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Recalls affecting Mississippi

Data last updated: September 11, 2026 at 1:08 PM UTC

16,761 recalls found
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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

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UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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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.

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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/virusE. coliAnnounced 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

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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.

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UnclassifiedAllergenMilkUndeclaredAnnounced 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.

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UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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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.

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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.

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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UnclassifiedBacteria/virusSalmonellaAnnounced 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)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2021

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

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

Recall #:
89376
Lot/product code:
All systems.
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2021

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

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▸Full report

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

Recall #:
89376
Lot/product code:
All systems.
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2021

Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00

Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)

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

Recall #:
89333
Lot/product code:
Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 28, 2021

Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.

The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.

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

Recall #:
89488
Lot/product code:
Affected lots were distributed in the United States from 1/18/2017 to 8/26/2021. These lots have expiration dates of 1/01/2022 through 12/01/2026. Catalog Number 4310, Package DI M84943100, Package DI Number M84943101; Catalog Number 4320, Package DI M84943200, Package DI Number M84943201; Lot Numbers: H12-16-112 H12-16-113 H12-16-114 H01-17-002 H01-17-003 H01-17-004 H01-17-005 H01-17-101 H01-17-134 H01-17-135 H01-17-136 H02-17-044 H02-17-045 H02-17-046 H02-17-047 H02-17-048 H03-17-113 H03-17-114 H03-17-115 H03-17-116 H03-17-117 H03-17-233 H03-17-234 H03-17-235 H03-17-236 H03-17-237 H03-17-238 H05-17-119 H05-17-120 H05-17-121 H05-17-122 H05-17-123 H05-17-124 H06-17-142 H06-17-143 H06-17-144 H06-17-145 H07-17-112 H07-17-113 H07-17-114 H07-17-115 H08-17-127 H08-17-128 H08-17-129 H08-17-130 H08-17-131 H08-17-269 H08-17-270 H08-17-271 H08-17-272 H08-17-273 H09-17-102 H09-17-103 H09-17-104 H10-17-053 H10-17-056 H10-17-057 H10-17-058 H10-17-059 H10-17-060 H10-17-061 H11-17-146 H11-17-147 H11-17-148 H11-17-149 H11-17-150 H11-17-151 H12-17-120 H12-17-121 H12-17-122 H12-17-123 H12-17-124 H02-18-001 H02-18-002 H02-18-003 H02-18-004 H02-18-005 H02-18-209 H02-18-210 H02-18-211 H02-18-212 H02-18-219 H02-18-220 H02-18-221 H03-18-176 H03-18-177 H03-18-178 H03-18-179 H03-18-180 H04-18-038 H04-18-039 H04-18-040 H04-18-151 H04-18-152 H04-18-153 H04-18-154 H04-18-155 H04-18-156 H04-18-157 H05-18-177 H05-18-178 H05-18-179 