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Recalls affecting Puerto Rico

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

16,293 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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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)
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)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced 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 November 3, 2025

Gut Microbiome Test Large

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785893; SKU: A130; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Intestinal Worms Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785978; SKU: 2A169; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Neurotransmitters Plus

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612786449; SKU: F510; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Pet Allergy Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785695; SKU: TI; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

DHEA Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612786418; SKU: O320; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.

ALL 50 STATES
Full report

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

Recall #:
98001
Lot/product code:
ViewPoint 6 version 6.15.3, UDI (01)00195278753472(10)ViewPoint6.15.3.0, System ID numbers: F0HD Y23W, TR41 MQHH, MMZR D4YS, YJJM BH20, 02GQ KX8N, Y13Z CK8A, 215K QT2P, R2RQ 6S9K, 3SD3 XRBX, 64TY MCQ5, SU3C 35BJ, FURE QR5U, 493M 8J65, E206 FXM2, 0QN8 K9Z5, 2PM0 2G22, Y3EK ZG4H, XM7F JE94, T-XQH5 RGGW, JXAK BGRN, X563 55KC, Q759 NQ3T, YUC5 E1B7, M4DN P5QT, HJU6 59Y2, PXDU YRPA, XDRU PP57, GA26 M2DT, 7QZY K6XB, FH9H X5S1, HH3Y Y4W3, R4JZ 668A, 8E00 EY8A, BSB4 FJDK, T-BSB4 FJDK, CR6U 0AQ1, 20XB 0UAS, SKSK 3JNJ, KUT3 2W8P, 7H6Q RE0Z, 5KDZ 640J, 1M4R 8H6R, T-KN5N NE40, KN5N NE40, 576N X8R0, B8R9 HHAP, NFG0 C3GZ, R546 M5JW, T-R546 M5JW, 959J 7955, CCZ5 BXGJ, AXDF 5QS9, 73C8 M5NZ, GZZ6 R27Y, PT24 XDAM, EMUP X20W, 1J2C FXHS, T-1J2C FXHS, 3DUC WYDK, TG21 RSW3, 6XUS 9XCZ, M4CF 0WQ5, ERYR WQER, HKWC SUYQ, AC6A