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Recalls affecting Alabama

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

16,873 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 Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

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

Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

ALL 50 STATES
Full report

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

Recall #:
99301
Lot/product code:
DYKMBNDL116G UDI-DI 10198459156991 Lots 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 8, 2026

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

Weaker than it should be Drug

ALL 50 STATES
Full report

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

Recall #:
D-0656-2026
Lot/product code:
Lot # D2401522, Exp Date: 06/2026.
Recalling firm:
ACCORD HEALTHCARE, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

ALL 50 STATES
Full report

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

Recall #:
99301
Lot/product code:
DYNJT6105 UDI-DI 10198459539381 Lots 25JBM474 25LBS203
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

ALL 50 STATES
Full report

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

Recall #:
99301
Lot/product code:
DYNJ901822B UDI-DI 10195327319182 Lots 25KBA955 26CBL889
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

ALL 50 STATES
Full report

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

Recall #:
99301
Lot/product code:
CDS980523M UDI-DI 10195327508913 Lots 25KBJ177 25LBO527 26ABT761
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to Cefiderocol,

Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.

ALL 50 STATES
Full report

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

Recall #:
99226
Lot/product code:
Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461
Recalling firm:
Hardy Diagnostics
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

ALL 50 STATES
Full report

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

Recall #:
99301
Lot/product code:
DYNJ61206J UDI-DI 10198459488597 Lots 25IMF461 25LMG907
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

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

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

ALL 50 STATES
Full report

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

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

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

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

ALL 50 STATES
Full report

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

Recall #:
99326
Lot/product code:
UDI: 00763000448844/ Lot: D062531
Recalling firm:
Micro Therapeutics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

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

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

ALL 50 STATES
Full report

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

Recall #:
99326
Lot/product code:
UDI: 00763000448806/ Lot: D062612, D112860
Recalling firm:
Micro Therapeutics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

ALL 50 STATES
Full report

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

Recall #:
99301
Lot/product code:
DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

ARTIS icono ceiling. Model Number: 11328100.

Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

ALL 50 STATES
Full report

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

Recall #:
99224
Lot/product code:
Model Number: 11328100. UDI-DI: 4056869295923.
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro Spine Pack, Pack Number AMS16313; 5) Lami Kukkar Pack, Pack Number AMS17958; 6) Neuro Pack, Pack Number AMS6452B; 7) Neuro Lami Pack, Pack Number AMS9427C.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99323
Lot/product code:
1) Pack Number AMS12195C, UDI B098AMS12195C0, Lot Numbers: 217757, 222686, 224418, 225587, 227439, 228598, 230569, 234138, 235331, 236869, 238356. 2) Pack Number AMS12195D, UDI B098AMS12195D0, Lot Numbers: 240974. 3) Pack Number AMS12307, UDI B098AMS12307, Lot Numbers: 220948, 234027, 234756, 235909, 238000, 239036, 241680. 4) Pack Number AMS16313, UDI B098AMS163130, Lot Numbers: 241787. 5) Pack Number AMS17958, UDI B098AMS179580, Lot Numbers: 235956, 237474. 6) Pack Number AMS6452B, UDI B098AMS6452B0, Lot Numbers: 212195, 217806, 220779, 222520, 223506, 224581, 225839, 226652, 227717, 233855, 234503, 236416, 240751. 7) Pack Number AMS9427C, UDI B098AMS9427C0, Lot Numbers: 216097, 216766, 217573, 219221, 222013, 222070, 223714, 225092, 226568, 227813, 230393, 231091, 233313, 236502, 238280, 242405.
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4) Spine Pack, Pack Number AMS14991B; 5) Spinal Pack, Pack Number AMS16278; 6) Spine Pack, Pack Number AMS16499; 7) Spine Pack, Pack Number AMS16709; 8) Lumbar Spine Pack, Pack Number AMS17336; 9) Laminectomy Pack, Pack Number AMS17945; 10) Anterior Cervical Pack, Pack Number AMS17946; 11) Spine Pack, Pack Number AMS3150F; 12) Spine Pack, Pack Number AMS3150G; 13) Spine Pack, Pack Number AMS5451D; 14) ENT Pack, Pack Number AMS9771.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99323
Lot/product code:
1) Pack Number AMS13574A, UDI B098AMS13574A0, Lot Numbers: 235911, 236897. 2) Pack Number AMS14710B, UDI B098AMS14710B0, Lot Numbers: 224717, 230666, 213914, 236351. 3) Pack Number AMS14991A, UDI B098AMS14991A0, Lot Numbers: 215450, 230108. 4) Pack Number AMS14991B, UDI B098AMS14991B0, Lot Numbers: 233346. 5) Pack Number AMS16278, UDI B098AMS162780, Lot Numbers: 219872, 222999, 226497, 229309, 236465, 237544, 238613. 6) Pack Number AMS16499, UDI B098AMS164990, Lot Numbers: 215711, 218234, 224253, 226168, 226627, 227667, 228446, 230422, 233097, 233399, 233960, 234577, 234907, 236220, 236852, 237358, 238563, 239114, 240373, 241010, 241717. 7) Pack Number AMS16709, UDI B098AMS167090, Lot Numbers: 223361, 225039, 236666, 240344, 241412. 8) Pack Number AMS17336, UDI B098AMS173360, Lot Numbers: 233541, 240967. 9) Pack Number AMS17945, UDI B098AMS179450, Lot Numbers: 235478, 240779, 241565. 10) Pack Number AMS17946, UDI B098AMS179460, Lot Numbers: 235954, 239092, 241514. 11) Pack Number AMS3150F, UDI B098AMS3150F0, Lot Numbers: 211888, 216076, 216357, 218443, 219827, 221799, 223766, 227324, 228151, 229404, 229717, 230623, 231694, 233211, 234586, 234763, 236581, 241332. 12) Pack Number AMS3150G, UDI B098AMS3150G0, Lot Numbers: 242374. 13) Pack Number AMS5451D, UDI B098AMS5451D0, Lot Numbers: 222621, 224568, 238089, 238575, 242113. 14) Pack Number AMS9771, UDI B098AMS97710, Lot Numbers: 176784, 179837, 181956, 184890, 191784, 194017, 196708, 197543, 199137, 201956, 210134, 215434, 217352, 218696, 225332, 226657, 228224, 228678, 230472, 233592, 235614, 236684, 241927.
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 8, 2026

Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

ALL 50 STATES
Full report

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

Recall #:
99301
Lot/product code:
DYNJ68477L UDI-DI 10198459487866 Lots 25HMF458 25LME235 DYNJ68477M UDI-DI 10198459678738 Lots 26CMK219 26EMG622
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 7, 2026

Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31

Failed Impurities/Degradation Specifications

ALL 50 STATES
Full report

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

Recall #:
D-0662-2026
Lot/product code:
Lot #: 7000612A, Exp. Date 1/2028
Recalling firm:
ONESOURCE SPECIALTY PHARMA LIMITED
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 5, 2026

Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10

Failed Dissolution Specifications

ALL 50 STATES
Full report

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

Recall #:
D-0610-2026
Lot/product code:
[100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
Recalling firm:
Inventia Healthcare Limited
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 5, 2026

Optima XR200amx, Mobile Digital-Ready Radiographic System

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

ALL 50 STATES
Full report

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

Recall #:
99279
Lot/product code:
UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 5, 2026

OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.

The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.