H05-18-180 H06-18-111 H06-18-112 H06-18-113 H06-18-114 H07-18-017 H07-18-018 H07-18-019 H07-18-021 H07-18-020 H08-18-070 H08-18-071 H08-18-073 H08-18-072 H08-18-206 H08-18-207 H08-18-208 H10-18-117 H10-18-118 H10-18-120 H10-18-121 H10-18-119 H11-18-133 H11-18-134 H11-18-135 H11-18-136 H11-18-137 H01-19-023 H01-19-024 H01-19-025 H01-19-026 H01-19-027 H12-18-086 H12-18-087 H12-18-088 H12-18-089 H12-18-090 H01-19-178 H01-19-179 H01-19-180 H01-19-181 H01-19-182 H01-19-183 H02-19-184 H02-19-185 H02-19-186 H02-19-187 H02-19-188 H02-19-189 H02-19-190 H04-19-067 H04-19-068 H04-19-069 H04-19-070 H04-19-071 H04-19-072 H04-19-073 H05-19-102 H05-19-103 H05-19-104 H05-19-160 H05-19-161 H05-19-162 H05-19-163 H05-19-164 H06-19-001 H06-19-003 H06-19-004 H06-19-002 H06-19-310 H06-19-311 H06-19-312 H06-19-313 H06-19-314 H06-19-315 H06-19-316 H06-19-317 H07-19-129 H07-19-130 H07-19-131 H07-19-132 H07-19-133 H07-19-134 H08-19-176 H08-19-177 H08-19-178 H08-19-179 H08-19-180 H09-19-113 H09-19-114 H09-19-115 H09-19-116 H10-19-104 H10-19-105 H10-19-107 H10-19-106 H10-19-108 H11-19-120 H11-19-121 H11-19-122 H01-20-008 H01-20-009 H01-20-010 H01-20-011 H01-20-012 H01-20-013 H01-20-207 H01-20-208 H01-20-209 H01-20-210 H01-20-211 H01-20-212 H01-20-213 H02-20-125 H02-20-126 H02-20-127 H02-20-128 H02-20-129 H03-20-169 H03-20-170 H03-20-171 H03-20-173 H03-20-172 H04-20-097 H04-20-098 H04-20-099 H04-20-100 H04-20-101 H04-20-120 H04-20-121 H04-20-122 H04-20-123 H04-20-124 H05-20-109 H05-20-110 H05-20-111 H05-20-112 H05-20-113 H05-20-114 H05-20-115 H05-20-116 H05-20-117 H05-20-118 H06-20-033 H06-20-034 H06-20-035 H06-20-036 H06-20-037 H07-20-060 H07-20-061 H07-20-062 H07-20-063 H08-20-102 H08-20-103 H08-20-104 H08-20-105 H08-20-106 H08-20-107 H09-20-040 H09-20-041 H09-20-042 H09-20-043 H10-20-074 H10-20-075 H10-20-076 H10-20-077 H10-20-078 H11-20-096 H11-20-097 H11-20-098 H11-20-099 H11-20-100 H12-20-160 H12-20-161 H12-20-162 H12-20-163 H12-20-164 H01-21-105 H01-21-106 H01-21-107 H01-21-108 H01-21-110 H01-21-109 H02-21-047 H02-21-048 H02-21-049 H02-21-050 H02-21-051 H03-21-158 H03-21-159 H03-21-160 H03-21-161 H03-21-162 H05-21-137 H05-21-138 H05-21-139 H05-21-140 H06-21-148 H06-21-149 H06-21-150 H06-21-151 H06-21-152 H07-21-005 H07-21-006 H07-21-007 H07-21-008 H07-21-009 H07-21-133 H07-21-134 H07-21-135 H07-21-136 H07-21-137 H07-21-138 H12-16-115 H12-16-116 H02-17-131 H02-17-132 H02-17-133 H02-17-134 H02-17-135 H02-17-136 H03-17-118 H03-17-119 H03-17-120 H04-17-030 H04-17-031 H04-17-032 H04-17-033 H05-17-098 H05-17-099 H05-17-100 H05-17-101 H06-17-146 H06-17-147 H06-17-148 H06-17-149 H07-17-116 H07-17-117 H07-17-118 H07-17-119 H08-17-132 H08-17-133 H08-17-134 H08-17-135 H08-17-274 H08-17-275 H08-17-276 H08-17-277 H10-17-062 H11-17-109 H11-17-110 H11-17-111 H11-17-112 H12-17-125 H12-17-126 H12-17-127 H12-17-128 H12-17-129 H02-18-006 H02-18-007 H02-18-008 H02-18-009 H02-18-010 H02-18-213 H02-18-214 H02-18-215 H03-18-181 H03-18-182 H03-18-183 H04-18-158 H04-18-159 H05-18-181 H05-18-182 H05-18-183 H07-18-022 H07-18-023 H08-18-082 H08-18-083 H08-18-084 H08-18-204 H08-18-205 H10-18-114 H10-18-115 H10-18-116 H11-18-138 H11-18-139 H11-18-140 H01-19-184 H01-19-185 H01-19-186 H01-19-187 H01-19-188 H01-19-189 H01-19-190 H01-19-191 H01-19-192 H01-19-193 H01-19-194 H01-19-195 H01-19-196 H01-19-197 H01-19-198 H03-19-087 H03-19-088 H03-19-089 H04-19-124 H04-19-125 H04-19-126 H04-19-127 H06-19-318 H06-19-319 H06-19-320 H07-19-135 H07-19-136 H07-19-137 H08-19-173 H08-19-174 H08-19-175 H09-19-117 H09-19-118 H09-19-119 H10-19-109 H10-19-111 H01-20-014 H01-20-0… (truncated, 5321 characters total — see the official FDA record for the full value)
Recalling firm:
Hobbs Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 29, 2021

MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes

Micro-Kill Bleach Wipes contain not meeting quality requirements (low) levels of Sodium Hypochlorite.