YG37, GC11 B3UG, UMXB HG5Z, T-B26E J931, 947H U85K, Q7PY 5WN5, PSUP PUC9, BEFY R4UN, 43MK TD9D, RS9S A4R2, U6BE 5BX6, 59EZ 9872, C9UY 3KDK, F9B2 8MRB, Z7X5 H282, X5G6 76RS, M32Q Z36T, A65S 86WP, CMNA RFPH, T-KA2Y 4HY3, T-YA80 ZX5C, T-8FFF PD4M, T-36Z7 UAS5, WYQ8 PCK1, T-Y9EP 31QZ, 4F2C Y3PQ, T-F8NN MB9J, HH64 GRKC, 0UWX FH6R, RJPJ R5R6, UWWH ZMHN, XXY0 AR3T, ME61 Z278, 49RT 5QXB, F6B9 CS51, 42WG 8946, CZSC DJ7B, E53Q DS7F, 1JU9 764P, 0G4S UA94, EN2K 6QM6, YDDG 0HJ1, QTR8 1F3J, 59D5 WJAS, W15C GMAH, HDAX CJKK, SZ8Z W9CZ, QNTU 134G, 8QKN 3HQ4, HMZC M3EK, PJGR 9JDD, 28NM WM72, 0HFE QU9U, 511S JXX6, TAM7 HWSE, 1T2S ZW22, PF3Z RMAG, G3NQ TWAP, JN9B 6APN, 2MDC 9MWA, 1Y1G 94YN, 4XZZ KC8B, 8HCM KAJU, XB8R QBMF, UDYP DZE4, B14H GDSJ, E9A3 269U, TTZ3 Z4UY, PNEU ZHUQ, J4EJ YB8H, 4URW UZ55, YN9U B32G, ZFBJ BQZ5, 9XW2 TE1P, 52Z8 M434, PMPB 18G7, 1RCW 57FH, KNG0 138F, D9YM 7W9K, 5CHB 7TM0, EUXC F39D, CEUC FQMM, DMSA TCBK, KYRJ HRH0, A49C 21EZ, XNAJ CJE9, 5J7X S8CK, 0AAT NXA6, T-AMSW JGDT, UW9Z UJJE, 48G5 G35J, BUB3 GCKX, 768U JTY3, 014W 0ANZ, 972P P394, C77B 383C, 00FE KG9W, QJ2A 46EU, TBE9 WHZZ, 2EQ5 NW10, 66CU 95EK, D6PA 1TQC, 4N9H UQT2, 5JS5 X6CX, GRJE RZNX, TK1J 029D, TKBK EFM3, GEP7 ACU0, K12C 58ZJ, QG0C F2UP, QJTF 1M4Y, RZ9C M8ED, X7ST 2C9X, TMSD RXA0, RHTJ H2SK, 42PW D86W, BGYU A83K, R0AX FKSC, WG1R 0QN5, ZEWE NF5R, F8PN R6TQ, 8APM Q8FA, 955U TZJW, GDB3 529E, 32JJ 2AM2, 81K3 Z3QW, XRJT 0QDT, JET1 CBS4, XYN4 W6Q9, 5BM8 MJDZ, CGXG R66Z, M1Q0 RBCT, GYD2 0Q0U, 8DXQ 7QSR, 4D82 S2F6, WHFZ CR80, TT5C 7N3D, 0EUK ND51, NDJD D5S4, 401Z KBMF, 7FHF 61F2, NT2D 0T0W, 6GHQ Q7GR, 6320 8C6E, 14E3 BWFM, Z9WU JS31, UG7R HRJE, HTMN N373, KWW1 YAFA, 7QWY 5A07, M3YG FF5W, YABG C7A0, WRAT 4937, XD1R X7KD, TQSU 0T1Q, 76HS CBDT, HKTK EHE4, Z59W SYC9, Q9U9 KSP0, 4ERF S95C, 7Q6K R45W, FUF7 UMQ7, KJ8Z MJEK, S6YC HNRB, TTD3 2U59, EHBZ HTNW, EZEY 7R72, REB1 B9PB, AJRT YXMG, Z9BK 4WRN, TZJ7 F2KZ, WD6M 8A95, 9ZB3 WB6D, 0K4S UD5X, SU9Q 53RN, 87WB WRKZ, 3FDG P9P8, 44MC 7BE9, HFXD SKG7, C4WQ NZMN, JUP9 MPN7, 7YA1 DASU, HWX0 TDZT, MDJY ZCHM, U6JA YUNK, UXC7 95YY, XURH D464, U6MK HHJ7, E2EF 3WGC, X0Z3 6AFB, Y5K6 704A, 3NAU FFRM, KWYM 