BIGNOPE
Ko-fi

Recalls affecting Alabama

Data last updated: September 9, 2026 at 1:18 PM UTC

16,873 recalls found
NewOld
High RiskLow Risk
AllClear

Just announced

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

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

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled March 27, 2026

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

X-Ray generator may malfunction resulting in the X-Ray being inoperable.

ALL 50 STATES
▸Full report

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

Recall #:
98644
Lot/product code:
Lot Code: Refer to product traceability spreadsheet provided MXU-RV71 UDI: (01)09357123000051/ Serial Numbers: 334 397 399 408 423 425 459 MXU-RV35 UDI: (01)09357123000037/ Serial Numbers: 269 223 349 348 351 363 388 384 391 359 416 419 428 429 430 431 435 434 436 413 437 438 460 461 462
Recalling firm:
Micro-X Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 27, 2026

Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

Includes an incorrect screw seat interface.

ALAZFLHILAMDOHVA
▸Full report

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

Recall #:
98681
Lot/product code:
Article 010.0304. UDI: (01)07630031779977(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00811_00_b00, 28000US_00811_01_b00, 28000US_00426_00_b00, 28000US_00449_00_b00, 28000US_01266_00_b00.
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 27, 2026

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

ALL 50 STATES
▸Full report

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

Recall #:
98633
Lot/product code:
All Lots/UDI:0690103D004EVD000V5
Recalling firm:
Edwards Lifesciences, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 27, 2026

Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments

Includes an incorrect screw seat interface.

ALAZFLHILAMDOHVA
▸Full report

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

Recall #:
98681
Lot/product code:
Article 010.0158. UDI: (01)07630031759764(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00622_00_b00, 28000US_00431_00_b00, 28000US_00489_00_b00, 28000US_00792_00_b00, 28000US_00908_00_b00, 28000US_00908_01_b00.
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 27, 2026

Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.

CGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

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-0420-2026
Lot/product code:
Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.
Recalling firm:
Appco Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 27, 2026

Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.

CGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

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-0419-2026
Lot/product code:
Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN.
Recalling firm:
Appco Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 27, 2026

Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.

CGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

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-0421-2026
Lot/product code:
Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. .
Recalling firm:
Appco Pharma LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A

Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).

ALL 50 STATES
▸Full report

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

Recall #:
98722
Lot/product code:
Model/Catalog Number: 91496 UDI-DI Code: (01)10841522106422 Serial Numbers: 1496-224669 1496-224670 1496-224657 1496-224658 1496-224659 1496-224660 1496-224661 1496-224671 1496-224673 1496-224674 1496-224675 1496-224676 1496-224677 1496-224678 1496-224679 1496-224680 1496-224681 1496-224682 1496-224683 1496-224684 1496-224685 1496-224686 1496-224687 1496-224688 1496-224689 1496-224690 1496-224691 1496-224692 1496-224693 1496-224694 1496-224695 1496-224696 1496-224697 1496-224698 1496-224699 1496-224701 1496-224702 1496-224703 1496-224704 1496-224705 1496-224706 1496-224707 1496-224708 1496-224709 1496-224710 1496-224711 1496-224712 1496-224713 1496-224714 1496-224715 1496-224716 1496-224664 1496-224665 1496-224666 1496-224667 1496-224668
Recalling firm:
Spacelabs Healthcare, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis

Neutralization Buffer may contain contaminants

ALL 50 STATES
▸Full report

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

Recall #:
98702
Lot/product code:
Lot: F5061154/UDI: 00816387021091
Recalling firm:
Immuno-Mycologics, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

ALL 50 STATES
▸Full report

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

Recall #:
98738
Lot/product code:
UDI-DI: 00840682146616; Serial Numbers: REV2A2200014CN REV2A2200072CN REV2A2100016CN REV2A2200068CN REV2A2200034CN REV2A2200116CN REV2A2200037CN REV2A2000006CN REV2A2200041CN REV2A2100011CN REV2A2100048CN REV2A2200015CN REV2A2100038CN REV2A2200011CN REV242200002CN REV2A2200120CN REV2A2200018CN REV2A2300016CN REV2A2200067CN REV2A2000007CN REV2A2200105CN REV2A2200007CN REV2A2000032CN REV2A2100019CN
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 26, 2026

Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

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-0484-2026
Lot/product code:
Batch # FD253967, Exp Date: 06/26/2027
Recalling firm:
Hetero Labs Limited (Unit V)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

ALL 50 STATES
▸Full report

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

Recall #:
98738
Lot/product code:
UDI-DI: 00195278502179; Serial Numbers: REV282400012CN REV282400006CN REV282400038CN REV282400011CN REV282400003CN REV282400013CN REV282300006CN REV282400021CN REV282300013CN REV282400035CN REV282300022CN
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

ALL 50 STATES
▸Full report

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

Recall #:
98738
Lot/product code:
UDI-DI: 00840682146173; Serial Numbers: AS10G2200136YC AS10G2200101YC AS10G2200068YC AS10G2200035YC AS10G2300093YC AS10G2400094YC AS10G2400079YC AS10G2100008YC AS10G2500002YC CBDWG2400019HM CBDWG2300081HM AS10G2400056YC AS10G2400081YC AS10G2400087YC CBDWG2400117HM CBDWG2400085HM CBDWG2500003HM CBDWG2400140HM CBDWG2400126HM AS10G2200085YC AS10G2300057YC CBDWG2500011HM CBDWG2300056HM CBDWG2300041HM AS10G2300041YC
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

ALL 50 STATES
▸Full report

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

Recall #:
98738
Lot/product code:
UDI-DI: 00195278460271; Serial Numbers: REV2X2400067CN REV2X2400065CN REV2X2400046CN REV2X2400021CN REV2X2400050CN REV2X2400095CN REV2X2400078CN REV2X2300068CN REV2X2400093CN REV2X2400098CN REV2X2300091CN REV2X2300042CN REV2X2300083CN REV2X2300020CN REV2X2400068CN REV2X2400107CN REV2X2300090CN REV2X2300097CN REV2X2300003CN REV2X2400028CN REV2X2400026CN REV2X2300002CN REV2X2400027CN REV2X2400059CN REV2X2300084CN REV2X2400069CN REV2X2400063CN REV2X2400055CN REV2X2300011CN REV2X2300050CN REV2X2400048CN REV2X2300047CN REV2X2400014CN
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

ALL 50 STATES
▸Full report

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

Recall #:
98738
Lot/product code:
UDI-DI: 00195278469700; Serial Numbers: REV242400001CN REV242400004CN REV242300006CN REV242400002CN REV242300004CN
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

ALL 50 STATES
▸Full report

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

Recall #:
98738
Lot/product code:
UDI-DI: 00840682123471; Serial Numbers: REVV82200058CN REVV82200046CN REVV82100016CN REVV82200014CN REVV82100027CN REVV82200047CN REVV82100031CN REVV82400010CN REVV82200017CN REVV82400005CN
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

ALL 50 STATES
▸Full report

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

Recall #:
98738
Lot/product code:
UDI-DI: 00840682118552; Serial Numbers:REVVX2300007CN 443327CN2 REVVX1600034CN REVVX2400004CN REVVX2200047CN 441716CN8 00000440713CN6 REVVX1800043CN 441839CN8 REVVX1700067CN REVVX1800007CN REVVX1800105CN REVVX1800048CN REVVX1900123CN REVVX1800046CN REVVX2000005CN REVVX2200009CN REVVX1600013CN REVVX1700101CN REVVX2200025CN REVVX2100028CN REVVX1900069CN REVVX2100020CN REVVX2100014CN REVVX2100050CN REVVX1600052CN 438902CN9 REVVX1900107CN 438369CN1 REVVX1900018CN REVVX1700071CN REVVX1700082CN 442792CN8 REVVX2200007CN REVVX1700104CN REVVX2000056CN REVVX1900086CN REVVX2200039CN
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