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

Recall #:
89440
Lot/product code:
a. Model No.: MSC351400AN; UDI: 10888277652514; Lot No.: 209 and Batch ID: 20083 Lot No.: 210 and Batch ID: 20085 Lot No.: 211 and Batch ID: 20083 and 20084 Lot No.: 212 and Batch ID: 20084 and 20085 Lot No.: 213 and Batch ID: 20085 and 20086 Lot No.: 214 and Batch ID: 20086 and 20087 Lot No.: 215 and Batch ID: 20087 Lot No.: 216 and Batch ID: 20087 and 20090 Lot No.: 217 and Batch ID: 20090 Lot No.: 218 and Batch ID: 20090 and 20091 Lot No.: 231 and Batch ID: 20104 and 20105 Lot No.: 233 and Batch ID: 20105, 20106, and 20107 Lot No.: 235 and Batch ID: 20107 and 20108 Lot No.: 236 and Batch ID: 20108, 20109, and 20111 Lot No.: 238 and Batch ID: 20111 and 20112 Lot No.: 240 and Batch ID: 20112 and 20113 Lot No.: 241 and Batch ID: 20113 and 20114 Lot No.: 243 and Batch ID: 20114 and 20115 Lot No.: 244 and Batch ID: 20115 Lot No.: 245 and Batch ID: 20115 and 20118 Lot No.: 246 and Batch ID: 20118 Lot No.: 247 and Batch ID: 20118 and 20119 Lot No.: 248 and Batch ID: 20119 Lot No.: 249 and Batch ID: 20119 and 20120 Lot No.: 250 and Batch ID: 20120 Lot No.: 254 and Batch ID: 20132 Lot No.: 256 and Batch ID: 20132and 20133 Lot No.: 258 and Batch ID: 20136 and 20137 Lot No.: 260 and Batch ID: 20137 and 20139 Lot No.: 261 and Batch ID: 20139 and 20140 Lot No.: 263 and Batch ID: 20140 and 20141 Lot No.: 264 and Batch ID: 20141 and 20142 Lot No.: 288 and Batch ID: 20219 Lot No.: 289 and Batch ID: 20219 and 20220 Lot No.: 290 and Batch ID: 20220 and 20221 Lot No.: 291 and Batch ID: 20221 and 20223 Lot No.: 292 and Batch ID: 20223 and 20224 Lot No.: 293 and Batch ID: 20224, 20225, and 20232 Lot No.: 301 and Batch ID: 20293 and 20294 Lot No.: 302 and Batch ID: 20294 and 20295 Lot No.: 303 and Batch ID: 20295 and 20296 Lot No.: 304 and Batch ID: 20296 Lot No.: 305 and Batch ID: 20297, 20300, and 20301 Lot No.: 306 and Batch ID: 20300, 20301, and 20424 Lot No.: 307 and Batch ID: 20315 Lot No.: 308 and Batch ID: 20315 and 20316 Lot No.: 309 and Batch ID: 20316 and 20317 Lot No.: 310 and Batch ID: 20317 and 20318 Lot No.: 311 and Batch ID: 20318 Lot No.: 343 and Batch ID: 21047 and 21048 Lot No.: 344 and Batch ID: 21048 and 21049 Lot No.: 345 and Batch ID: 21049 and 21050 Lot No.: 346 and Batch ID: 21050 Lot No.: 347 and Batch ID: 21050 and 20153 Lot No.: 348 and Batch ID: 21053 and 21054 Lot No.: 352 and Batch ID: 21063 Lot No.: 353 and Batch ID: 21063 and 21064 Lot No.: 354 and Batch ID: 21064 Lot No.: 355 and Batch ID: 21064 and 21067 Lot No.: 356 and Batch ID: 21067 Lot No.: 360 and Batch ID: 21112 Lot No.: 361 and Batch ID: 21102 and 21103 Lot No.: 362 and Batch