8PJ5, CMTU 2BGW, 24ZG C3UB, YZPN WQPA, 1XZS XPFQ, 1Y77 4TSJ, WGG3 8D2Y, KXU8 ESHS, 22RW 8AZ7, E9XE E1PF, TNPZ 8CS1, YN6H 9CKT, Z5M5 GCF2, 1YKC XSH3, CT5B WERM, TXR6 3Z91, EZAW MGUG, 0MH9 MG6W, YM3Q NP88, GDC3 DEAQ, JTD0 AMUY, K64R DGF0, E8G4 6ZTS, 35CX GPB5, JBKW 4GY3, UGDC YUCT, HJ00 AJEK, WAZQ 0ACX, 7KAM Q76W, 7EBS A7NJ, SMCT P6DD, QFSM 73TQ, Z7Y5 1XBD, FEDA F8KK, RJY1 37YA, J2JF HGZD, UPR1 GPRY, Z590 RKN4, 9AAZ 75MS, SWXJ BK55, G0NP BH8N, K8ZY TCJK, JNCM DT51, J9G7 KKRA, KB67 K0GZ, 09YR 9WP2, MJ1F XM10, 3EZT PGT3, 5BMJ CRPM, R7DD QX6U, EB0A SHR0, KAS3 CZNJ, Y3ZQ ABN1, EWHB 8DNW, EYKC Q49C, A1AR R36D, MWM9 DRYM, 1ZEA MR88, 97Q1 0CJ4, ZN45 M7MA, 1KTM 04D4, 0YY9 AXJZ, WCKW GYF0, 6QUB C41Q, Z86G S0GT, H5JF M412, H5Q8 E6CJ, U46J F79Z, JGJP EKCE, 8U4Z 2634, P30D 9N83, 73EY 59JR, EPMZ FXRF, 7DGA 0MPM, 7BZ2 61US, J0SX PG2M, WWM5 FY13, UBBA 0RFY, 0J8J UATM, CTRD NXWS, XQQF R6YP, QD0A G7F0, T1WY YHUM, W3NZ 9N3X, ZYSJ J7EU, UZZ0 EMCJ, WR4T 8Y8Y, YFW1 QNDR, 3Y7T MRSX, CU2Y ZY3Z, HM8N 2NYY, P54P SD7Q, Z5ZF EFHQ, AJGJ 5B69, 4XJC 152P, 9R09 GY3K, NCYE ETCE, 23QT 52HF, W309 4DEW, XJK8 954Q, 9DDD X3UF, 5H73 7WET, 1NNZ XWH8, QHFR SW9U, 6TSR R4M3, R4S9 J8Z7, Q544 MZYN, JDAA SDUM, 5JUQ 9HM6, Y98Q H3G5, BASF X8BT, 2HWY 8EYP, 03ES YU91, AED6 PM95, 030F DAST, WJFJ 4J1B, JBF8 B00R, YSNJ J13E, Y0XB 8UFQ, 70EX MTK9, 4H9G 1007, 62SD J1NW, 8R9U 0WKX, 90XR DR3Z, 7J0Y JNT8, 6FWJ BTS1, DQ6B 57ND, Y3GP TF6T, U7JU TN0X, 219X MM0W, 3ABR 9E4N, 8D9A RC5E, URE4 BTBD, JCXT 5ZAA, W3HA RWNT, 165J B239, BGF4 RQEK, YC7Q P4SU, 5DSH F0CE, XCCM 7JNK, FEQM 9SMA, KCHP 4ASC, 2ZGP UUTY, A80G WJP0, 43C3 MB9J, SP66 U12H, BCX3 5QT8, D8UZ 7X07, A2CZ CBW0, BHPR ZBE7, 5RCA DN8Y, 5BG3 BMXG, J413 GSQ7, QJU2 BY9E, Z5AN 81U0, 44Z3 JGM0, CP3W WJZZ, ECS0 29GZ, 1SSJ 38H0, 6ZUR HAG5, 00ED MET0, AEMA DC6D, 55CW D6BJ, 4PR1 HXD5, 4Q8B WA20, YMEF T97G, 8JHX EDCD, Y923 F5YG, E0M7 7XKJ, HHTT A5RA, AKS5 XS4M, 9E27 KPJR, SD6H KPPH, RNBR 6FCR, EEKG KEG7, GPZT 8BPF, NHBS G3AG, XRWC 9CKK, 2N2Q RJZ5, 9P0B AA31, 985G 78WA, 0Y48 F5HS, QXBX Z8BZ, YT9A T373, WBZX 4W0Z, 93UZ 4H2B, TXFK 409C, 93Y9 CFG… (truncated, 13656 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

