23E1236 23J2156 24D0986 24G1867 24K2761 24K2822 Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 1 1/2" X-Ray Detectable Catalog Number: 200103 UDI codes: (01)2 4026704 41751 7(17)260514(11)210514(10)21E1398 (01)2 4026704 41751 7(17)260520(11)210520(10)21E1504 (01)2 4026704 41751 7(17)260812(11)210812(10)21H2305 (01)2 4026704 41751 7(17)260909(11)210909(10)21H2599 (01)2 4026704 41751 7(17)261001(11)211001(10)21H2598 (01)2 4026704 41751 7(17)261019(11)211019(10)21K3163 (01)2 4026704 41751 7(17)261213(11)211213(10)21M3733 (01)2 4026704 41751 7(17)270304(11)220304(10)22B0457 (01)2 4026704 41751 7(17)270420(11)220420(10)22D1035 (01)2 4026704 41751 7(17)270608(11)220608(10)22D1298 (01)2 4026704 41751 7(17)271107(11)221107(10)22K3274 (01)2 4026704 41751 7(17)280202(11)230202(10)23A0105 (01)2 4026704 41751 7(17)280425(11)230425(10)23D0901 (01)2 4026704 41751 7(17)280605(11)230605(10)23E1237 (01)2 4026704 41751 7(17)280807(11)230807(10)23H1836 (01)2 4026704 41751 7(17)290502(11)240502(10)24D0987 (01)2 4026704 41751 7(17)290726(11)240726(10)24G1868 (01)2 4026704 41751 7(17)290822(11)240822(10)24H2072 (01)2 4026704 41751 7(17)290822(11)240822(10)24H2073 (01)2 4026704 41751 7(17)291116(11)241116(10)24K2823 Lot/Batch Numbers: 21E1398 21E1504 21H2305 21H2599 21H2598 21K3163 21M3733 22B0457 22D1035 22D1298 22K3274 23A0105 23D0901 23E1237 23H1836 24D0987 24G1868 24H2072 24H2073 24K2… (truncated, 12115 characters total — see the official FDA record for the full value)
Recalling firm:
TELEFLEX LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

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

Recall #:
99043
Lot/product code:
1) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25BDA811; 2) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDB415; 3) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDC095; 4) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25ADB324; 5) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25FDB473; 6) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25GDA336; 7) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 24FDB427; 8) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25ABH622; 9) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBA788; 10) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBF665; 11) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25DBR616; 12) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25FBA415; 13) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25HBT666; 14) DYNJ9855016X, UDI-DI: 10198459571374(each), 40198459571375(case), Lot Number: 25KBO109
Recalling firm:
Medline Industries, LP
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UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL AND ARTERIAL LINE TOTE, Model Number: DYNJ8407

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

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

Recall #:
99043
Lot/product code:
1) ACC011142, UDI-DI: 10198459721342(each), 40198459721343(case), Lot Number: 26DDA462; 2) ACC011142, UDI-DI: 10198459721342(each), 40198459721343(case), Lot Number: 26DDA547; 3) DYNJ8407, UDI-DI: 10198459704543(each), 40198459704544(case), Lot Number: 26DBB599
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

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

Recall #:
99043
Lot/product code:
1) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25BDA811; 2) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDB415; 3) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDC095; 4) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25ADB324; 5) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25FDB473; 6) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25GDA336; 7) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 24FDB427; 8) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25ABH622; 9) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBA788; 10) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBF665; 11) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25DBR616; 12) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25FBA415; 13) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25HBT666; 14) DYNJ9855016X, UDI-DI: 10198459571374(each), 40198459571375(case), Lot Number: 25KBO109
Recalling firm:
Medline Industries, LP
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UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System

It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.

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

Recall #:
98894
Lot/product code:
GTIN 07613327634914, Serial Number 2521008873
Recalling firm:
Stryker Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851)