ID: 21103, 21105, 21109, and 21173 Lot No.: 363 and Batch ID: 21109 and 21110 Lot No.: 364 and Batch ID: 21110 and 21111 Lot No.: 365 and Batch ID: 21111 and 21112 Lot No.: 366 and Batch ID: 21112 Lot No.: 367 and Batch ID: 21116 and 21173 Lot No.: 368 and Batch ID: 21116 and 21117 Lot No.: 369 and Batch ID: 21117 Lot No.: 370 and Batch ID: 21117 and 21118 b. Model No.: MSC351410AN; UDI: 10888277652521; Lot No.: 208 and Batch ID: 20079 Lot No.: 209 and Batch ID: 20080, 20083, and 20303 Lot No.: 210 and Batch ID: 20083, 20084, 20085, and 20086 Lot No.: 213 and Batch ID: 20086 Lot No.: 214 and Batch ID: 20086 and 20087 Lot No.: 215 and Batch ID: 20087 Lot No.: 216 and Batch ID: 20087 and 20090 Lot No.: 217 and Batch ID: 20090 Lot No.: 218 and Batch ID: 20090 and 20091 Lot No.: 219 and Batch ID: 20091 and 20092 Lot No.: 220 and Batch ID: 20092, 20093, and 20094 Lot No.: 222 and Batch ID: 20094 and 20095 Lot No.: 224 and Batch ID: 20095, 20097, and 20098 Lot No.: 226 and Batch ID: 20098 and 20099 Lot No.: 228 and Batch ID: 20099, 20100, and 20101 Lot No.: 229 and Batch ID: 20104 Lot No.: 230 and Batch ID: 20101, 20104, and 20105 Lot No.: 232 and Batch ID: 20105 and 20106 Lot No.: 234 and Batch ID: 20106, 20107, and 20108 Lot No.: 237 and Batch ID: 20108 and 20109 Lot No.: 239 and Batch ID: 20113 Lot No.: 242 and Batch ID: 20113 and 20114 Lot No.: 252 and Batch ID: 20125 Lot No.: 253 and Batch ID: 20125 and 20126 Lot No.: 267 and Batch ID: 20153 Lot No.: 268 and Batch ID: 20153 and 20154 Lot No.: 269 and Batch ID: 20154 and 20155 Lot No.: 270 and Batch ID: 20155 and 20156 Lot No.: 271 and Batch ID: 20156 and 20157 Lot No.: 277 and Batch ID: 20167 and 20168 Lot No.: 279 and Batch ID: 20168 and 20169 Lot No.: 280 and Batch ID: 20169 and 20170 Lot No.: 282 and Batch ID: 20170 and 20171 Lot No.: 293 and Batch ID: 20232 Lot No.: 294 and Batch ID: 20232 and 20233 Lot No.: 295 and Batch ID: 20266 Lot No.: 296 and Batch ID: 20266, 20615, and 20616 Lot No.: 297 and Batch ID: 20266, 20267, and 20616 Lot No.: 298 and Batch ID: 20267 Lot No.: 299 and Batch ID: 20268, 20269, and 20620 Lot No.: 300 and Batch ID: 20290 and 20293 Lot No.: 307 and Batch ID: 20314 and 20315 Lot No.: 311 and Batch ID: 20322 Lot No.: 312 and Batch ID: 20322 and 20323 Lot No.: 321 and Batch ID: 20346 and 20347 Lot No.: 322 and Batch ID: 20347, 20348, and 20349 Lot No… (truncated, 5598 characters total — see the official FDA record for the full value)
Recalling firm:
MEDLINE INDUSTRIES, LP - Northfield
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 29, 2021

YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.

The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.