ALL 50 STATES
Full report

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

Recall #:
97939
Lot/product code:
Model Number: LVP-0004. UDI-DI: 00811505030320.
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

2 in 1 Trichomonas / Gardnerella Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221700925; SKU: B-TOG; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Parasite Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612786425; SKU: 2A178; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Sperm Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221710221; SKU: VAN-SPE; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

HPV Antigen Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221708259; SKU: A-HPV; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Herpes (HSV-1 & HSV-2) Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221710047; SKU: A-HSV; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Alcohol (ALC) Test Saliva

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221708884; SKU: A-ALC-S; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic

Labeling contains claims that are not consistently present.

ALL 50 STATES
Full report

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

Recall #:
97862
Lot/product code:
Lot Code: All Lot Codes/ UDI: 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6209SP 18257200150588 37-6209SP 18257200150588 37-6209SP 18257200150588 37-6210SP 18257200150595 37-6210SP 18257200150595 37-6210SP 18257200150595 37-6211SP 18257200150601 37-6211SP 18257200150601 37-6211SP 18257200150601 37-6212SP 18257200150618 37-6212SP 18257200150618 37-6212SP 18257200150618 37-6306SP 18257200150915 37-6306SP 18257200150915 37-6306SP 18257200150915 37-6307SP 18257200150922 37-6307SP 18257200150922 37-6307SP 18257200150922 37-6308SP 18257200150939 37-6308SP 18257200150939 37-6308SP 18257200150939 37-6309SP 18257200150946 37-6309SP 18257200150946 37-6309SP 18257200150946 37-6310SP 18257200150953 37-6310SP 18257200150953 37-6310SP 18257200150953 37-6311SP 18257200150960 37-6311SP 18257200150960 37-6311SP 18257200150960 37-6312SP 18257200150977 37-6312SP 18257200150977 37-6312SP 18257200150977 37-7005SP 18257200150250 37-7005SP 18257200150250 37-7005SP 18257200150250 37-7006SP 18257200150267 37-7006SP 18257200150267 37-7006SP 18257200150267 37-7007SP 18257200150274 37-7007SP 18257200150274 37-7007SP 18257200150274 37-7008SP 18257200150281 37-7008SP 18257200150281 37-7008SP 18257200150281 37-7009SP 18257200150298 37-7009SP 18257200150298 37-7009SP 18257200150298 37-7010SP 18257200150304 37-7010SP 18257200150304 37-7010SP 18257200150304 37-7011SP 18257200150311 37-7011SP 18257200150311 37-7011SP 18257200150311 37-7012SP 18257200150328 37-7012SP 18257200150328 37-7012SP 18257200150328 37-7105SP 18257200149858 37-7105SP 18257200149858 37-7105SP 18257200149858 37-7106SP 18257200149865 37-7106SP 18257200149865 37-7106SP 18257200149865 37-7107SP 18257200149872 37-7107SP 18257200149872 37-7107SP 18257200149872 37-7108SP 18257200149889 37-7108SP 18257200149889 37-7108SP 18257200149889 37-7109SP 18257200149896 37-7109SP 18257200149896 37-7109SP 18257200149896 37-7110SP 18257200149902 37-7110SP 18257200149902 37-7110SP 18257200149902 37-7111SP 18257200149919 37-7111SP 18257200149919 37-7111SP 18257200149919 37-7112SP 18257200149926 37-7112SP 18257200149926 37-7112SP 18257200149926 37-7206SP 18257200150649 37-7206SP 18257200150649 37-7206SP 18257200150649 37-7207SP 18257200150656 37-7207SP 18257200150656 37-7207SP 18257200150656 37-7208SP 18257200150663 37-7208SP 18257200150663 37-7208SP 18257200150663 37-7209SP 18257200150670 37-7209SP 18257200150670 37-7209SP 18257200150670 37-7210SP 18257200150687 37-7210SP 18257200150687 37-7210SP 18257200150687 37-7211SP 18257200150694 37-7211SP 18257200150694 37-7211SP 18257200150694 37-7212SP 18257200150700 37-7212SP 18257200150700 37-7212SP 18257200150700 37-7306SP 18257200151004 37-7306SP 18257200151004 37-7306SP 18257200151004 37-7307SP 18257200151011 37-7307SP 18257200151011 37-7307SP 18257200151011 37-7308SP 18257200151028 37-7308SP 18257200151028 37-7308SP 18257200151028 37-7309SP 18257200151035 37-7309SP 18257200151035 37-7309SP 18257200151035 37-7310SP 18257200151042 37-7310SP 18257200151042 37-7310SP 18257200151042 37-7311SP 18257200151059 37-7311SP 18257200151059 37-7311SP 18257200151059 37-7312SP 18257200151066 37-7312SP 18257200151066 37-7312SP 18257200151066 37-8005SP 18257200150359 37-8005SP 18257200150359 37-8005SP 18257200150359 37-8006SP 18257200150366 37-8006SP 18257200150366 37-8006SP 18257200150366 37-8007SP 18257200150373 37-8007SP 18257200150373 37-8007SP 18257200150373 37-8008SP 18257200150380 37-8008SP 18257200150380 37-8008SP 18257200150380 37-8009SP 18257200150397 37-8009SP 18257200150397 37-8009SP 18257200150397 37-8011SP 18257200150410 37-8011SP 18257200150410 37-8011SP 18257200150410 37-8012SP 1825720015… (truncated, 8379 characters total — see the official FDA record for the full value)
Recalling firm:
Orthofix U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 12H;

Labeling contains claims that are not consistently present.