These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

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

Recall #:
98838
Lot/product code:
1. Material: 333867; UDI-DI Primary/Unit of Use: 4046964180842/4046964180835; Batch Numbers: 0061965993, 0061968406, 0061971306, 0061971487, 0061978629, 0061978630; 2. Material: 333862; UDI-DI Primary/Unit of Use: 4046964180743/4046964180736; Batch Numbers: 0061947858, 0061954126, 0061970779, 0061970781, 0061970783; 3. Material: 332607; UDI-DI Primary/Unit of Use: 4046964558757/4046964558740; Batch Number: 0061976109; 4. Material: 333868; UDI-DI Primary/Unit of Use: 4046964180866/4046964180859; Batch Numbers: 0061958120, 0061958276, 0061960474, 0061960475, 0061960476, 0061960477, 0061960478, 0061965732, 0061965733, 0061965734, 0061965735, 0061965736, 0061965737, 0061965738, 0061965739, 0061965740, 0061965741, 0061965743, 0061969393, 0061969394, 0061969395, 0061969397, 0061969438, 0061969439, 0061969440, 0061969441, 0061970674, 0061970675, 0061970726, 0061970727, 0061970729, 0061970730, 0061971108, 0061975011, 0061975012, 0061975013, 0061975014, 0061975015, 0061975016, 0061975017, 0061975018, 0061976996, 0061976997, 0061976998, 0061976999, 0061979852; 5. Material: 333865; UDI-DI Primary/Unit of Use: 4046964180804/4046964180798; Batch Numbers: 0061952152, 0061964964, 0061968295; 6. Material: 333871; UDI-DI Primary/Unit of Use: 4046964180903/4046964180897; Batch Number: 0061954099; 7. Material: 333851; UDI-DI Primary/Unit of Use: 4046964180606/4046964180590; Batch Numbers: 0061954106, 0061954107, 0061954108, 0061954123, 0061954124, 0061954125, 0061954130, 0061954131, 0061954132, 0061954134, 0061954135, 0061960457, 0061960458, 0061960459, 0061960460, 0061960461, 0061965687, 0061965688, 0061965689, 0061967621, 0061967623, 0061967624, 0061967626, 0061969508, 0061969986, 0061970102, 0061970104, 0061970105, 0061970106, 0061970107, 0061970109, 0061970110, 0061970860, 0061970861, 0061970863, 0061970864, 0061970866, 0061970867, 0061971261, 0061971262, 0061971263, 0061971264, 0061971265, 0061971266, 0061971268, 0061971269, 0061972812, 0061972813, 0061974198, 0061974199, 0061974200, 0061974201, 0061974247, 0061974248, 0061974249, 0061974250, 0061974251, 0061974253, 0061974559, 0061974562, 0061974563, 0061974564, 0061974569, 0061975004, 0061975005, 0061975006, 0061975007, 0061975008, 0061975009, 0061975810, 0061976903, 0061976904, 0061976905, 0061976906, 0061976908, 0061976909, 0061976910, 0061976911, 0061976912, 0061976913, 0061976914, 0061976915, 0061979785, 0061979786, 0061979787, 0061979788, 0061979790, 0061979791, 0062019490;
Recalling firm:
B Braun Medical Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (560428), SSK L G H (ORIGINAL CUST) (560462), SSK H M H (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK K F H (560497), SSK T J U H (560513), SSK O M C (560521), SSK CUSTOM SPINAL TRAY (560523), SSK O R M C (560533), SSK B S H S 20115122 (560538), SSK M M (560572), SSK M S 27GA PENCAN SPINAL TRAY (560580), SSK S T H & C (560584), SSK U C (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK M C - BUPIVACAINE TRAY (560609), SSK T M C (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK E O & S H-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK M C OB DEPT - SPINAL (560645), SSK B H M (560646), SSK M G M C (560647), SSK S M H (560648), SSK H H S (560660), O S U M C SPINAL TRAY SSK (560667), A M C, SSK (560670), S B H - SPINAL TRAY SSK (560672);