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

Recall #:
89330
Lot/product code:
Lot Number 165892 UDI (01)10302731163120(13)210712(10)165892
Recalling firm:
Young Dental Mfg Co I LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 29, 2021

Baxter Spectrum IQ Infusion Pumps, Product code 3570009.

There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.

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

Recall #:
89017
Lot/product code:
All serial numbers, GTIN 00085412610900.
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 29, 2021

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.

There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.

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▸Full report

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

Recall #:
89017
Lot/product code:
All serial numbers, GTIN 00085412498683.
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 30, 2021

RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Including Service Paks: Product name (build number) UDI-DI RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013 RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation/RayPlan 9A (9.0.0.113) 07350002010174 RayStation/RayPlan 9B (9.1.0.933) 07350002010266 RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297

If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running

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

Recall #:
89631
Lot/product code:
Software: 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483 UDI: 07350002010013 07350002010082 07350002010075 07350002010242 07350002010068 07350002010112 07350002010136 07350002010129 07350002010204 07350002010235 07350002010174 07350002010266 07350002010297 07350002010013 07350002010082 07350002010075 07350002010242 07350002010068
Recalling firm:
RAYSEARCH LABORATORIES AB
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UnclassifiedRisk not yet known
Medical deviceRecalled January 4, 2022

The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. it is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Optima Coil System and XCEL Detachment Controller(s) are sold separately. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller.

Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.

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

Recall #:
89338
Lot/product code:
Model/REF: OPTI0204CSF10 Lot Number: F210500134 UDI Code: 00818053026010 Model/REF: OPTI0407CSF10 Lot Number: F210500135 UDI Code: 00818053026096
Recalling firm:
BALT USA, LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled January 4, 2022

INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

The affected screwdrivers are not meeting quality requirements and may not mate with the Surfix Alpha Lock screw

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

Recall #:
89382
Lot/product code:
UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG
Recalling firm:
Smith & Nephew, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled January 5, 2022

BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066

May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument.

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

Recall #:
89358
Lot/product code:
All unexpired analyzers (Exp. Date 12/2021 - 8/2024) UDI: 00382902560661
Recalling firm:
Becton Dickinson & Co.
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UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2022

FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth

Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin

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

Recall #:
89449
Lot/product code:
Manufactured from April 1, 2021 to September 15, 2021. Lot Numbers: 120421-a 70921 30521 180621d 010421 140621a 060721a 120421-b 270521 130521a 090721a 060421-a 140621b 060721b 120421-c 030621 130521b 090721b 060421-b 140621c 060721c 220421-a 160721a 130521c 130721a 060421-c 150621a 060721d 220421-b 160721b 200521a 130721b 080421-a 150621b 070721a 220421-c 180721 200521b 130721c 080421-b 150621c 070721b 230621a 280721 200521c 130721d 080421-c 210621a 070721c 230621b 290721 250521a 300821a 130421-a 210621b 070721d 230621c 100821 250521b 300821b 130421-b 210621c 080721a 230621d 100821 250521c 310821a 130421-c 210621d 080721b 170721a 090621c 310521a 210721a 200421-a 220621a 080721c 170721b 180721a 310521b 210721b 200421-b 220621b 080721d 190721 180721b 310521c 210721c 200421-c 220621c 120721a 290721a 180721c 070621a 40821 260421-a 220621d 120721b 290721b 180721d 070621b 60821 260421-b 300621a 120721c 290721c 190721a 070621c 130821 260421-c 300621b 120721d 90821 190721b 110621a 090921-2 270421-a 300621c 140721a 110821 160821 110621b 100921 270421-b 300621d 140721b 120821 270821 110621c 140921-1 270421-c 050721a 140721c 190821 190421a 180621a 140921-2 030521 050721b 140721d 230821 190421b 190621b 140921-3 040521a 050721c 150721a 240821 190421c 180621c 140921-4 040521b 050721d 200721a 070421-a 210421-a 260521a 290621a 040521c 310821b 200721b 070421-b 210421-b 260521b 290621b 170521a 010921a 200721c 070421-c 210421-c 160621a 290621c 170521b 010921b 200721d 170821 280721a 160621b 290621d 170521c 020921a 300721a 180821 280721b 160621c 280621a 180521a 020921b 300721b 110521 280721c 160621d 280621b 180521b 030921a 300721c 200821 030821a 170721 280621c 180521c 030921b 50821 020621 030821b 140421-b 280621d 190521a 070921 200421 030821c 140421-a 020821a 090621a 080921 250821 130921-1 180821b 020821b 090621b 080921-2 260821 130921-2 100921-2 020821c 090921 140421-c
Recalling firm:
Envisiontec US Llc
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UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2022

Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.