ALL 50 STATES
▸Full report

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

Recall #:
98544
Lot/product code:
Model Number: MAJ-2113. UDI Number: 04953170404085. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 22A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

ALL 50 STATES
▸Full report

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

Recall #:
98544
Lot/product code:
Model Number: MAJ-2114. UDI Number: 04953170404092. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

ALL 50 STATES
▸Full report

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

Recall #:
98544
Lot/product code:
Model Number: MAJ-2330. UDI Number: 04953170404207. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

Heraeus, PALAMIX uno. Material Number: 66057893.

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).

ALL 50 STATES
▸Full report

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

Recall #:
98608
Lot/product code:
Material Number: 66057893; UDI-DI: 04260102133587; Batch: all batches with numbers below 223060;
Recalling firm:
Heraeus Medical GmbH (Dental Division)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.

Xxx

ALL 50 STATES
▸Full report

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

Recall #:
98544
Lot/product code:
Model Number: MAJ-2115. UDI Number: 04953170404108. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 51A.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

Resorbable bone void filler falls outside standard specifications.

ALL 50 STATES
▸Full report

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

Recall #:
98733
Lot/product code:
UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
Recalling firm:
Orthorebirth Co Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27

Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.

ALL 50 STATES
▸Full report

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

Recall #:
98660
Lot/product code:
Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250429(17)280429(10)M47331 Lot Number: M47331 Expiration Date: 04/29/2028 Model No: DVF4034-27 UDI-DI: (01)1081748902557(11)250527(17)280527(10)M48044 Lot Number: M48044 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250610(17)280610(10)M48163 Lot Number: M48163 Expiration Date: 06/10/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M47612 Lot Number: M47612 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250617(17)280617(10)M48071 Lot Number: M48071 Expiration Date: 06/17/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250610(17)280610(10)M48164 Lot Number: M48164 Expiration Date: 06/10/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48470 Lot Number: M48470 Expiration Date: 06/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48471 Lot Number: M48471 Expiration Date: 06/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M48043 Lot Number: M48043 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M47611 Lot Number: M47611 Expiration Date: 05/27/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48472 Lot Number: M48472 Expiration Date: 06/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250709(17)280709(10)M48658 Lot Number: M48658 Expiration Date: 07/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250709(17)280709(10)M48657 Lot Number: M48657 Expiration Date: 07/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250807(17)280807(10)M49169 Lot Number: M49169 Expiration Date: 08/07/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250806(17)280806(10)M49170 Lot Number: M49170 Expiration Date: 08/06/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250819(17)280819(10)M49287 Lot Number: M49287 Expiration Date: 08/19/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250825(17)280825(10)M49777 Lot Number: M49777 Expiration Date: 08/25/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250825(17)280825(10)M49776 Lot Number: M49776 Expiration Date: 08/25/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49830 Lot Number: M49830 Expiration Date: 08/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49831 Lot Number: M49831 Expiration Date: 08/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49907 Lot Number: M49907 Expiration Date: 08/26/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250904(17)280904(10)M49906 Lot Number: M49906 Expiration Date: 09/04/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250909(17)280909(10)M49925 Lot Number: M49925 Expiration Date: 09/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250909(17)280909(10)M49926 Lot Number: M49926 Expiration Date: 09/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50538 Lot Number: M50538 Expiration Date: 10/03/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50628 Lot Number: M50628 Expiration Date: 10/03/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50629 Lot Number: M50629 Expiration Date: 10/03/2028 Model No:DVF4034-27 UDI-DI: (01)10817489025557(11)251008(17)281008(10)M50897 Lot Number: M50897 Expiration Date: 10/08/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251008(17)281008(10)M50898 Lot Number: M50898 Expiration Date: 10/08/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251007(17)281007(10)M50678 Lot Number: M50678 Expiration Date: 10/07/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251015(17)281015(10)M50917 Lot Number: M50917 Expiration Date: 10/15/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251017(17)281017(10)M50932 Lot Number: M50932 Expiration Date: 10/17/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251107(17)281107(10)M50993 Lot Number: M50993 Expiration Date: 11/07/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251113(17)281113(10)M51034 Lot Number: M51034 Expiration Date: 11/13/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51076 Lot Number: M51076 Expiration Date: 12/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51077 Lot Number: M51077 Expiration Date: 12/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51131 Lot Number: M51131 Expiration Date: 12/09/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251212(17)281212(10)M51235 Lot Number: M51235 Expiration Date: 12/12/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251212(17)281212(10)M51236 Lot Number: M51236 Expiration Date: 12/12/2028 Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251218(17)281218(10)M51292 Lot Number… (truncated, 5790 characters total — see the official FDA record for the full value)
Recalling firm:
Katalyst Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