ALL 50 STATES
Full report

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

Recall #:
99193
Lot/product code:
Product Code 3032, UDI 10381780268468; Product Code 3055, UDI 10381780268505; Product Code 3069, UDI 10381780268512; Product Code 3076, UDI 10381780268529; Product Code 3086, UDI 10381780268536; Product Code 3092, UDI 10381780268550; Product Code 3093, UDI 10381780268567; Product Code 3096, UDI 10381780268581; Product Code 3098, UDI 10381780268598; Product Code 3099, UDI 10381780268604; Product Code 3133, UDI 10381780268680; Product Code 3137, UDI 10381780268697; Product Code 3142, UDI 10381780268710; Product Code 3146, UDI 10381780268734; Product Code 3148, UDI 10381780268758; Product Code 3176, UDI 10381780268826; Product Code 3177, UDI 10381780268833; Product Code 3185, UDI 10381780268857; Product Code 3201, UDI 10381780268871; Product Code 3203, UDI 10381780268888; Product Code 3216, UDI 10381780268895; Product Code 3217, UDI 10381780268901; Product Code 3218, UDI 10381780268918; Product Code 3219, UDI 10381780268925; Product Code 3220, UDI 10381780268932; Product Code 3274, UDI 10381780268994; Product Code 3312, UDI 10381780269038; Product Code 3335, UDI 10381780269045; Product Code 3336, UDI 10381780269052; Product Code 3342, UDI 10381780269076; Product Code 3343, UDI 10381780269083; Product Code 3391, UDI 10381780269168; Product Code 3398, UDI 10381780269212; Product Code 3424, UDI 10381780269243; Product Code 3426, UDI 10381780269250; Product Code 3483, UDI 10381780269267; Product Code 3485, UDI 10381780269274; Product Code 3520, UDI 10381780282273; Product Code 3529, UDI 10381780269281; Product Code 3530, UDI 10381780269298; Product Code 3531, UDI 10381780269304; Product Code 3532, UDI 10381780269311; Product Code 3533, UDI 10381780269328; Product Code 3534, UDI 10381780269335; Product Code 3535, UDI 10381780269342; Product Code 3536, UDI 10381780269359; Product Code 3537, UDI 10381780269366; Product Code 3555, UDI 10381780269373; Product Code 3557, UDI 10381780269380; Product Code 3565, UDI 10381780269397; Product Code 3570, UDI 10381780269403; Product Code 3575, UDI 10381780269410; Product Code 3586, UDI 10381780269427; Product Code 3588, UDI 10381780269434; Product Code 3590, UDI 10381780269441; Product Code 3592, UDI 10381780269458; Product Code 3593, UDI 10381780269465; Product Code 3594, UDI 10381780269472; Product Code 3595, UDI 10381780269489; Product Code 3596, UDI 10381780269496; Product Code 3597, UDI 10381780269502; Product Code 3601, UDI 10381780269519; Product Code 3602, UDI 10381780269526; Product Code 3603, UDI 10381780269533; Product Code 3604, UDI 10381780269540; Product Code 3605, UDI 10381780269557; Product Code 3610, UDI 10381780269564; Product Code 3614, UDI 10381780269571; Product Code 3616, UDI 10381780269588; Product Code 3618, UDI 10381780269595; Product Code 3620, UDI 10381780269601; Product Code 3622, UDI 10381780269618; Product Code 3623, UDI 10381780269625; Product Code 3624, UDI 10381780269632; Product Code 3626, UDI 10381780269649; Product Code 3630, UDI 10381780269656; Product Code 3631, UDI 10381780269663; Product Code 3635, UDI 10381780269670; Product Code 3640, UDI 10381780269687; Product Code 3647, UDI 10381780269694; Product Code 3650, UDI 10381780269700; Product Code 3654, UDI 10381780202936¿; Product Code 3700, UDI 10381780269717; Product Code 3720, UDI 10381780269724; Product Code 3732, UDI 10381780269731; Product Code 3740, UDI 10381780269748; Product Code 3759, UDI 10381780269755; Product Code 3761, UDI 10381780269762; Product Code 3763, UDI 10381780269779; Product Code 3765, UDI 10381780269786; Product Code 3772, UDI 10381780269793; Product Code 3774, UDI 10381780269809; Product Code 3780, UDI 10381780269816; Product Code 3782, UDI 10381780269823; Product Code 3784, UDI 10381780269830; Product Code 3786, UDI 10381780269847; Product Code 3788, UDI 10381780269854; Product Code 3790, UDI 10381780269861; Product Code 3792, UDI 10381780269878; Product Code 3794, UDI 10381780269885; Product Code 3796, UDI 10381780269892; Product Code 3798, UDI 10381780269908; Product Code 3800, UDI 10381780269915; Product Code 3812, UDI 10381780269960; Product Code 3814, UDI 10381780269977; Product Code 3816, UDI 10381780269984; Product Code 3824, UDI 10381780270027; Product Code 3842, UDI 10381780270034; Product Code 3848, UDI 10381780270041; Product Code 3860, UDI 10381780270089; Product Code 3862, UDI 10381780270096; Product Code 3864, UDI 10381780270102; Product Code 3870, UDI 10381780270133; Product Code 3872, UDI 10381780270140; Product Code 3874, UDI 10381780270157; Product Code 3886, UDI 10381780270218; Product Code 3888, UDI 10381780270225; Product Code 3890, UDI 10381780270232; Product Code 3892, UDI 10381780270249; Product Code 3900, UDI 10381780270256; Product Code 3909, UDI 10381780270294; Product Code 3910, UDI 10381780270300; Product Code 3911, UDI 10381780270317; Product Code 3914, UDI 10381780270324; Product Code 3915, UDI 10381780270331; … (truncated, 26108 characters total — see the official FDA record for the full value)
Recalling firm:
Integra LifeSciences Corp. (NeuroSciences)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 5, 2026

Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.

Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.

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Full report

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

Recall #:
99126
Lot/product code:
Model Number: 867232. UDI-DI: (01)00884838102842. Software Version Number: 4.0.0.0. Serial Numbers: US001A002F, US001A00AW, US001A00C9, US001A00EW, US001A00F0, US001A00GM, US001A00N4, US001A00PB, US001A00PZ, US001A00R1, US001A00UE, US001A00VU, US001A00Z4, US001A013T, US001A018A, US001A018R.
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 5, 2026

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

ALL 50 STATES
Full report

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

Recall #:
99106
Lot/product code:
UDI/DI: 04953170441271, Lot Numbers: H2530 or later
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 5, 2026

Optima XR220amx, Mobile Digital-Ready Radiographic System

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

ALL 50 STATES
Full report

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

Recall #:
99279
Lot/product code:
UDI-DI: 00840682115261; System IDs: 05249MOB02.OLD, 205820DP1, 228818XR220, 229276M1, 240566P1, 301295OPTIMA2, 303788SBOPT1, 314251P5, 352LEEDP1, 386FLGDPXR3, 417347DPORT1, 512SAMCSB, 516632OPTIMA2, 540981ODP7, 563264OPT, 601445DP1, 615338HDP01, 661949DP2, 713441OPCDX1, 717657OPT1, 718206OPT240A, 727848SB1, 732321DP1, 757736DP3, 813302OPT1, 828213DXP1, 828286OPT1, 843847220D, 850070941, 865545DP3, 915821OPT1, 941342OP221, 972566XR220E, 985447TM4, SA1208MM05, SB2201700085WK, XR1034798WK7, XR1037005WK4
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 5, 2026

Optima XR240amx, Mobile Digital Radiographic System

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

ALL 50 STATES
Full report

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

Recall #:
99279
Lot/product code:
UDI-DI: 00840682122351 and 00840682123686; System IDs: 252847PP249, 281MSL2402, 291OPTI1, 312CCHSUPER7, 318487OPTIMA1, 360744OPT2402, 501686OPTI1, 504826XR241, 519941XR240A, 540776ODP3, 541472M4, 602344240C, 706291BEE9, 713799XR240, 770836BEE2, 813872OPT11, 813872OPT9, 843724OPT1, 843847OPT240, 870239OPT2, 905522AMX240, 973625DIG4, DF2402001002WK, SA1013MM13
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 4, 2026

Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

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Full report

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

Recall #:
D-0583-2026
Lot/product code:
Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027.
Recalling firm:
Breckenridge Pharmaceutical, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 4, 2026

Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

ALL 50 STATES
Full report

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

Recall #:
D-0582-2026
Lot/product code:
Lot: 241180C, Exp. Date April 2027.
Recalling firm:
Breckenridge Pharmaceutical, Inc.
View official FDA record (opens in a new tab)