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

Recall #:
93737
Lot/product code:
UDI-DI 00884838088115 Ingenia Serial number / Accessory Serial Number 45294 100029 45294 100030
Recalling firm:
Philips North America
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UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2022

Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.

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

Recall #:
93737
Lot/product code:
UDI-DI 00884838090040 Ingenia Serial number / Accessory Serial Number 47004 100020 47019 100024 47190 100022 47200 100025 47210 100019 47227 100063 47231 100056 47271 100032 47281 100028 47281 100031
Recalling firm:
Philips North America
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UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2022

FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin

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

Recall #:
89449
Lot/product code:
Manufactured from April 1, 2021 to September 15, 2021. 120421-a 70921 30521 180621d 010421 140621a 060721a 120421-b 270521 130521a 090721a 060421-a 140621b 060721b 120421-c 030621 130521b 090721b 060421-b 140621c 060721c 220421-a 160721a 130521c 130721a 060421-c 150621a 060721d 220421-b 160721b 200521a 130721b 080421-a 150621b 070721a 220421-c 180721 200521b 130721c 080421-b 150621c 070721b 230621a 280721 200521c 130721d 080421-c 210621a 070721c 230621b 290721 250521a 300821a 130421-a 210621b 070721d 230621c 100821 250521b 300821b 130421-b 210621c 080721a 230621d 100821 250521c 310821a 130421-c 210621d 080721b 170721a 090621c 310521a 210721a 200421-a 220621a 080721c 170721b 180721a 310521b 210721b 200421-b 220621b 080721d 190721 180721b 310521c 210721c 200421-c 220621c 120721a 290721a 180721c 070621a 40821 260421-a 220621d 120721b 290721b 180721d 070621b 60821 260421-b 300621a 120721c 290721c 190721a 070621c 130821 260421-c 300621b 120721d 90821 190721b 110621a 090921-2 270421-a 300621c 140721a 110821 160821 110621b 100921 270421-b 300621d 140721b 120821 270821 110621c 140921-1 270421-c 050721a 140721c 190821 190421a 180621a 140921-2 030521 050721b 140721d 230821 190421b 190621b 140921-3 040521a 050721c 150721a 240821 190421c 180621c 140921-4 040521b 050721d 200721a 070421-a 210421-a 260521a 290621a 040521c 310821b 200721b 070421-b 210421-b 260521b 290621b 170521a 010921a 200721c 070421-c 210421-c 160621a 290621c 170521b 010921b 200721d 170821 280721a 160621b 290621d 170521c 020921a 300721a 180821 280721b 160621c 280621a 180521a 020921b 300721b 110521 280721c 160621d 280621b 180521b 030921a 300721c 200821 030821a 170721 280621c 180521c 030921b 50821 020621 030821b 140421-b 280621d 190521a 070921 200421 030821c 140421-a 020821a 090621a 080921 250821 130921-1 180821b 020821b 090621b 080921-2 260821 130921-2 100921-2 020821c 090921 140421-c
Recalling firm:
Envisiontec US Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2022

Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.

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

Recall #:
93737
Lot/product code:
UDI-DI 00884838009820 Ingenia Serial number 41045 Accessory Serial Number 100018
Recalling firm:
Philips North America
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UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2022

BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200

May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts

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

Recall #:
89486
Lot/product code:
All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022
Recalling firm:
Becton Dickinson & Company
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UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.

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

Recall #:
89619
Lot/product code:
Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
Recalling firm:
Orthosoft, Inc. dba Zimmer CAS
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UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

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▸Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
▸Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
▸Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
▸Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
▸Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
▸Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)