ALL 50 STATES
▸Full report

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

Recall #:
98660
Lot/product code:
Lot Code: Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250422(17)280422(10)M47116 Lot Number: M47116 Expiration Date: 04/22/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250610(17)280610(10)M48162 Lot Number: M48162 Expiration Date: 06/10/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250618(17)280618(10)M48276 Lot Number: M48276 Expiration Date: 06/18/2028 Model No: DVF4034-35 UDI-DI: (01)10817489025540(11)250626(17)280626(10)M48303 Lot Number: M48303 Expiration Date: 06/26/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250730(17)280730(10)M49168 Lot Number: M49168 Expiration Date: 07/30/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250807(17)280807(10)M49270 Lot Number: M49270 Expiration Date: 08/07/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250819(17)280819(10)M49285 Lot Number: M49285 Expiration Date: 08/19/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250819(17)280819(10)M49286 Lot Number: M49286 Expiration Date: 08/19/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250825(17)280825(10)M49775 Lot Number: M49775 Expiration Date: 08/25/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250825(17)280825(10)M49829 Lot Number: M49829 Expiration Date: 08/25/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250826(17)280826(10)M49905 Lot Number: M49905 Expiration Date: 08/26/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250917(17)280917(10)M50289 Lot Number: M50289 Expiration Date: 09/17/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250917(17)280917(10)M50208 Lot Number: M50208 Expiration Date: 09/17/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)250924(17)280924(10)M50290 Lot Number: M50290 Expiration Date: 09/24/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251015(17)281015(10)M50916 Lot Number: M50916 Expiration Date: 10/15/2028 Model No:DVF4034-25 UDI-DI: (01)10817489025540(11)251020(17)281020(10)M50992 Lot Number: M50992 Expiration Date: 10/20/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251023(17)281023(10)M51033 Lot Number: M51033 Expiration Date: 10/23/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251029(17)281029(10)M51074 Lot Number: M51074 Expiration Date: 10/29/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251029(17)281029(10)M51075 Lot Number: M51075 Expiration Date: 10/29/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251113(17)281113(10)M51234 Lot Number: M51234 Expiration Date: 11/13/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251125(17)281125(10)M51290 Lot Number: M51290 Expiration Date: 11/25/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251126(17)281126(10)M51291 Lot Number: M51291 Expiration Date: 11/26/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)251209(17)281209(10)M51521 Lot Number: M51521 Expiration Date: 12/09/2028 Model No:DVF4034-25 UDI-DI: (01)10817489025540(11)251218(17)281218(10)M51628 Lot Number: M51628 Expiration Date: 12/18/2028 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)260120(17)290120(1)M51698 Lot Number: M51698 Expiration Date: 01/20/2029 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)260203(17)290203(10)M51893 Lot Number: M51893 Expiration Date: 02/03/2029 Model No: DVF4034-25 UDI-DI: (01)10817489025540(11)260203(17)290203(10)M52019 Lot Number: M52019 Expiration Date: 02/03/2029
Recalling firm:
Katalyst Surgical, LLC
View official FDA record (opens in a new tab)