These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

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

Recall #:
98838
Lot/product code:
1. Material: 560074; UDI-DI Primary/Individual Unit of Use: 04046964317873/04046964317859; Batch Numbers: 0061960383, 0061972565; 2. Material: 560214; UDI-DI Primary/Individual Unit of Use: 04046964318061/04046964318054; Batch Numbers: 0061971346, 0061977782; 3. Material: 560272; UDI-DI Primary/Individual Unit of Use: 04046964318108/04046964318085; Batch Numbers: 0061960367, 0061971330; 4. Material: 560327; UDI-DI Primary/Individual Unit of Use: 04046964318221/04046964318207; Batch Numbers: 0061960420, 0061977751; 5. Material: 560394; UDI-DI Primary/Individual Unit of Use: 04046964318429/04046964318405; Batch Numbers: 0061964747, 0061976985, 0061983313; 6. Material: 560428; UDI-DI Primary/Individual Unit of Use: 04046964318610/04046964318597; Batch Numbers: 0061976150, 0061979927; 7. Material: 560462; UDI-DI Primary/Individual Unit of Use: 04046964318764/04046964318740; Batch Number: 0061977772; 8. Material: 560465; UDI-DI Primary/Individual Unit of Use: 04046964318801/04046964318788; Batch Numbers: 0061976120, 0061976122, 0062024615; 9. Material: 560476; UDI-DI Primary/Individual Unit of Use: 04046964318948/04046964318931; Batch Numbers: 0061964879, 0061977776, 0061985361; 10. Material: 560497; UDI-DI Primary/Individual Unit of Use: 04046964319136/04046964319112; Batch Numbers: 0061967077, 0061985362; 11. Material: 560513; UDI-DI Primary/Individual Unit of Use: 04046964319273/04046964319259; Batch Numbers: 0061961836, 0061977766; 12. Material: 560521; UDI-DI Primary/Individual Unit of Use: 04046964319440/04046964319426; Batch Numbers: 0061967083, 0061977226; 13. Material: 560523; UDI-DI Primary/Individual Unit of Use: 04046964319471/04046964319457; Batch Numbers: 0061952176, 0061971321; 14. Material: 560533; UDI-DI Primary/Individual Unit of Use: 04046964319518/04046964319495; Batch Numbers: 0061954120, 0061971287, 0061971288; 15. Material: 560538; UDI-DI Primary/Individual Unit of Use: 04046964319587/04046964319563; Batch Numbers: 0061971325, 0061973771; 16. Material: 560572; UDI-DI Primary/Individual Unit of Use: 04046964319990/04046964319976; Batch Number: 0061961001; 17. Material: 560580; UDI-DI Primary/Individual Unit of Use: 04046964320194/04046964320170; Batch Number: 0061967090; 18. Material: 560584; UDI-DI Primary/Individual Unit of Use: 04046964320293/04046964320286; Batch Number: 0061961847; 19. Material: 560587; UDI-DI Primary/Individual Unit of Use: 04046964320408/04046964320378; Batch Number: 0061972579; 20. Material: 560603; UDI-DI Primary/Individual Unit of Use: 04046964320842/04046964320828; Batch Numbers: 0061951279, 0061954147, 0061958274, 0061969404, 0061969405, 0061970744, 0061974805; 21. Material: 560606; UDI-DI Primary/Individual Unit of Use: 04046964320958/04046964320927; Batch Numbers: 0061965746, 0061965762, 0061971283, 0061971284, 0061971285; 22. Material: 560607; UDI-DI Primary/Individual Unit of Use: 04046964320989/04046964320965; Batch Numbers: 0061958137, 0061972577, 0061985364; 23. Material: 560609; UDI-DI Primary/Individual Unit of Use: 04046964321047/04046964321030; Batch Numbers: 0061958142, 0061975207, 0061985374; 24. Material: 560613; UDI-DI Primary/Individual Unit of Use: 04046964321153/04046964321146; Batch Number: 0061972578; 25. Material: 560619; UDI-DI Primary/Individual Unit of Use: 04046964321306/04046964321290; Batch Numbers: 0061954114, 0061971313; 26. Material: 560621; UDI-DI Primary/Individual Unit of Use: 04046964321375/04046964321368; Batch Numbers: 0061961853, 0061976112, 0061977798; 27. Material: 560628; UDI-DI Primary/Individual Unit of Use: 04046964526749/04046964526732; Batch Numbers: 0061954111, 0061959460; 28. Material: 560645; UDI-DI Primary/Individual Unit of Use: 04046964809088/04046964809071; Batch Numbers: 0061967991, 0061977778; 29. Material: 560646; UDI-DI Primary/Individual Unit of Use: 04046964809101/04046964809095; Batch Number: 0061957394; 30. Material: 560647; UDI-DI Primary/Individual Unit of Use: 04046964809125/04046964809118; Batch Numbers: 0061971336, 0061977571, 0061985370; 31. Material: 560648; UDI-DI Primary/Individual Unit of Use: 04046964809149/04046964809132; Batch Numbers: 0061961002, 0061977800, 0061977801; 32. Material: 560660; UDI-DI Primary/Individual Unit of Use: 04046955331864/04046955331857; Batch Number: 0061958133; 33. Material: 560667; UDI-DI Primary/Individual Unit of Use: 04046955595891/04046955595884; Batch Numbers: 0061966001, 0061976124, 0061977803; 34. Material: 560670; UDI-DI Primary/Individual Unit of Use: 04046955595945/04046955595938; Batch Number: 0061972569; 35. Material: 560672; UDI-DI Primary/Individual Unit of Use: 04046955595983/04046955595976; Batch Numbers: 0061967078, 0061977783;
Recalling firm:
B Braun Medical Inc
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