ALL 50 STATES
Full report

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

Recall #:
97862
Lot/product code:
Lot Code: All Lot Codes/ UDI: 38-2006SP 18257200151769 38-2007SP 18257200151776 38-2008SP 18257200151783 38-2009SP 18257200151790 38-2010SP 18257200151806 38-2011SP 18257200151813 38-2012SP 18257200151820 38-2013SP 18257200151837 38-2014SP 18257200151844 38-2106SP 18257200151875 38-2107SP 18257200151882 38-2108SP 18257200151899 38-2109SP 18257200151905 38-2110SP 18257200151912 38-2111SP 18257200151929 38-2112SP 18257200151936 38-2113SP 18257200151943 38-2114SP 18257200151950 38-2206SP 18257200151981 38-2207SP 18257200151998 38-2208SP 18257200152001 38-2209SP 18257200152018 38-2210SP 18257200152025 38-2211SP 18257200152032 38-2212SP 18257200152049 38-2213SP 18257200152056 38-2214SP 18257200152063 38-2309SP 18257200152094 38-2310SP 18257200152100 38-2311SP 18257200152117 38-2312SP 18257200152124 38-2313SP 18257200152131 38-2314SP 18257200152148 38-2508SP 18257200152360 38-2509SP 18257200152377 38-2510SP 18257200152384 38-2511SP 18257200152391 38-2512SP 18257200152407 38-2513SP 18257200152414 38-2514SP 18257200152421 38-3206SP 18257200152179 38-3207SP 18257200152186 38-3208SP 18257200152193 38-3209SP 18257200152209 38-3210SP 18257200152216 38-3211SP 18257200152223 38-3212SP 18257200152230 38-3213SP 18257200152247 38-3214SP 18257200152254 38-3409SP 18257200152285 38-3410SP 18257200152292 38-3411SP 18257200152308 38-3412SP 18257200152315 38-3413SP 18257200152322 38-3414SP 18257200152339 38-3506SP 18257200152759 38-3507SP 18257200152766 38-3508SP 18257200152773 38-3509SP 18257200152780 38-3510SP 18257200152797 38-3511SP 18257200152803 38-3512SP 18257200152810 38-3513SP 18257200152827 38-3514SP 18257200152834 38-3608SP 18257200152865 38-3609SP 18257200152872 38-3610SP 18257200152889 38-3611SP 18257200152896 38-3612SP 18257200152902 38-3613SP 18257200152919 38-3614SP 18257200152926 38-3706SP 18257200152957 38-3707SP 18257200152964 38-3708SP 18257200152971 38-3709SP 18257200152988 38-3710SP 18257200152995 38-3711SP 18257200153008 38-3712SP 18257200153015 38-3713SP 18257200153022 38-3714SP 18257200153039 38-3808SP 18257200153060 38-3809SP 18257200153077 38-3810SP 18257200153084 38-3811SP 18257200153091 38-3812SP 18257200153107 38-3813SP 18257200153114 38-3814SP 18257200153121 38-3908SP 18257200153152 38-3909SP 18257200153169 38-3910SP 18257200153176 38-3911SP 18257200153183 38-3912SP 18257200153190 38-3913SP 18257200153206 38-3914SP 18257200153213
Recalling firm:
Orthofix U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw; 18-1045SP 11mm X 45mm FIREBIRD SI Screw; 18-1050SP 11mm X 50mm FIREBIRD SI Screw; 18-1055SP 11mm X 55mm FIREBIRD SI Screw; 18-1060SP 11mm X 60mm FIREBIRD SI Screw; 18-1065SP 11mm X 65mm FIREBIRD SI Screw; 18-1070SP 11mm X 70mm FIREBIRD SI Screw; 18-2025SP 12mm X 25mm FIREBIRD SI Screw; 18-2030SP 12mm X 30mm FIREBIRD SI Screw; 18-2035SP 12mm X 35mm FIREBIRD SI Screw; 18-2040SP 12mm X 40mm FIREBIRD SI Screw; 18-2045SP 12mm X 45mm FIREBIRD SI Screw; 18-2050SP 12mm X 50mm FIREBIRD SI Screw; 18-2055SP 12mm X 55mm FIREBIRD SI Screw; 18-2060SP 12mm X 60mm FIREBIRD SI Screw; 18-2065SP 12mm X 65mm FIREBIRD SI Screw; 18-2070SP 12mm X 70mm FIREBIRD SI Screw

Labeling contains claims that are not consistently present.

ALL 50 STATES
Full report

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

Recall #:
97862
Lot/product code:
Lot Code: All Lots/ UDI: 18-1025SP 18257200140084; 18-1030SP 18257200140091; 18-1035SP 18257200140107; 18-1040SP 18257200140114; 18-1045SP 18257200140275; 18-1050SP 18257200140121; 18-1055SP 18257200140138; 18-1060SP 18257200140145; 18-1065SP 18257200140152; 18-1070SP 18257200140169; 18-2025SP 18257200140176; 18-2030SP 18257200140183; 18-2035SP 18257200140190; 18-2040SP 18257200140206; 18-2045SP 18257200140213; 18-2050SP 18257200140220; 18-2055SP 18257200140237; 18-2060SP 18257200140244; 18-2065SP 18257200140251; 18-2070SP 18257200140268
Recalling firm:
Orthofix U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT; 39-9018SP 33W X 28L X 18H, 7DEG PTC IMPLANT; 39-9212SP 33W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-9214SP 33W X 28L X 14H, 12DEG PTC IMPLANT; 39-9216SP 33W X 28L X 16H, 12DEG PTC IMPLANT; 39-9218SP 33W X 28L X 18H, 12DEG PTC IMPLANT; 39-2012SP 37W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-2014SP 37W X 28L X 14H, 7DEG PTC IMPLANT; 39-2016SP 37W X 28L X 16H, 7DEG PTC IMPLANT; 39-2018SP 37W X 28L X 18H, 7DEG PTC IMPLANT; 39-2212SP 37W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-2214SP 37W X 28L X 14H, 12DEG PTC IMPLANT; 39-2216SP 37W X 28L X 16H, 12DEG PTC IMPLANT; 39-2218SP 37W X 28L X 18H, 12DEG PTC IMPLANT;

Labeling contains claims that are not consistently present.

ALL 50 STATES
Full report

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

Recall #:
97862
Lot/product code:
Lot Code: All Lot Codes/ UDI: 39-9012SP 18257200112630 39-9014SP 18257200112647 39-9016SP 18257200112654 39-9018SP 18257200112661 39-9212SP 18257200112678 39-9214SP 18257200112685 39-9216SP 18257200112692 39-9218SP 18257200112708 39-2012SP 18257200112715 39-2014SP 18257200112722 39-2016SP 18257200112739 39-2018SP 18257200112746 39-2212SP 18257200112753 39-2214SP 18257200112760 39-2216SP 18257200112777 39-2218SP 18257200112784
Recalling firm:
Orthofix U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 10H; 38-1011SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 11H; 38-1012SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 12H; 38-1013SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 13H; 38-1014SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 14H; 38-1707SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 7H; 38-1708SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 8H; 38-1709SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 9H; 38-1710SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 10H; 38-1711SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 11H; 38-1712SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 12H; 38-1713SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 13H; 38-1714SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 14H; 38-1807SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 7H; 38-1808SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 8H; 38-1809SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 9H; 38-1810SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 10H; 38-1811SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 11H; 38-1812SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 12H; 38-1813SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 13H; 38-1814SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 14H; 38-3007SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 7H; 38-3008SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 8H; 38-3009SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 9H; 38-3010SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 10H; 38-3011SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 11H; 38-3012SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 12H; 38-3013SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 13H; 38-3014SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 14H; 38-4007SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 7H; 38-4008SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 8H; 38-4009SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 9H; 38-4010SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 10H; 38-4011SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 11H; 38-4012SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 12H; 38-4013SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 13H; 38-4014SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 14H; 38-4207SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 7H; 38-4208SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 8H; 38-4209SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 9H; 38-4210SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 10H; 38-4211SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 11H; 38-4212SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 12H; 38-4213SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 13H; 38-4214SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 14H; 38-4508SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 8H; 38-4509SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 9H; 38-4510SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 10H; 38-4511SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 11H; 38-4512SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 12H; 38-4513SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 13H; 38-4514SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 14H; 38-6007SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 7H; 38-6008SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 8H; 38-6009SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 9H; 38-6010SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 10H; 38-6011SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 11H; 38-6012SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 12H; 38-6013SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 13H; 38-6014SP FORZA PTC Spacer,

Labeling contains claims that are not consistently present.

ALL 50 STATES
Full report

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

Recall #:
97862
Lot/product code:
Lot Code: All Lot codes/ UDI: 38-1007SP 18257200091577 38-1008SP 18257200091584 38-1009SP 18257200091591 38-1010SP 18257200111404 38-1011SP 18257200091614 38-1012SP 18257200091621 38-1013SP 18257200091638 38-1014SP 18257200091645 38-1707SP 18257200092185 38-1708SP 18257200092192 38-1709SP 18257200092208 38-1710SP 18257200092215 38-1711SP 18257200092222 38-1712SP 18257200092239 38-1713SP 18257200092246 38-1714SP 18257200092253 38-1807SP 18257200092024 38-1808SP 18257200092031 38-1809SP 18257200092048 38-1810SP 18257200092055 38-1811SP 18257200092062 38-1812SP 18257200092079 38-1813SP 18257200111305 38-1814SP 18257200092093 38-3007SP 18257200091881 38-3008SP 18257200091898 38-3009SP 18257200091904 38-3010SP 18257200091911 38-3011SP 18257200091928 38-3012SP 18257200091935 38-3013SP 18257200091942 38-3014SP 18257200091959 38-4007SP 18257200091720 38-4008SP 18257200091737 38-4009SP 18257200091744 38-4010SP 18257200091751 38-4011SP 18257200111411 38-4012SP 18257200091775 Part Number GTIN 38-4013SP 18257200091782 38-4014SP 18257200091799 38-4207SP 18257200092109 38-4208SP 18257200092116 38-4209SP 18257200092123 38-4210SP 18257200092130 38-4211SP 18257200092147 38-4212SP 18257200092154 38-4213SP 18257200092161 38-4214SP 18257200092178 38-4508SP 18257200092260 38-4509SP 18257200092277 38-4510SP 18257200092284 38-4511SP 18257200092291 38-4512SP 18257200092307 38-4513SP 18257200092314 38-4514SP 18257200092321 38-6007SP 18257200091805 38-6008SP 18257200091812 38-6009SP 18257200091829 38-6010SP 18257200091836 38-6011SP 18257200091843 38-6012SP 18257200091850 38-6013SP 18257200091867 38-6014SP 18257200091874 38-7008SP 18257200091652 38-7009SP 18257200091669 38-7010SP 18257200091676 38-7011SP 18257200091683 38-7012SP 18257200091690 38-7013SP 18257200091706 38-7014SP 18257200091713 38-9009SP 18257200091966 38-9010SP 18257200091973 38-9011SP 18257200091980 38-9012SP 18257200091997 38-9013SP 18257200092000 38-9014SP 18257200092017
Recalling firm:
Orthofix U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

8 in 1 STI Test Kit

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 7340221704794; SKU: JD-8STI; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Pollen Allergy Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785688; SKU: 1EP; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Melatonin Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785657; SKU: 1ML; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Iron Deficiency Test (ferritin)

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785589; SKU: 1FE; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Iodine Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785572; SKU: 1JO; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Heavy Metals Test

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785749; SKU: 1SM; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2025

Food Intolerance Test Large

Distribution without premarket approval/clearance.

ALL 50 STATES
Full report

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

Recall #:
97896
Lot/product code:
EAN: 616612785640; SKU: 1G2; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling firm:
GET TESTED INTERNATIONAL AB
View official FDA record (opens in a new tab)